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1.
Nat Med ; 30(5): 1276-1283, 2024 May.
Article in English | MEDLINE | ID: mdl-38769431

ABSTRACT

Cervical spinal cord injury (SCI) leads to permanent impairment of arm and hand functions. Here we conducted a prospective, single-arm, multicenter, open-label, non-significant risk trial that evaluated the safety and efficacy of ARCEX Therapy to improve arm and hand functions in people with chronic SCI. ARCEX Therapy involves the delivery of externally applied electrical stimulation over the cervical spinal cord during structured rehabilitation. The primary endpoints were safety and efficacy as measured by whether the majority of participants exhibited significant improvement in both strength and functional performance in response to ARCEX Therapy compared to the end of an equivalent period of rehabilitation alone. Sixty participants completed the protocol. No serious adverse events related to ARCEX Therapy were reported, and the primary effectiveness endpoint was met. Seventy-two percent of participants demonstrated improvements greater than the minimally important difference criteria for both strength and functional domains. Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and sensory abilities and self-reported increases in quality of life. These results demonstrate the safety and efficacy of ARCEX Therapy to improve hand and arm functions in people living with cervical SCI. ClinicalTrials.gov identifier: NCT04697472 .


Subject(s)
Arm , Hand , Quadriplegia , Spinal Cord Injuries , Humans , Quadriplegia/therapy , Quadriplegia/physiopathology , Male , Hand/physiopathology , Female , Middle Aged , Adult , Arm/physiopathology , Spinal Cord Injuries/therapy , Spinal Cord Injuries/physiopathology , Spinal Cord Injuries/rehabilitation , Spinal Cord Stimulation/methods , Treatment Outcome , Quality of Life , Prospective Studies , Chronic Disease , Aged , Electric Stimulation Therapy/methods , Electric Stimulation Therapy/adverse effects
2.
Toxins (Basel) ; 16(2)2024 02 10.
Article in English | MEDLINE | ID: mdl-38393175

ABSTRACT

Since its regulatory approval over a half-century ago, botulinum toxin has evolved from one of the most potent neurotoxins known to becoming routinely adopted in clinical practice. Botulinum toxin, a highly potent neurotoxin produced by Clostridium botulinum, can cause botulism illness, characterized by widespread muscle weakness due to inhibition of acetylcholine transmission at neuromuscular junctions. The observation of botulinum toxin's anticholinergic properties led to the investigation of its potential benefits for conditions with an underlying etiology of cholinergic transmission, including autonomic nervous system dysfunction. These conditions range from disorders of the integument to gastrointestinal and urinary systems. Several formulations of botulinum toxin have been developed and tested over time, significantly increasing the availability of this treatment for appropriate clinical use. Despite the accelerated and expanded use of botulinum toxin, there lacks an updated comprehensive review on its therapeutic use, particularly to treat autonomic dysfunction. This narrative review provides an overview of the effect of botulinum toxin in the treatment of autonomic dysfunction and summarizes the different formulations and dosages most widely studied, while highlighting reported outcomes and the occurrence of any adverse events.


Subject(s)
Autonomic Nervous System Diseases , Botulinum Toxins , Botulism , Clostridium botulinum , Humans , Botulinum Toxins/adverse effects , Botulism/therapy , Neurotoxins , Autonomic Nervous System Diseases/drug therapy
3.
JMIR Public Health Surveill ; 10: e50031, 2024 Feb 23.
Article in English | MEDLINE | ID: mdl-38393781

ABSTRACT

BACKGROUND: Despite the growing accessibility of web-based information related to spinal cord stimulation (SCS), the content and quality of commonly encountered websites remain unknown. OBJECTIVE: This study aimed to assess the content and quality of web-based information on SCS. METHODS: This qualitative study was prospectively registered in Open Science Framework. Google Trends was used to identify the top trending, SCS-related search queries from 2012 to 2022. Top queried terms were then entered into separate search engines. Information found on websites within the first 2 pages of results was extracted and assessed for quality using the DISCERN instrument, the Journal of the American Medical Association benchmark criteria, and the Health on the Net Foundation code of conduct certification. Website readability and SCS-related information were also assessed. RESULTS: After exclusions, 42 unique sites were identified (scientific resources: n=6, nonprofit: n=12, for-profit: n=20, news or media: n=2, and personal or blog: n=2). Overall, information quality was moderate (DISCERN). Few sites met all the Journal of the American Medical Association benchmark criteria (n=3, 7%) or had Health on the Net Foundation certification (n=7, 16%). On average, information was difficult to read, requiring a 9th- to 10th-grade level of reading comprehension. Sites described SCS subcategories (n=14, 33%), indications (n=38, 90%), contraindications (n=14, 33%), side effects or risks (n=28, 66%), device considerations (n=25, 59%), follow-up (n=22, 52%), expected outcomes (n=31, 73%), provided authorship details (n=20, 47%), and publication dates (n=19, 45%). The proportion of for-profit sites reporting authorship information was comparatively less than other site types (n=3, 15%). Almost all sites focused on surgically implanted SCS (n=37, 88%). On average, nonprofit sites contained the greatest number of peer-reviewed reference citations (n=6, 50%). For-profit sites showed the highest proportion of physician or clinical referrals among site types (n=17, 85%) indicating implicit bias (ie, auto-referral). CONCLUSIONS: Overall, our findings suggest the public may be exposed to incomplete or dated information from unidentifiable sources that could put consumers and patient groups at risk.


