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PURPOSE: There is limited caregiver-reported evidence determining health care transition (HCT) outcomes for their adolescents/young adults with special health care needs (AYA-SHCN). A subcommittee of the International and Interdisciplinary Healthcare Transition Research Consortium aimed to identify multidimensional outcomes of a successful HCT among AYA-SHCN based on parents/caregivers' perspectives. METHODS: After literature review and expert interviews, a three-stage Delphi process identified HCT outcomes based on parents/caregivers' perspectives. Participants were parents/caregivers of patients attending the Victory Junction Therapeutic Camp and a nationally representative sample from Cint Healthcare Digital Solutions Platform. The cumulative 272 responses collected on a Health Insurance Portability and Accountability Act-compliant web-based engine (Qualtrics) rated potential HCT outcomes by level of importance on a Likert scale from 1 (not important) to 9 (very important) and narrowed in subsequent iterations. RESULTS: The Delphi process included 127 (Stage 1), 82 (Stage 2), and 63 (Stage 3) parents/caregivers. The initial 25 HCT outcomes were narrowed to 13, across four major domains: coping/satisfaction, behavioral, structural, and HCT/healthcare-focused outcomes. The top outcome was "My child takes their medications as prescribed." Several traditionally considered important outcomes for HCT were eliminated. DISCUSSION: Thirteen HCT outcomes for AYA-SHCN were identified in four major domains: coping/satisfaction, behavioral, structural, and HCT/healthcare focused. Future research in larger samples would allow stratification to represent diverse patients and caregiver populations. Identifying international consensus-derived outcomes among parents/caregivers is imperative for the evaluation of HCT preparation strategies that ensure appropriate support for diverse AYA-SHCN and their families during this process and enable implementation of the most effective interventions.
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Although clinical trials have shown that denosumab significantly increases bone mineral density at key skeletal sites more than oral bisphosphonates, evidence is lacking from head-to-head randomized trials evaluating fracture outcomes. This retrospective cohort study uses administrative claims data from Medicare fee-for service beneficiaries to evaluate the comparative effectiveness of denosumab vs alendronate in reducing fracture risk among women with PMO in the US. Women with PMO ≥ 66 yr of age with no prior history of osteoporosis treatment, who initiated denosumab (n = 89 115) or alendronate (n = 389 536) from 2012 to 2018, were followed from treatment initiation until the first of a specific fracture outcome, treatment discontinuation or switch, end of study (December 31, 2019), or other censoring criteria. A doubly robust inverse-probability of treatment and censoring weighted function was used to estimate the risk ratio associated with the use of denosumab compared with alendronate for hip, nonvertebral (NV; includes hip, humerus, pelvis, radius/ulna, other femur), non-hip nonvertebral (NHNV), hospitalized vertebral (HV), and major osteoporotic (MOP; consisting of NV and HV) fractures. Overall, denosumab reduced the risk of MOP by 39%, hip by 36%, NV by 43%, NHNV by 50%, and HV fractures by 30% compared with alendronate. Denosumab reduced the risk of MOP fractures by 9% at year 1, 12% at year 2, 18% at year 3, and 31% at year 5. An increase in the magnitude of fracture risk reduction with increasing duration of exposure was also observed for other NV fracture outcomes. In this cohort of almost half-a-million treatment-naive women with PMO, we observed clinically significant reductions in the risk of MOP, hip, NV, NHNV, and HV fractures for patients on denosumab compared with alendronate. Patients who remained on denosumab for longer periods of time experienced greater reductions in fracture risk.
