Feasibility and Safety of a Home-based Electroencephalogram Neurofeedback Intervention to Reduce Chronic Neuropathic Pain: A Cohort Clinical Trial.

Objective: To evaluate the feasibility, safety, and potential health benefits of an 8-week home-based neurofeedback intervention. Design: Single-group preliminary study. Setting: Community-based. Participants: Nine community dwelling adults with chronic neuropathic pain, 6 women and 3 men, with an average age of 51.9 years (range, 19-78 years) and with a 7-day average minimum pain score of 4 of 10 on the visual analog pain scale. Interventions: A minimum of 5 neurofeedback sessions per week (40min/session) for 8 consecutive weeks was undertaken with a 12-week follow-up baseline electroencephalography recording period. Main Outcome Measures: Primary feasibility outcomes: accessibility, tolerability, safety (adverse events and resolution), and human and information technology (IT) resources required. Secondary outcomes: pain, sensitization, catastrophization, anxiety, depression, sleep, health-related quality of life, electroencephalographic activity, and simple participant feedback. Results: Of the 23 people screened, 11 were eligible for recruitment. One withdrew and another completed insufficient sessions for analysis, which resulted in 9 datasets analyzed. Three participants withdrew from the follow-up baselines, leaving 6 who completed the entire trial protocol. Thirteen adverse events were recorded and resolved: 1 was treatment-related, 4 were equipment-related, and 8 were administrative-related (eg, courier communication issues). The human and IT resources necessary for trial implementation were identified. There were also significant improvements in pain levels, depression, and anxiety. Six of 9 participants perceived minimal improvement or no change in symptoms after the trial, and 5 of 9 participants were satisfied with the treatment received. Conclusions: It is feasible and safe to conduct a home-based trial of a neurofeedback intervention for people with chronic neuropathic pain, when the human and IT resources are provided and relevant governance processes are followed. Improvements in secondary outcomes merit investigation with a randomized controlled trial.

Living With Spasticity During the COVID-19 Pandemic: A Qualitative Study of Patient, Carer and Physician Experiences.

BACKGROUND: Approximately 4.4 million people in England (8% of the total population) are living with a long-term neurological condition. Within this group of vulnerable individuals, there will be individuals living with severe spasticity that requires regular outpatient treatment with botulinum toxin injection. The closure of outpatient spasticity services during the pandemic impacted individuals who required spasticity treatment and their carers, as well as the specialist clinicians responsible for service delivery. OBJECTIVES: We aimed to gain insight into the experiences of individuals living with spasticity, their carers and a clinical spasticity service lead during the pandemic, and to reflect on potential learning for the future. METHODS: A qualitative study was designed using semi-structured interviews conducted by telephone. Participants comprised patients living with a long-term neurological condition who attended outpatient spasticity clinics before the start of the pandemic in England, primary carers who accompanied patients attending these clinics and a clinical spasticity service lead. Data were audio recorded, transcribed, anonymised and coded. Data analysis utilised the One Sheet of Paper thematic approach to identify themes, which were discussed and analysed by the interdisciplinary research team and two patient and carer participants. RESULTS: Out of the 11 participants recruited, aged 36-77 years, seven comprised people living with spasticity related to a long-term neurological condition, three were carers and one was a clinical spasticity service lead. Six participants were male and five were female. Among the participants, four were stroke survivors, two were living with spinal cord injury and one was living with multiple sclerosis. Analysis revealed six major themes: experience of living with spasticity during the pandemic; impact of the pandemic on patient, carer and clinician health; access to and experience of outpatient clinic appointments; coping strategies during the pandemic; system improvements; and learning from the pandemic period. CONCLUSION: These findings contribute research knowledge to a very limited research knowledge base and suggest that there is scope for improving system and service delivery through the allocation of research funding to senior clinicians working in this specialist area.

Effect of Skin Pigmentation and Finger Choice on Accuracy of Oxygen Saturation Measurement in an IoT-Based Pulse Oximeter.

Pulse oximeters are widely used in hospitals and homes for measurement of blood oxygen saturation level (SpO2) and heart rate (HR). Concern has been raised regarding a possible bias in obtaining pulse oximeter measurements from different fingertips and the potential effect of skin pigmentation (white, brown, and dark). In this study, we obtained 600 SpO2 measurements from 20 volunteers using three UK NHS-approved commercial pulse oximeters alongside our custom-developed sensor, and used the Munsell colour system (5YR and 7.5YR cards) to classify the participants' skin pigmentation into three distinct categories (white, brown, and dark). The statistical analysis using ANOVA post hoc tests (Bonferroni correction), a Bland-Altman plot, and a correlation test were then carried out to determine if there was clinical significance in measuring the SpO2 from different fingertips and to highlight if skin pigmentation affects the accuracy of SpO2 measurement. The results indicate that although the three commercial pulse oximeters had different means and standard deviations, these differences had no clinical significance.