Subject(s)
Consumer Health Information , Spinal Cord Stimulation , United States , Humans , Comprehension , Reading , Internet
4.
World J Urol ; 42(1): 80, 2024 Feb 15.
Article in English | MEDLINE | ID: mdl-38358540

ABSTRACT

PURPOSE: Spinal cord injury (SCI) leads to sensorimotor impairments; however, it can also be complicated by significant autonomic dysfunction, including cardiovascular and lower urinary tract (LUT) dysfunctions. Autonomic dysreflexia (AD) is a dangerous cardiovascular complication of SCI often overlooked by healthcare professionals. AD is characterized by a sudden increase in blood pressure (BP) that can result in severe cardiovascular and cerebrovascular complications. In this review, we provide an overview on the clinical manifestations, risk factors, underlying mechanisms, and current approaches in prevention and management of AD. METHODS: After conducting a literature research, we summarized relevant information regarding the clinical and pathophysiological aspects in the context of urological clinical practice CONCLUSIONS: The most common triggers of AD are those arising from LUT, such as bladder distention and urinary tract infections. Furthermore, AD is commonly observed in individuals with SCI during urological procedures, including catheterization, cystoscopy and urodynamics. Although significant progress in the clinical assessment of AD has been made in recent decades, effective approaches for its prevention and treatment are currently lacking.


Subject(s)
Autonomic Dysreflexia , Spinal Cord Injuries , Humans , Autonomic Dysreflexia/etiology , Autonomic Dysreflexia/prevention & control , Spinal Cord Injuries/complications , Spinal Cord Injuries/therapy , Blood Pressure , Cystoscopy , Health Personnel
5.
J Neurotrauma ; 2024 Jan 31.
Article in English | MEDLINE | ID: mdl-38214089

ABSTRACT

Autonomic dysreflexia (AD) is a common autonomic complication of spinal cord injury (SCI) characterized by a sudden increase is blood pressure triggered by peripheral stimulation, such as bladder distention. Iatrogenic AD events often occur during various medical procedures including urodynamic assessments (UDSs) used to evaluate lower urinary tract (LUT) function in individuals with SCI. To date, there are no established clinical practices that would allow early detection of the development of episodes of AD. Heart rate variability (HRV) is a reliable and non-invasive metric for evaluating autonomic regulation of the cardiovascular system, with demonstrated utility in people with SCI during UDSs. We aim to provide a comprehensive evaluation of cardiovascular function during UDS-induced AD using ultra-short-term HRV analysis and identify changes in cardiovascular dynamics to predict the onset of AD. We assessed cardiovascular data in a total of 24 participants with sensorimotor complete SCI above T6 (17 males, 7 females, median age = 43 [36-50] years) who experienced AD during UDS. We used continuous electrocardiographic recordings to evaluate HRV in 60 sec overlapping windows during filling cystometry. The mean of "normal-to-normal" heartbeats (meanNN), its standard deviation (SDNN), and the root mean square of successive differences (RMSSD) were calculated and used in all subsequent analyses. We found that SDNN and RMSSD diminished during the early phase of bladder filling and sharply increased during AD. Using the lowest point of statistical variability in heart rate (i.e., SDNN), we were able to predict AD events within 240 sec (percentile 25-percentile 75: 172-339 sec) before the first systolic blood pressure peak after AD onset (sensitivity = 0.667; specificity = 0.875). Our results indicated a temporary increase in sympathetic activity during the early phase of bladder filling, which is followed by an increase in parasympathetic outflow to the heart when AD occurs. These findings have significant clinical implications that extend beyond the context of UDS and demonstrate the importance of identifying early changes in HRV in order to accurately predict AD episodes in people living with SCI.