Osteoporosis-related fractures can have a significant impact on the health and quality of life of women with postmenopausal osteoporosis, as well as pose a significant burden to society. Although clinical trials have shown that denosumab is more effective at increasing bone mineral density compared with alendronate, there is a lack of evidence evaluating the fracture risk between these 2 commonly used osteoporosis therapies. In this study using Medicare claims data for almost 500 000 women with postmenopausal osteoporosis with no prior history of osteoporosis medication use, we compared the risk of fracturean important outcome to patients and health care providersbetween denosumab and alendronate. Advanced analytic methods were implemented to ensure the study results were valid and were not unduly influenced by biases common in observational studies. We observed clinically meaningful reductions (from 30% up to 50%) in the risk of hip, nonvertebral, non-hip nonvertebral, hospitalized vertebral, and major osteoporotic fractures for patients treated with denosumab compared with alendronate. Patients who remained on denosumab for longer periods of time experienced greater reductions in fracture risk than those who remained on alendronate.
Subject(s)
Alendronate , Denosumab , Osteoporosis, Postmenopausal , Humans , Denosumab/therapeutic use , Alendronate/therapeutic use , Female , Aged , Osteoporosis, Postmenopausal/drug therapy , Aged, 80 and over , Retrospective Studies , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/epidemiologyABSTRACT
BACKGROUND: Low-intensity transcranial ultrasound stimulation (TUS) is a noninvasive brain stimulation (NIBS) technique with high spatial specificity. Previous studies showed that TUS delivered in a theta burst pattern (tbTUS) increased motor cortex (MI) excitability up to 30 minutes due to long-term potentiation (LTP)-like plasticity. Studies using other forms of NIBS suggested that cortical plasticity may be impaired in patients with Parkinson's disease (PD). OBJECTIVE: The aim was to investigate the neurophysiological effects of tbTUS in PD patients off and on dopaminergic medications compared to healthy controls. METHODS: We studied 20 moderately affected PD patients in on and off dopaminergic medication states (7 with and 13 without dyskinesia) and 17 age-matched healthy controls in a case-controlled study. tbTUS was applied for 80 seconds to the MI. Motor-evoked potentials (MEP), short-interval intracortical inhibition (SICI), and short-interval intracortical facilitation (SICF) were recorded at baseline, and at 5 minutes (T5), T30, and T60 after tbTUS. Motor Unified Parkinson's Disease Rating Scale (mUPDRS) was measured at baseline and T60. RESULTS: tbTUS significantly increased MEP amplitude at T30 compared to baseline in controls and in PD patients on but not in PD patients off medications. SICI was reduced in PD off medications compared to controls. tbTUS did not change in SICI or SICF. The bradykinesia subscore of mUPDRS was reduced at T60 compared to baseline in PD on but not in the off medication state. The presence of dyskinesia did not affect tbTUS-induced plasticity. CONCLUSIONS: tbTUS-induced LTP plasticity is impaired in PD patients off medications and is restored by dopaminergic medications. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
Subject(s)
Evoked Potentials, Motor , Motor Cortex , Neuronal Plasticity , Parkinson Disease , Humans , Parkinson Disease/physiopathology , Parkinson Disease/therapy , Male , Female , Middle Aged , Aged , Evoked Potentials, Motor/physiology , Evoked Potentials, Motor/drug effects , Motor Cortex/physiopathology , Neuronal Plasticity/physiology , Neuronal Plasticity/drug effects , Case-Control Studies , Transcranial Magnetic Stimulation/methods , Theta Rhythm/physiologyABSTRACT
OBJECTIVE: Corticospinal inhibitory mechanisms are relevant to functional recovery but remain poorly understood after spinal cord injury (SCI). Post-injury characteristics of contralateral silent period (CSP), a measure of corticospinal inhibition evaluated using transcranial magnetic stimulation (TMS), is inconsistent in literature. We envisioned that investigating CSP across muscles with varying degrees of weakness may be a reasonable approach to resolve inconsistencies and elucidate the relevance of corticospinal inhibition for upper extremity function following SCI. METHODS: We studied 27 adults with chronic C1-C8 SCI (age 48.8 ± 16.1 years, 3 females) and 16 able-bodied participants (age 33.2 ± 11.8 years, 9 females). CSP characteristics were assessed across biceps (muscle power = 3-5) and triceps (muscle power = 1-3) representing stronger and weaker muscles, respectively. We assessed functional abilities using the Capabilities of the Upper Extremity Test (CUE-T). RESULTS: Participants with chronic SCI had prolonged CSPs for biceps but delayed and diminished CSPs for triceps compared to able-bodied participants. Early-onset CSPs for biceps and longer, deeper CSPs for triceps correlated with better CUE-T scores. CONCLUSIONS: Corticospinal inhibition is pronounced for stronger biceps but diminished for weaker triceps muscle in SCI indicating innervation relative to the level of injury matters in the study of CSP. SIGNIFICANCE: Nevertheless, corticospinal inhibition or CSP holds relevance for upper extremity function following SCI.