A systematic review of vestibular stimulation in post-stroke visual neglect.

Unilateral visual neglect is a condition that negatively impacts the lives of many stroke survivors. Studies have investigated different forms of vestibular stimulation as a potential therapy, but evidence is yet to be systematically reviewed. We therefore reviewed the effects of vestibular stimulation on outcomes of neglect and activities of daily living (ADL) for people with visual neglect. We searched relevant databases up until September 2022. Eligible articles included any form of vestibular stimulation, study design, or control condition. Included participants were 18 years or older, presenting with neglect following a haemorrhagic or ischaemic stroke. Relevant outcomes were clinically validated measures of neglect and ADL. Cochrane risk of bias tools were used to assess study quality. Meta-analyses and narrative methods were used to synthesize the data. Our search returned 17 relevant studies comprising 180 participants. Meta-analyses showed no difference between galvanic vestibular stimulation and sham conditions on outcomes, whereas caloric vestibular stimulation led to improvement compared to pre-stimulation scores. Narrative syntheses showed mixed results. Clinical and methodological heterogeneity was found both within and between studies. Overall, results were inconsistent regarding the effects of vestibular stimulation as a treatment for neglect. Further trials are warranted but require more careful methodological planning.

Is it time for a paradigmatic shift in relation to healthcare in the UK? A reflection.

CONTEXT: Conflict is a driver of change and unions representing professional groups across the National Health Service (NHS) are currently engaged in direct conflict with the government. For the first time in the history of the NHS, healthcare professionals have taken industrial strike action. Junior doctors and consultant physicians are currently engaged in their respective union ballots and indicative poll surveys regarding potential strike action in the future. In the wake of such widespread industrial action, we have taken time to think deeply about the confronting challenges and issues and offer this reflection as an opportunity to redefine and re-frame an unsustainable healthcare system into one that is the best it can be in terms of fit for purpose. INSIGHTS AND RESOURCE SIGNPOSTING: We present the current context with a reflective framework table focused on 'What do we do well? What is not done so well? What could some possible ideas and solutions be? and How could this change be supported?'We outline how a culture of well-being could be strategically and operationally introduced into the NHS workplace using research-based evidence and practical tools supported by expert guidance.

Co-creating system-wide improvement for people with traumatic brain injury across one integrated care system in the United Kingdom to initiate a transformation journey through co-production.

BACKGROUND AND OBJECTIVE: There is a need for better integration of services across communities and sectors for people living with traumatic brain injury (TBI) to meet their complex needs. Building on insights gained from earlier pilot work, here we report the outcomes of a participatory workshop that sought to better understand the challenges, barriers and opportunities that currently exist within the care pathway for survivors of TBI. METHODS: A diverse range of stakeholders from the acute and rehabilitation care pathway and the health and social care system were invited to participate in a 3-h workshop. The participants worked in four mixed subgroups using practice development methodology, which promotes person-centred, inclusive and participatory action. RESULTS: Thematic analysis identified shared purposes and values that were used to produce a detailed implementation and impact framework for application at both the level of the care interface and the overarching integrated care system. A variety of enablers were identified that related to collective values and behaviours, case management, team leadership and integrated team working, workforce capability, evidence-based practice and resourcing. The clinical, economic, cultural and social outcomes associated with these enablers were also identified, and included patient safety, independence and well-being, reduced waiting times, re-admission rates, staff retention and professional development. CONCLUSION: The co-produced recommendations made within the implementation and impact framework described here provide a means by which the culture and delivery of health and social care services can be better tailored to meet the needs of people living with TBI. We believe that the recommendations will help shape the formation of new services as well as the development of existing ones. PATIENT OR PUBLIC CONTRIBUTION: Patient and public involvement have been established over a 10-year history of relationship building through a joint forum and events involving three charities representing people with TBI, carers, family members, clinicians, service users, researchers and commissioners, culminating in a politically supported event that identified concerns about the needs of people following TBI. These relationships formed the foundation for the interactive workshop, the focus of this publication.

Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III).