6.
J Neural Eng ; 21(1)2024 02 07.
Article in English | MEDLINE | ID: mdl-38271712

ABSTRACT

Objective.Electrical spinal cord stimulation (SCS) has emerged as a promising therapy for recovery of motor and autonomic dysfunctions following spinal cord injury (SCI). Despite the rise in studies using SCS for SCI complications, there are no standard guidelines for reporting SCS parameters in research publications, making it challenging to compare, interpret or reproduce reported effects across experimental studies.Approach.To develop guidelines for minimum reporting standards for SCS parameters in pre-clinical and clinical SCI research, we gathered an international panel of expert clinicians and scientists. Using a Delphi approach, we developed guideline items and surveyed the panel on their level of agreement for each item.Main results.There was strong agreement on 26 of the 29 items identified for establishing minimum reporting standards for SCS studies. The guidelines encompass three major SCS categories: hardware, configuration and current parameters, and the intervention.Significance.Standardized reporting of stimulation parameters will ensure that SCS studies can be easily analyzed, replicated, and interpreted by the scientific community, thereby expanding the SCS knowledge base and fostering transparency in reporting.


Subject(s)
Spinal Cord Injuries , Spinal Cord Stimulation , Humans , Spinal Cord Stimulation/methods , Spinal Cord
7.
J Clin Med ; 12(24)2023 Dec 13.
Article in English | MEDLINE | ID: mdl-38137732

ABSTRACT

Heart rate variability biofeedback (HRV-F) is a neurocardiac self-regulation therapy that aims to regulate cardiac autonomic nervous system activity and improve cardiac balance. Despite benefits in various clinical populations, no study has reported the effects of HRV-F in adults with a spinal cord injury (SCI). This article provides an overview of a neuropsychophysiological laboratory framework and reports the impact of an HRV-F training program on two adults with chronic SCI (T1 AIS A and T3 AIS C) with different degrees of remaining cardiac autonomic function. The HRV-F intervention involved 10 weeks of face-to-face and telehealth sessions with daily HRV-F home practice. Physiological (HRV, blood pressure variability (BPV), baroreflex sensitivity (BRS)), and self-reported assessments (Fatigue Severity Scale, Generalised Anxiety Disorder Scale, Patient Health Questionnaire, Appraisal of Disability and Participation Scale, EuroQol Visual Analogue Scale) were conducted at baseline and 10 weeks. Participants also completed weekly diaries capturing mood, anxiety, pain, sleep quality, fatigue, and adverse events. Results showed some improvement in HRV, BPV, and BRS. Additionally, participants self-reported some improvements in mood, fatigue, pain, quality of life, and self-perception. A 10-week HRV-F intervention was feasible in two participants with chronic SCI, warranting further investigation into its autonomic and psychosocial effects.

8.
J Clin Med ; 12(22)2023 Nov 07.
Article in English | MEDLINE | ID: mdl-38002586

ABSTRACT

Neurogenic bowel dysfunction (NBD) is a common condition in individuals with spinal cord injury (SCI) or multiple sclerosis (MS). It usually entails constipation, difficult evacuation of the rectum, and fecal incontinence (FI); often in combination. It is highly burdensome for affected patients and is correlated with poor quality of life. The current treatment algorithm, or treatment pyramid, does not completely correspond to actual clinical practice, and the known and classical pyramid contains both treatments still in their experimental stage as well as several treatments which are not available at all treatment centers. Thus, an updated treatment algorithm is called upon, and the authors of this paper therefore propose a simplified version of the treatment pyramid, aiming to guide clinicians in treating NBD.