Subject(s)
Neural Inhibition , Pyramidal Tracts , Spinal Cord Injuries , Transcranial Magnetic Stimulation , Upper Extremity , Humans , Female , Spinal Cord Injuries/physiopathology , Male , Adult , Middle Aged , Pyramidal Tracts/physiopathology , Upper Extremity/physiopathology , Transcranial Magnetic Stimulation/methods , Neural Inhibition/physiology , Muscle, Skeletal/physiopathology , Evoked Potentials, Motor/physiology , Cervical Cord/physiopathology , Cervical Cord/injuries , Young Adult , Cervical Vertebrae/physiopathology , Electromyography/methodsABSTRACT
Postural control requires effective sensory integration. People with Parkinson's disease (PD) are reported to have impaired visual and vestibular perception. While self-motion perception is a key aspect of locomotion, visual-vestibular integration has not been directly characterized in people with PD during gait. We compared the ability of people with PD and healthy older adults (OA) to integrate multi-sensory information during straight-line walking in response to visual and vestibular perturbations, using continuous translations of the visual surround and galvanic vestibular stimulation within a virtual reality environment. We measured their endpoint deviations from midline and changes in gait parameters. We found that people with PD deviated more than OA when walking in a dark environment but did not show differences in deviations when walking in a virtual room with visual information. With visual and vestibular perturbations, people with PD did not differ from OA in endpoint deviations nor variabilities. However, people with PD did not adopt a more cautious gait when GVS was applied in a virtual room, unlike OA. Overall, we showed that people with mild PD did not perform worse than OA but did show differences in gait patterns, suggesting that visual-vestibular integration is relatively preserved during gait in PD.
Subject(s)
Parkinson Disease , Humans , Aged , Parkinson Disease/complications , Walking/physiology , Gait/physiology , Locomotion , Postural Balance/physiologyABSTRACT
BACKGROUND: Transcranial ultrasound stimulation (TUS) is a novel non-invasive brain stimulation technique with high depth penetrance and spatial resolution. Theta-burst TUS (tbTUS) is a plasticity-inducing protocol which increases motor cortical excitability for up to 30 min following 80s of sonication. While this protocol may have therapeutic potential for the treatment of psychiatric and neurological disorders, the mechanisms of action of TUS remain unclear. OBJECTIVE: We conducted the first pharmacological study to examine the mechanisms of TUS in human primary motor cortex. By administering brain-active drugs with known mechanisms of action, we aimed to elucidate the mechanisms of tbTUS. METHODS: Fourteen healthy subjects participated in a within-subjects randomized, double-blind, cross-over study with five visits. At each visit, one of four study drugs (carbamazepine - Na+ channel blocker, nimodipine - L-type Ca2+ channel blocker, lorazepam - positive allosteric modulator of gamma-aminobutyric acid (GABA) type A receptor, dextromethorphan - N-methyl-d-aspartate receptor antagonist) or placebo was administered in random order, followed by tbTUS. RESULTS: The plasticity effects of tbTUS on motor cortex excitability measured by motor-evoked potential amplitudes elicited by transcranial magnetic stimulation were reduced by all study drugs compared to placebo. CONCLUSION: tbTUS may induce NMDA-dependent synaptic plasticity since the effects are blocked by increased GABAA receptor activities and voltage-gated Na+ and Ca2+ channels blockers. These results are consistent with the hypotheses that tbTUS induced long-term potentiation-like mechanisms and that TUS involves activation of mechanosensitive Na+ and Ca2+ channels. Alternatively, non-specific pharmacologically induced changes in excitatory/inhibitory balance might have interfered with the effects of tbTUS.
Subject(s)
Motor Cortex , Humans , Motor Cortex/physiology , Cross-Over Studies , Neuronal Plasticity/physiology , Long-Term Potentiation/physiology , Evoked Potentials, Motor/physiology , Transcranial Magnetic Stimulation/methodsABSTRACT
In this research, a non-fragile synchronization of bidirectional association memory (BAM) delayed neural networks is taken into consideration. The controller gain fluctuation seems in a very random manner, that obeys sure Bernoulli distributed noise sequences. Delay dependent criteria are derived to confirm the asymptotic stability of the BAM delayed neural networks. The non-fragile controller are often obtained by determination a collection of linear matrix inequalities (LMIs). A simulation example is used to demonstrate the efficiency of the developed control.
ABSTRACT
It is often difficult to obtain valid estimates of comparative treatment effectiveness and safety owing to differences across patient populations taking different medications in the real world. One approach for assessing comparability between treatment groups in effectiveness studies is to use negative control outcomes (NCOs). NCOs share similar sources of bias with the primary outcomes but have no plausible causal relationship to the treatment of interest. Observing differences in the risk of NCOs thus provides evidence for residual confounding between groups. This retrospective study assessed the comparability of postmenopausal women, treated with osteoporosis medications with various mechanisms of action such as denosumab (receptor activator of nuclear factor κB ligand [RANKL] inhibitor), zoledronic acid (bisphosphonate derivative), or oral bisphosphonates including alendronate. Administrative claims data were extracted from the US Centers for Medicare and Medicaid Services' Chronic Condition Warehouse database (May 2010-December 2016). Propensity scores were used to match denosumab patients 1:1 to comparators. Four nonfracture NCOs and three early fracture NCOs (before substantial biologic effects of treatment would be expected) were assessed over 1-year and 3-month follow-up periods, respectively. According to comparability decision rules established a priori, patients initiating denosumab were comparable to those initiating zoledronic acid or alendronate, irrespective of prior osteoporosis treatment experience. Among new users, new switchers, and in the historical fracture subgroup, no meaningful differences were observed in the cumulative incidence of the seven NCOs comparing denosumab to zoledronic acid. This empirical examination can assist in the selection of appropriate comparator groups for future comparability research using real-world data. © 2023 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
Subject(s)
Bone Density Conservation Agents , Fractures, Bone , Osteoporosis, Postmenopausal , Osteoporosis , Humans , Female , Aged , United States , Bone Density Conservation Agents/adverse effects , Zoledronic Acid/therapeutic use , Alendronate/adverse effects , Denosumab/adverse effects , Retrospective Studies , Medicare , Diphosphonates/adverse effects , Osteoporosis/drug therapy , Fractures, Bone/drug therapy , Osteoporosis, Postmenopausal/drug therapyABSTRACT
Functional movement disorders (FMD) are a subtype of functional neurological disorders which involve abnormal movements and include multiple phenomenologies. There is a growing interest in the mechanism, diagnosis, and treatment of these disorders. Most of the current therapeutic approaches rely on psychotherapy and physiotherapy conducted by a multidisciplinary team. Although this approach has shown good results in some cases, FMD cause a great burden on the health system and other treatment strategies are urgently needed. In this review, we summarize past studies that have applied non-invasive neurostimulation techniques, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS) and peripheral nerve stimulation as a treatment for FMD. There is an increasing number of studies related to TMS including randomized controlled trials; however, the protocols amongst studies are not standardized. There is only preliminary evidence for the efficacy of non-invasive neuromodulation in reducing FMD symptoms, and further studies are needed. There is insufficient evidence to allow implementation of these techniques in clinical practice.