9.
PLoS Med ; 20(11): e1004082, 2023 Nov.
Article in English | MEDLINE | ID: mdl-38011304

ABSTRACT

BACKGROUND: A low level of cardiorespiratory fitness [CRF; defined as peak oxygen uptake ([Formula: see text]O2peak) or peak power output (PPO)] is a widely reported consequence of spinal cord injury (SCI) and a major risk factor associated with chronic disease. However, CRF can be modified by exercise. This systematic review with meta-analysis and meta-regression aimed to assess whether certain SCI characteristics and/or specific exercise considerations are moderators of changes in CRF. METHODS AND FINDINGS: Databases (MEDLINE, EMBASE, CENTRAL, and Web of Science) were searched from inception to March 2023. A primary meta-analysis was conducted including randomised controlled trials (RCTs; exercise interventions lasting >2 weeks relative to control groups). A secondary meta-analysis pooled independent exercise interventions >2 weeks from longitudinal pre-post and RCT studies to explore whether subgroup differences in injury characteristics and/or exercise intervention parameters explained CRF changes. Further analyses included cohort, cross-sectional, and observational study designs. Outcome measures of interest were absolute (A[Formula: see text]O2peak) or relative [Formula: see text]O2peak (R[Formula: see text]O2peak), and/or PPO. Bias/quality was assessed via The Cochrane Risk of Bias 2 and the National Institute of Health Quality Assessment Tools. Certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Random effects models were used in all meta-analyses and meta-regressions. Of 21,020 identified records, 120 studies comprising 29 RCTs, 67 pre-post studies, 11 cohort, 7 cross-sectional, and 6 observational studies were included. The primary meta-analysis revealed significant improvements in A[Formula: see text]O2peak [0.16 (0.07, 0.25) L/min], R[Formula: see text]O2peak [2.9 (1.8, 3.9) mL/kg/min], and PPO [9 (5, 14) W] with exercise, relative to controls (p < 0.001). Ninety-six studies (117 independent exercise interventions comprising 1,331 adults with SCI) were included in the secondary, pooled meta-analysis which demonstrated significant increases in A[Formula: see text]O2peak [0.22 (0.17, 0.26) L/min], R[Formula: see text]O2peak [2.8 (2.2, 3.3) mL/kg/min], and PPO [11 (9, 13) W] (p < 0.001) following exercise interventions. There were subgroup differences for R[Formula: see text]O2peak based on exercise modality (p = 0.002) and intervention length (p = 0.01), but there were no differences for A[Formula: see text]O2peak. There were subgroup differences (p ≤ 0.018) for PPO based on time since injury, neurological level of injury, exercise modality, and frequency. The meta-regression found that studies with a higher mean age of participants were associated with smaller changes in A[Formula: see text]O2peak and R[Formula: see text]O2peak (p < 0.10). GRADE indicated a moderate level of certainty in the estimated effect for R[Formula: see text]O2peak, but low levels for A[Formula: see text]O2peak and PPO. This review may be limited by the small number of RCTs, which prevented a subgroup analysis within this specific study design. CONCLUSIONS: Our primary meta-analysis confirms that performing exercise >2 weeks results in significant improvements to A[Formula: see text]O2peak, R[Formula: see text]O2peak, and PPO in individuals with SCI. The pooled meta-analysis subgroup comparisons identified that exercise interventions lasting up to 12 weeks yield the greatest change in R[Formula: see text]O2peak. Upper-body aerobic exercise and resistance training also appear the most effective at improving R[Formula: see text]O2peak and PPO. Furthermore, acutely injured, individuals with paraplegia, exercising for ≥3 sessions/week will likely experience the greatest change in PPO. Ageing seemingly diminishes the adaptive CRF responses to exercise training in individuals with SCI. REGISTRATION: PROSPERO: CRD42018104342.


Subject(s)
Exercise , Spinal Cord Injuries , Adult , Humans , Cross-Sectional Studies , Exercise/physiology , Chronic Disease , Observational Studies as Topic
10.
Front Neurol ; 14: 1245881, 2023.
Article in English | MEDLINE | ID: mdl-37794879

ABSTRACT

Background: High blood pressure (BP) is the primary risk factor for recurrent strokes. Despite established clinical guidelines, some stroke survivors exhibit uncontrolled BP over the first 12 months post-stroke. Furthermore, research on BP trajectories in stroke survivors admitted to inpatient rehabilitation hospitals is limited. Exercise is recommended to reduce BP after stroke. However, the effect of high repetition gait training at aerobic intensities (>40% heart rate reserve; HRR) during inpatient rehabilitation on BP is unclear. We aimed to determine the effect of an aerobic gait training intervention on BP trajectory over the first 12 months post-stroke. Methods: This is a secondary analysis of the Determining Optimal Post-Stroke Exercise (DOSE) trial. Participants with stroke admitted to inpatient rehabilitation hospitals were recruited and randomized to usual care (n = 24), DOSE1 (n = 25; >2,000 steps, 40-60% HRR for >30 min/session, 20 sessions over 4 weeks), or DOSE2 (n = 25; additional DOSE1 session/day) groups. Resting BP [systolic (SBP) and diastolic (DBP)] was measured at baseline (inpatient rehabilitation admission), post-intervention (near inpatient discharge), 6- and 12-month post-stroke. Linear mixed-effects models were used to examine the effects of group and time (weeks post-stroke) on SBP, DBP and hypertension (≥140/90 mmHg; ≥130/80 mmHg, if diabetic), controlling for age, stroke type, and baseline history of hypertension. Results: No effect of intervention group on SBP, DBP, or hypertension was observed. BP increased from baseline to 12-month post-stroke for SBP (from [mean ± standard deviation] 121.8 ± 15.0 to 131.8 ± 17.8 mmHg) and for DBP (74.4 ± 9.8 to 78.5 ± 10.1 mmHg). The proportion of hypertensive participants increased from 20.8% (n = 15/72) to 32.8% (n = 19/58). These increases in BP were statistically significant: an effect [estimation (95%CI), value of p] of time was observed on SBP [0.19 (0.12-0.26) mmHg/week, p < 0.001], DBP [0.09 (0.05-0.14) mmHg/week, p < 0.001], and hypertension [OR (95%CI): 1.03 (1.01-1.05), p = 0.010]. A baseline history of hypertension was associated with higher SBP by 13.45 (8.73-18.17) mmHg, higher DBP by 5.57 (2.02-9.12) mmHg, and 42.22 (6.60-270.08) times the odds of being hypertensive at each timepoint, compared to those without. Conclusion: Blood pressure increased after inpatient rehabilitation over the first 12 months post-stroke, especially among those with a history of hypertension. The 4-week aerobic gait training intervention did not influence this trajectory.