ABSTRACT
Background: Access to high-quality neurosurgery online learning is limited in low- and middle-income countries, and Iraq is part of this category. The need for collaboration and connection of people worldwide to exchange ideas and experiences in neurosurgery is a challenge. Surgical Neurology International® (SNI)/SNI Digital stimulated the establishment of the joint effort to bring the discussion about the best experiences in neurosurgery from the United States and Iraq together in an internet meeting format. Methods: An online survey was formulated and distributed to the attendees of the SNI-Baghdad neurosurgery meetings. The survey investigates the last 14 consecutive meetings for the period May/2021-April/2022. The online survey was designed utilizing Google Forms. The survey outline includes demographics, general aspects of the meetings, research aspects, surgical anatomy, neuroradiology, and capacity-building aspects. All these sections of the survey used a 5-point Likert scale. Results: The total number of participants was 84 out of 115 sent, with a response rate of 73.1%. The participants were diverse as they ranged from medical students to attending neurosurgeons. The male-to-female ratio was 1:1. Most attendees were from Baghdad (n = 66 [77.6%]) and the highest number of the responders was from the University of Baghdad (n = 46 [54.1%]). Conclusion: The targeted online collaborative meetings, SNI-Baghdad neurosurgery meeting as an example, give an insight into the effectiveness of such methods in providing a mutually beneficial educational experience between people of different parts of the world, as assessed by a survey initiated and performed by the attendees.
ABSTRACT
Comprehensive assessment following traumatic spinal cord injury (SCI) is needed to improve prognostication, advance the understanding of the neurophysiology and better targeting of clinical interventions. The International Standards for Neurological Classification of Spinal Cord Injury is the most common clinical examination recommended for use after a SCI. In addition, there are over 30 clinical assessment tools spanning across different domains of the International Classification of Functioning, Disability, and Health that have been validated and recommended for use in SCI. Most of these tools are subjective in nature, have limited value in predicting neurologic recovery, and do not provide insights into neurophysiological mechanisms. Transcranial magnetic stimulation (TMS) is a non-invasive neurophysiology technique that can supplement the clinical assessment in the domain of body structure and function during acute and chronic stages of SCI. TMS offers a better insight into neurophysiology and help in better detection of residual corticomotor connectivity following SCI compared to clinical assessment alone. TMS-based motor evoked potential and silent period duration allow study of excitatory and inhibitory mechanisms following SCI. Changes in muscle representations in form of displacement of TMS-based motor map center of gravity or changes in the map area can capture neuroplastic changes resulting from SCI or following rehabilitation. Paired-pulse TMS measures help understand the compensatory reorganization of the cortical circuits following SCI. In combination with peripheral stimulation, TMS can be used to study central motor conduction time and modulation of spinal reflexes, which can be used for advanced diagnostic and treatment purposes. To strengthen the utility of TMS in SCI assessment, future studies will need to standardize the assessment protocols, address population-specific concerns, and establish the psychometric properties of TMS-based measurements in the SCI population.
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Humans have traditionally found it simple to identify emotions from facial expressions, but it is far more difficult for a computer system to do the same. The social signal processing subfield of emotion recognition from facial expression is used in a wide range of contexts, particularly for human-computer interaction. Automatic emotion recognition has been the subject of numerous studies, most of which use a machine learning methodology. The recognition of simple emotions like anger, happiness, contempt, fear, sadness, and surprise, however, continues to be a difficult topic in computer vision. Deep learning has recently drawn increased attention as a solution to a variety of practical issues, including emotion recognition. In this study, we improved the convolutional neural network technique to identify 7 fundamental emotions and evaluated several preprocessing techniques to demonstrate how they affected the CNN performance. This research focuses on improving facial features and expressions based on emotional recognition. By identifying or recognising facial expressions that elicit human responses, it is possible for computers to make more accurate predictions about a person's mental state and to provide more tailored responses. As a result, we examine how a deep learning technique that employs a convolutional neural network might improve the detection of emotions based on facial features (CNN). Multiple facial expressions are included in our dataset, which consists of about 32,298 photos for testing and training. The preprocessing system aids in removing noise from the input image, and the pretraining phase aids in revealing face detection after noise removal, including feature extraction. As a result, the existing paper generates the classification of multiple facial reactions like the seven emotions of the facial acting coding system (FACS) without using the optimization technique, but our proposed paper reveals the same seven emotions of the facial acting coding system.
Subject(s)
Deep Learning , Facial Recognition , Humans , Algorithms , Emotions/physiology , Facial ExpressionABSTRACT
People are actively expressing their views and opinions via the use of visual pictures and text captions on social media platforms, rather than just publishing them in plain text as a consequence of technical improvements in this field. With the advent of visual media such as images, videos, and GIFs, research on the subject of sentiment analysis has expanded to encompass the study of social interaction and opinion prediction via the use of visuals. Researchers have focused their efforts on understanding social interaction and opinion prediction via the use of images, such as photographs, films, and animated GIFs (graphics interchange formats). The results of various individual studies have resulted in important advancements being achieved in the disciplines of text sentiment analysis and image sentiment analysis. It is recommended that future studies investigate the combination of picture sentiment analysis and text captions in more depth, and further research is necessary for this field. An intermodal analysis technique known as deep learning-based intermodal (DLBI) analysis is discussed in this suggested study, which may be used to show the link between words and pictures in a variety of scenarios. It is feasible to gather opinion information in numerical vector form by using the VGG network. Afterward, the information is transformed into a mapping procedure. It is necessary to predict future views based on the information vectors that have been obtained thus far, and this is accomplished through the use of active deep learning. A series of simulation tests are being conducted to put the proposed mode of operation to the test. When we look at the findings of this research, it is possible to infer that the model outperforms and delivers a better solution with more accuracy and precision, as well as reduced latency and an error rate, when compared to the alternative model (the choice).
Subject(s)
Deep Learning , Social Media , Data Collection/methods , Humans , Sentiment AnalysisABSTRACT
Background: Approximately two-thirds of stroke survivors experience chronic upper limb paresis, and of them, 50% experience severe paresis. Treatment options for severely impaired survivors are often limited. Rehabilitation involves intensively engaging the paretic upper limb, and disincentivizing use of the non-paretic upper limb, with the goal to increase excitability of the ipsilesional primary motor cortex (iM1) and suppress excitability of the undamaged (contralesional) motor cortices, presumed to have an inhibitory effect on iM1. Accordingly, brain stimulation approaches, such as repetitive transcranial magnetic stimulation (rTMS), are also given to excite iM1 and/or suppress contralesional motor cortices. But such approaches aimed at ultimately increasing iM1 excitability yield limited functional benefit in severely impaired survivors who lack sufficient ipsilesional substrate. Aim: Here, we test the premise that combining Contralaterally Controlled Functional Electrical Stimulation (CCFES), a rehabilitation technique that engages the non-paretic upper limb in delivery of neuromuscular electrical stimulation to the paretic upper limb, and a new rTMS approach that excites intact, contralesional higher motor cortices (cHMC), may have more favorable effect on paretic upper limb function in severely impaired survivors based on recruitment of spared, transcallosal and (alternate) ipsilateral substrate. Methods: In a prospective, double-blind, placebo-controlled RCT, 72 chronic stroke survivors with severe distal hand impairment receive CCFES plus cHMC rTMS, iM1 rTMS, or sham rTMS, 2X/wk for 12wks. Measures of upper limb motor impairment (Upper Extremity Fugl Meyer, UEFM), functional ability (Wolf Motor-Function Test, WMFT) and perceived disability are collected at 0, 6, 12 (end-of-treatment), 24, and 36 wks (follow-up). TMS is performed at 0, 12 (end-of-treatment), and 36 wks (follow-up) to evaluate inter-hemispheric and ipsilateral mechanisms. Influence of baseline severity is also characterized with imaging. Conclusions: Targeting of spared neural substrates and rehabilitation which engages the unimpaired limb in movement of the impaired limb may serve as a suitable combinatorial treatment option for severely impaired stroke survivors. ClinicalTrials No: NCT03870672.