11.
Br J Nurs ; 32(18): S8-S16, 2023 Oct 12.
Article in English | MEDLINE | ID: mdl-37830866

ABSTRACT

BACKGROUND: Evidence shows that intermittent catheterisation (IC) for bladder emptying is linked to urinary tract infections (UTIs) and poor quality of life (QoL). AIM: To investigate the association between UTI risk factors and QoL and patient-reported UTIs respectively. METHODS: A survey was distributed to IC users from 13 countries. FINDINGS: Among 3464 respondents, a significantly poorer QoL was observed when experiencing blood in the urine, residual urine, bowel dysfunction, recurrent UTIs, being female, and applying withdrawal techniques. A lower UTI risk was found when blood was not apparent in urine (RR: 0.63; 95% CI: 0.55-0.71), the bladder was perceived empty (RR: 0.83; 95% CI: 0.72-0.96), not having bowel dysfunction (RR: 0.86; 95% CI: 0.76-0.98), and being male (RR: 0.70; 95% CI: 0.62-0.79). CONCLUSION: This study underlines the importance of risk factors and their link to QoL and UTIs, highlighting the need for addressing symptoms before UTIs become problematic.


Subject(s)
Quality of Life , Urinary Tract Infections , Humans , Male , Female , Urinary Tract Infections/epidemiology , Urinary Tract Infections/etiology , Urinary Bladder , Risk Factors , Catheters/adverse effects , Urinary Catheterization/adverse effects , Urinary Catheterization/methods
12.
Spinal Cord ; 61(12): 644-651, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37814014

ABSTRACT

STUDY DESIGN: Observational study. OBJECTIVES: To assess the construct validity of the International Standards to Document Remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) (2012 1st Edition). SETTING: Two Canadian spinal cord injury (SCI) centers. METHODS: Data were collected between 2011-2014. Assessments included the ISAFSCI, standardized measures of autonomic function and a clinical examination. Construct validity of ISAFSCI was assessed by testing a priori hypotheses on expected ISAFSCI responses to standard measures (convergent hypotheses) and clinical variables (clinical hypotheses). RESULTS: Forty-nine participants with an average age of 45 ± 12 years were included, of which 42 (85.7%) were males, 37 (77.6%) had a neurological level of injury at or above T6, and 23 (46.9%) were assessed as having motor and sensory complete SCI. For the six General Autonomic Function component hypotheses, two hypotheses (1 clinical, 1 convergent) related to autonomic control of blood pressure and one clinical hypothesis for temperature regulation were statistically significant. In terms of the Lower Urinary Tract, Bowel and Sexual Function component of the ISAFSCI, all the hypotheses (5 convergent, 3 clinical) were statistically significant except for the hypotheses on female sexual items (2 convergent, 2 clinical), likely due to small sample size. CONCLUSION: The construct validity of ISAFSCI (2012 1st Edition) for the General Autonomic Function component was considered to be weak while it was much stronger for the Lower Urinary Tract, Bowel and Sexual Function component based on a priori hypotheses. These results can inform future psychometric studies of the ISAFSCI (2021 2nd Edition).