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STUDY DESIGN: A multisite, randomized, controlled, double-blinded phase I/II clinical trial. OBJECTIVE: The purpose of this clinical trial is to evaluate the safety, feasibility and efficacy of pairing noninvasive transcranial direct current stimulation (tDCS) with rehabilitation to promote paretic upper extremity recovery and functional independence in persons living with chronic cervical spinal cord injury (SCI). SETTING: Four-site trial conducted across Cleveland Clinic, Louis Stokes Veterans Affairs Medical Center of Cleveland and MetroHealth Rehabilitation Rehabilitation Institute of Ohio, and Kessler Foundation of New Jersey. METHODS: Forty-four adults (age ≥18 years) with tetraplegia following cervical SCI that occurred ≥1-year ago will participate. Participants will be randomly assigned to receive anodal tDCS or sham tDCS given in combination with upper extremity rehabilitation for 15 sessions each over 3-5 weeks. Assessments will be made twice at baseline separated by at least a 3-week interval, once at end-of-intervention, and once at 3-month follow-up. PRIMARY OUTCOME MEASURE(S): Primary outcome measure is upper extremity motor impairment assessed using the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) scale. Functional abilities will be assessed using Capabilities of Upper Extremity-Test (CUE-T), while functional independence and participation restrictions will be evaluated using the self-care domain of Spinal Cord Independent Measure (SCIM), and Canadian Occupational Performance Measure (COPM). SECONDARY OUTCOME MEASURES: Treatment-associated change in corticospinal excitability and output will also be studied using transcranial magnetic stimulation (TMS) and safety (reports of adverse events) and feasibility (attrition, adherence etc.) will also be evaluated. TRIAL REGISTRATION: ClincalTrials.gov identifier NCT03892746. This clinical trial is being performed at four sites within the United States: Cleveland Clinic (lead site), Louis Stokes Cleveland Veterans Affairs Medical Center (VAMC) and MetroHealth Rehabilitation Institute in Ohio, and Kessler Foundation in New Jersey. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.
Subject(s)
Spinal Cord Injuries , Transcranial Direct Current Stimulation , Adolescent , Adult , Canada , Clinical Trials, Phase I as Topic , Humans , Multicenter Studies as Topic , Quadriplegia , Randomized Controlled Trials as Topic , Recovery of Function , Transcranial Direct Current Stimulation/adverse effects , Transcranial Direct Current Stimulation/methods , Treatment Outcome , Upper ExtremityABSTRACT
PURPOSE: To evaluate the follow up and treatment outcome of central serous chorioretinopathy (CSCR) based on the new multimodal imaging-based classification and identify the predictors for anatomic and visual outcome. METHODS: Retrospective, multicentric study on 95 eyes diagnosed with CSCR and a follow up of at least 12 months were included. Eyes with macular neovascularization, atypical CSCR or any other disease were excluded. RESULTS: At the baseline, observation was advised to 70% eyes with simple CSCR whereas photodynamic therapy (PDT) was performed in 49% eyes with complex CSCR. Over the follow up, decrease in CMT was significantly higher in simple CSCR as compared to complex CSCR (P = 0.008) and the recurrences were significantly more in eyes with lower CMT at baseline (P = 0.0002). Median time of resolution of SRF was 3 months and 6 months in simple and complex CSCR respectively (P = 0.09). For the 12 months follow up, the median fluid free period was greater (P = 0.03) while number of interventions performed was lesser in eyes with simple CSCR as compared to complex CSCR (P = 0.006). Multiple regression analysis showed baseline best corrected visual acuity (BCVA) and baseline persistent SRF to be significantly predictive of BCVA and persistent SRF at 12 months (P < 0.0001, 0.04) respectively. CONCLUSIONS: Complex CSCR more often required PDT, was associated with shorter fluid free interval and longer time for SRF resolution. Baseline BCVA and persistent SRF were predictive of final visual and anatomical outcome. The new multimodal imaging based classification is helpful in establishing objective criteria for planning treatment approaches for CSCR.
Subject(s)
Central Serous Chorioretinopathy , Photochemotherapy , Central Serous Chorioretinopathy/diagnostic imaging , Central Serous Chorioretinopathy/drug therapy , Chronic Disease , Fluorescein Angiography , Humans , Multimodal Imaging , Photochemotherapy/methods , Retrospective Studies , Tomography, Optical Coherence , Treatment Outcome , Visual AcuityABSTRACT
OBJECTIVE: To evaluate visual acuity (VA) and factors influencing VA using new multimodal imaging-based classification of central serous chorioretinopathy (CSCR). METHODS: Retrospective, observational and cross-sectional study on 229 naïve eyes diagnosed as CSCR with available baseline data and multimodal imaging. Each case was classified into (i) simple/complex/atypical; (ii) primary/recurrent/resolved; (iii) persistent or not; (iv) outer retinal atrophy(ORA) present/absent; (v) foveal involvement present/absent; and (vi) macular neovascularization(MNV) present/absent. Best corrected visual acuity (BCVA) was correlated to the classification as well as every parameter of the classification. RESULTS: Median BCVA was 0.18 logMAR [95% Confidence Interval (CI)0.16-0.18] with median duration of complaints of one month (95% CI,6.14-13.0 months). Age of the patient (r = -0.24, p = 0.002) and duration of the disease (r = -0.32, p < 0.001) correlated significantly with BCVA. Logistic regression model showed that older age [odds ratio (OR) = 0.96, p = 0.05], female gender (OR = 2.45, p = 0.046), presence of ORA(OR = 0.34, p = 0.012),and foveal involvement(OR = 0.18, p = 0.007) were statistically significantly associated with poorer BCVA. Eyes classified as complex, persistent CSCR, with ORA or foveal involvement demonstrated lower BCVA compared to those with simple, non-persistent CSCR, without ORA or without foveal involvement (p < 0.05). Eyes with complex CSCR (p < 0.001), atypical CSCR(p = 0.025), persistent subretinal fluid (SRF) (p = 0.001) and those with ORA (p < 0.001) demonstrated a trend towards severe visual loss. Prevalence of persistent SRF, recurrent episodes and ORA was significantly higher among eyes with complex CSCR (p < 0.001) while there was no difference in prevalence of resolved cases (p = 0.07), foveal involvement (p = 0.28) and MNV (p = 0.45) between simple and complex cases. CONCLUSION: There is a strong correlation between VA and foveal involvement and ORA using the new classification. Thus, the objective parameters of the classification can be incorporated in establishing the treatment guidelines for CSCR.
Subject(s)
Central Serous Chorioretinopathy , Central Serous Chorioretinopathy/complications , Central Serous Chorioretinopathy/diagnosis , Cross-Sectional Studies , Female , Fluorescein Angiography , Humans , Male , Multimodal Imaging , Retrospective Studies , Tomography, Optical Coherence/methods , Visual AcuityABSTRACT
Sildenafil citrate, a selective oral phosphodiesterase 5 inhibitor, is a widely used drug for erectile dysfunction that acts by elevating cGMP levels and causing smooth muscle relaxation. It also has 10% activity against PDE6, a key enzyme in phototransduction cascade in the retina. Recent ocular imaging developments have further revealed the influence of sildenafil on ocular hemodynamics, particularly choroidal perfusion. Choroidal thickness is increased, and choroidal perfusion is also enhanced by autoregulatory mechanisms that are further dependent on age and microvascular abnormalities. Studies demonstrating high intraocular pressure via a "parallel pathway" from increased choroidal volume and blood flow to the ciliary body have challenged previous concepts. Another new observation is the effect of sildenafil on bipolar cells and cyclic-nucleotide gated channels. We discuss potential deleterious effects (central serous chorioretinopathy, glaucoma, ischemic optic neuropathy, and risks to recessive carriers of retinitis pigmentosa), potential beneficial effects (ameliorate choroidal ischemia, prevent thickening of Bruch membrane, and promote recovery of the ellipsoid zone) in macular degeneration, as well as potential drug interactions of sildenafil.