Subject(s)
Autonomic Nervous System Diseases , Spinal Cord Injuries , Male , Humans , Female , Adult , Middle Aged , Spinal Cord Injuries/diagnosis , Canada , Autonomic Nervous System/physiology , Autonomic Nervous System Diseases/diagnosis , Autonomic Nervous System Diseases/etiology , Urinary Bladder
13.
Neuromodulation ; 2023 Sep 02.
Article in English | MEDLINE | ID: mdl-37665302

ABSTRACT

BACKGROUND AND OBJECTIVES: There are many potential etiologies of impaired cardiovascular control, from chronic stress to neurodegenerative conditions or central nervous system lesions. Since 1959, spinal cord stimulation (SCS) has been reported to modulate blood pressure (BP), heart rate (HR), and HR variability (HRV), yet the specific stimulation sites and parameters to induce a targeted cardiovascular (CV) change for mitigating abnormal hemodynamics remain unclear. To investigate the ability and parameters of SCS to modulate the CV, we reviewed clinical studies using SCS with reported HR, BP, or HRV findings. MATERIALS AND METHODS: A keyword-based electronic search was conducted through MEDLINE, Embase, and PubMed data bases, last searched on February 3, 2023. Inclusion criteria were studies with human participants receiving SCS with comparison with SCS turned off, with reporting of either HR, HRV, or BP findings. Non-English studies, conference abstracts, and studies not reporting standalone effects of SCS when comparing SCS with non-SCS interventions were excluded. Results were plotted for visual analysis. When available, participant-specific stimulation parameters and effects were extracted and quantitatively analyzed using ordinary least squares regression. RESULTS: A total of 59 studies were included in this review; 51 studies delivered SCS invasively through implanted/percutaneous leads. Eight studies used noninvasive, transcutaneous electrodes. We found numerous reports of cervical, high thoracic, and mid-to-low thoracolumbar SCS increasing resting BP, and cervical/mid-to-low thoracolumbar SCS decreasing BP. The effect of SCS location on HR and HRV was equivocal. We were unable to analyze stimulation parameters owing to inadequate parameter reporting in many publications. CONCLUSIONS: Our findings suggest CV neuromodulation, particularly BP modulation, with SCS to be a promising frontier. Further research with larger randomized controlled trials and detailed reporting of SCS parameters will be necessary for appropriate evaluation of SCS as a CV therapy.

14.
Front Neurosci ; 17: 1221809, 2023.
Article in English | MEDLINE | ID: mdl-37564370

ABSTRACT

Introduction: Cerebral palsy (CP) affects up to 4 children in 1,000 live births, making it the most common motor disorder in children. It impairs the child's ability to move voluntarily and maintain balance and posture, and results in a wide range of other functional disorders during early development impairments in various sensory modalities, e.g., vision, hearing ability and proprioception. Current standard of care therapy focuses on symptom management and does not mitigate the progression of many of these underlying neurological impairments. The goal of this trial is to conduct a prospective multicenter, double-blinded, sham-controlled, crossover, randomized control trial to demonstrate the safety and efficacy of noninvasive spinal cord neuromodulation (SCiP™, SpineX Inc.) in conjunction with activity-based neurorehabilitation therapy (ABNT) to improve voluntary sensorimotor function in children with cerebral palsy. Methods and analysis: Sixty participants (aged 2-13 years) diagnosed with CP classified as Gross Motor Function Classification Scale Levels I-V will be recruited and divided equally into two groups (G1 and G2). Both groups will receive identical ABNT 2 days/wk. G1 will initially receive sham stimulation, whereas G2 will receive therapeutic SCiP™ therapy for 8 weeks. After 8 weeks, G1 will cross over and receive therapeutic SCiP™ therapy for 8 weeks, whereas G2 will continue to receive SCiP™ therapy for another 8 weeks, for a total of 16 weeks. Primary and secondary outcome measures will include Gross Motor Function Measure-88 and Modified Ashworth Scale, respectively. Frequency and severity of adverse events will be established by safety analyses. Ethics and dissemination: The trial is registered on clinicaltrials.gov (NCT05720208). The results from this trial will be reported on clinicaltrials.gov, published in peer-reviewed journals and presented at scientific and clinical conferences.

15.
BMJ Open ; 13(7): e070544, 2023 07 14.
Article in English | MEDLINE | ID: mdl-37451734

ABSTRACT

INTRODUCTION: Motor and autonomic dysfunctions are widespread among people with spinal cord injury (SCI), leading to poor health and reduced quality of life. Exercise interventions, such as locomotor training (LT), can promote sensorimotor and autonomic recovery post SCI. Recently, breakthroughs in SCI research have reported beneficial effects of electrical spinal cord stimulation (SCS) on motor and autonomic functions. Despite literature supporting the independent benefits of transcutaneous SCS (TSCS) and LT, the effect of pairing TSCS with LT is unknown. These therapies are non-invasive, customisable and have the potential to simultaneously benefit both sensorimotor and autonomic functions. The aim of this study is to assess the effects of LT paired with TSCS in people with chronic SCI on outcomes of sensorimotor and autonomic function. METHODS AND ANALYSIS: Twelve eligible participants with chronic (>1 year) motor-complete SCI, at or above the sixth thoracic segment, will be enrolled in this single-blinded, randomised sham-controlled trial. Participants will undergo mapping for optimisation of stimulation parameters and baseline assessments of motor and autonomic functions. Participants will then be randomly assigned to either LT+TSCS or LT+Sham stimulation for 12 weeks, after which postintervention assessments will be performed to determine the effect of TSCS on motor and autonomic functions. The primary outcome of interest is attempted voluntary muscle activation using surface electromyography. The secondary outcomes relate to sensorimotor function, cardiovascular function, pelvic organ function and health-related quality of life. Statistical analysis will be performed using two-way repeated measures Analysis of variance (ANOVAs) or Kruskal-Wallis and Cohen's effect sizes. ETHICS AND DISSEMINATION: This study has been approved after full ethical review by the University of British Columbia's Research Ethics Board. The stimulator used in this trial has received Investigation Testing Authorisation from Health Canada. Trial results will be disseminated through peer-reviewed publications, conference presentations and seminars. TRIAL REGISTRATION NUMBER: NCT04726059.


Subject(s)
Quality of Life , Spinal Cord Injuries , Humans , Spinal Cord Injuries/complications , Spinal Cord Injuries/therapy , Exercise , Physical Therapy Modalities , Muscle, Skeletal , Spinal Cord
16.
Biomedicines ; 11(7)2023 Jul 07.
Article in English | MEDLINE | ID: mdl-37509568

ABSTRACT

Despite the risk of developing catheter-associated urinary tract infections (CAUTI), catheter reuse is common among people with spinal cord injury (SCI). This study examined the microbiological burden and catheter surface changes associated with short-term reuse. Ten individuals with chronic SCI reused their catheters over 3 days. Urine and catheter swab cultures were collected daily for analysis. Scanning electron microscopy (SEM) and X-ray photoelectron spectroscopy (XPS) analyses were used to assess catheter surface changes. Catheter swab cultures showed no growth after 48 h (47.8%), skin flora (28.9%), mixed flora (17.8%), or bacterial growth (5.5%). Asymptomatic bacteriuria was found for most participants at baseline (n = 9) and all at follow-up (n = 10). Urine samples contained Escherichia coli (58%), Klebsiella pneumoniae (30%), Enterococcus faecalis (26%), Acinetobacter calcoaceticus-baumannii (10%), Pseudomonas aeruginosa (6%) or Proteus vulgaris (2%). Most urine cultures showed resistance to one or more antibiotics (62%). SEM images demonstrated structural damage, biofilm and/or bacteria on all reused catheter surfaces. XPS analyses also confirmed the deposition of bacterial biofilm on reused catheters. Catheter surface changes and the presence of antibiotic-resistant bacteria were evident following short-term reuse, which may increase susceptibility to CAUTI in individuals with SCI despite asymptomatic bacteriuria.

17.
BMC Womens Health ; 23(1): 254, 2023 05 11.
Article in English | MEDLINE | ID: mdl-37170080

ABSTRACT

BACKGROUND: On March 24, 2020, the Mexican Government established social distancing measures to address the outbreak of the COVID-19 pandemic. The resulting home confinement affected daily lifestyle habits such as eating, sleeping, and physical activity (PA). The objectives of this study were to determine changes in PA behaviors among Mexican women due to the COVID-19 pandemic and to assess potential factors associated with these changes. METHODS: This was a cross-sectional study based on an anonymous online questionnaire developed by the Task Force on Physical Activity for Persons with Disabilities (PAPD) within the International Society of Physical and Rehabilitation Medicine (ISPRM). Descriptive, quantitative statistics were used for data analysis. A Chi-squared (χ²) test was used to explore associations between dependent and independent variables. RESULTS: A total of 1882 surveys were completed. Among the respondents, 53.3% declared that their PA was reduced during the pandemic, 26.6% reported similar PA behavior, and 20.1% declared that their PA had increased during the pandemic. Lower PA behavior during the pandemic was associated with lower education levels, stricter pandemic constraints, obesity, and lower self-perceived functioning levels. A statistically significant association between poorer self-perceived mental health and decreased PA behaviors was also found. Respondents who were younger, self-perceived as unimpaired, not overweight, and whose income was not impacted by COVID-19 were associated with higher levels of reported physical and mental health. CONCLUSIONS: The study results identify disparities experienced in PA behavior during the COVID-19 pandemic among Mexican women and highlights the need for social support for PA participation.


Subject(s)
COVID-19 , Exercise , Health Behavior , Cross-Sectional Studies , Humans , Female , Pandemics , Mexico , Adult , Middle Aged , Aged
18.
J Neuroeng Rehabil ; 20(1): 59, 2023 05 03.
Article in English | MEDLINE | ID: mdl-37138361

ABSTRACT

Multiple studies have corroborated the restoration of volitional motor control after motor-complete spinal cord injury (SCI) through the use of epidural spinal cord stimulation (eSCS), but rigorous quantitative descriptions of muscle coordination have been lacking. Six participants with chronic, motor and sensory complete SCI underwent a brain motor control assessment (BMCA) consisting of a set of structured motor tasks with and without eSCS. We investigated how muscle activity complexity and muscle synergies changed with and without stimulation. We performed this analysis to better characterize the impact of stimulation on neuromuscular control. We also recorded data from nine healthy participants as controls. Competition exists between the task origin and neural origin hypotheses underlying muscle synergies. The ability to restore motor control with eSCS in participants with motor and sensory complete SCI allows us to test whether changes in muscle synergies reflect a neural basis in the same task. Muscle activity complexity was computed with Higuchi Fractal Dimensional (HFD) analysis, and muscle synergies were estimated using non-negative matrix factorization (NNMF) in six participants with American Spinal Injury Association (ASIA) Impairment Score (AIS) A. We found that the complexity of muscle activity was immediately reduced by eSCS in the SCI participants. We also found that over the follow-up sessions, the muscle synergy structure of the SCI participants became more defined, and the number of synergies decreased over time, indicating improved coordination between muscle groups. Lastly, we found that the muscle synergies were restored with eSCS, supporting the neural hypothesis of muscle synergies. We conclude that eSCS restores muscle movements and muscle synergies that are distinct from those of healthy, able-bodied controls.


Subject(s)
Spinal Cord Injuries , Spinal Cord Stimulation , Humans , Muscle, Skeletal/physiology , Electromyography , Spinal Cord Stimulation/methods , Spinal Cord
19.
Front Neurosci ; 17: 1155796, 2023.
Article in English | MEDLINE | ID: mdl-37179555

ABSTRACT

Sexual dysfunction is a common consequence for women with spinal cord injury (SCI); however, current treatments are ineffective, especially in the under-prioritized population of women with SCI. This case-series, a secondary analysis of the Epidural Stimulation After Neurologic Damage (E-STAND) clinical trial aimed to investigate the effect of epidural spinal cord stimulation (ESCS) on sexual function and distress in women with SCI. Three females, with chronic, thoracic, sensorimotor complete SCI received daily (24 h/day) tonic ESCS for 13 months. Questionnaires, including the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale (FSDS) were collected monthly. There was a 3.2-point (13.2%) mean increase in total FSFI from baseline (24.5 ± 4.1) to post-intervention (27.8 ± 6.6), with a 4.8-50% improvement in the sub-domains of desire, arousal, orgasm and satisfaction. Sexual distress was reduced by 55%, with a mean decrease of 12 points (55.4%) from baseline (21.7 ± 17.2) to post-intervention (9.7 ± 10.8). There was a clinically meaningful change of 14 points in the International Standards for Neurological Classification of Spinal Cord Injury total sensory score from baseline (102 ± 10.5) to post-intervention (116 ± 17.4), without aggravating dyspareunia. ESCS is a promising treatment for sexual dysfunction and distress in women with severe SCI. Developing therapeutic interventions for sexual function is one of the most meaningful recovery targets for people with SCI. Additional large-scale investigations are needed to understand the long-term safety and feasibility of ESCS as a viable therapy for sexual dysfunction. Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT03026816, NCT03026816.

20.
J Clin Med ; 12(8)2023 Apr 16.
Article in English | MEDLINE | ID: mdl-37109234

ABSTRACT

Spinal cord injury (SCI) results in severe cardiovascular dysfunction due to the disruption of supraspinal control. Autonomic dysreflexia (AD), an uncontrolled rise in blood pressure in response to peripheral stimuli including common bowel routine, digital anorectal stimulation (DARS), reduces the quality of life, and increases morbidity and mortality. Recently, spinal cord stimulation (SCS) has emerged as a potential intervention to mitigate unstable blood pressure following SCI. The objective of this case series was to test the real-time effect of epidural SCS (eSCS) at the lumbosacral spinal cord, the most common implant location, on mitigating AD in individuals with SCI. We recruited three individuals with cervical and upper thoracic motor-complete SCI who have an implanted epidural stimulator. We demonstrated that eSCS can reduce the elevation in blood pressure and prevent DARS-induced AD. The blood pressure variability analysis indicated that eSCS potentially reduced vascular sympathetic nervous system activity during DARS, compared to without eSCS. This case series provides evidence to support the use of eSCS to prevent AD episodes during routine bowel procedures, improving the quality of life for individuals with SCI and potentially reducing cardiovascular risks.

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