OBJECTIVE: To evaluate the feasibility, usability, safety, and potential health benefits of using an exoskeleton device for rehabilitation of people living with multiple sclerosis. DESIGN: Single-group preliminary study. SUBJECTS: Eleven adults living with multiple sclerosis, with Expanded Disability Status Scores that ranged from 6 to 7.5 (mean age (standard deviation; SD) 54.2 (11.8) years), were recruited. METHODS: Individual participants undertook a balance rehabilitation exercise programme using the Rex Rehab robotic exoskeleton device. Each participant undertook 4 × 45-60 min supervised, balance exercise sessions. Primary outcomes were: (i) the number of participants who completed the trial protocol safely, and (ii) the number and nature of adverse events reported. Secondary outcomes were: mobility; balance; spasticity; sleep; functional independence; quality of life; and device satisfaction. RESULTS: Ten out of 11 participants completed the trial protocol safely. Four adverse events were recorded (1 serious), all of which were deemed unrelated to the trial. Secondary outcomes showed allied improvements in balance, joint mobility, spasticity and quality of life. All participants found the device acceptable to use. CONCLUSION: These results suggest that it is feasible and safe to use the Rex Rehab exoskeleton device to assist with balance rehabilitation for people living with multiple sclerosis.

Key demographics and psychological skills associated with adjustment to progressive Multiple Sclerosis early in the diagnosis.

Background/purpose: Being diagnosed with a progressive type of multiple sclerosis (MS) has been associated with worse psychological outcomes compared to relapsing-remitting type. Previous studies of adjustment to MS have primarily focused on relapsing-remitting type MS. The present study aims to examine psychological adjustment for people newly diagnosed with progressive multiple sclerosis. Methods: This was a multicenter cross-sectional survey of 189 people newly diagnosed with progressive MS. A composite measure of psychological adjustment was created from questionnaires measuring psychological distress, positive affect, perceived-stress, life satisfaction and self-concept. Predictor variables included coping strategies, social support, relationship with partner, psychological vulnerability, MS-related beliefs, and responses to symptoms. Data were analysed using a regularised regression model to indicate which group of all variables are associated with adjustment. Results: People who were older (b = 0.17(0.07), p = 0.02), in employment (b = 0.40 (0.17), p = 0.01), and with lower illness severity (b = -0.24 (0.08), p = 0.001) showed better adjustment. Based on a Lasso regression, the most important psychological and demographic variables associated with lower adjustment (out-of-sample cross-validation R 2 = 62.6%) were lower MS self-efficacy and higher avoidance, cognitive vulnerability, embarrassment avoidance, conflict, helplessness, and secondary progressive MS type. Conclusions and implications: Helping newly diagnosed people to find ways to tolerate anxiety-causing situations by encouraging acceptance may help people adjust to progressive MS by lowering their avoidance. Further, building confidence in managing the illness and addressing relationship issues are key focus areas in psychological interventions for people with progressive multiple sclerosis.

Ethical issues and dilemmas in spinal cord injury rehabilitation in the developing world: a mixed-method study.

STUDY DESIGN: Mixed-method study (small group discussions and online literature search). OBJECTIVES: Identify the ethical issues and dilemmas faced by rehabilitation professionals involved in the service delivery to the persons with spinal cord injury (SCI) in the low income and lower-middle-income countries (LIC/LMIC) located in Asia. SETTING: Small group discussions in three biomedical conferences in Dhaka, Bangladesh and Kualalampur, Malaysia. METHODS: Three small group discussions (30-45 min each) were held during three international conferences in 2019. The conferences brought together experts in the fields of neurology, rehabilitation, neurorehabilitation, and bioethics. A summary of SCI practice points and dilemmas were documented including goals of care, duties of rehabilitation professionals, health care worker-patient relationships, roles, and expectations of family members at different care settings. RESULTS: There is a paucity of literature on this topic. The application of the principles of contemporary bioethics in the pluralistic societies of LIC/LMIC can be challenging. The ethical dilemmas faced by rehabilitation professionals working in LIC/LMIC are diverse and different from those reported from the Western and developed countries. Ethical issues and dilemmas identified were understanding patient autonomy in decision making, lack of insurance for SCI rehabilitation, financial challenges, challenges of providing emerging technology in SCI rehabilitation and SCI rehabilitation during disasters. CONCLUSIONS: We have summarized the possible ethical issues and dilemmas which rehabilitation professionals in LIC/LMIC may encounter during delivery of SCI rehabilitation services. We hope it generates a discussion on an often-neglected aspect of SCI care in the LIC/LMIC and helps identify the complexities of ethical dilemmas unique to persons with SCI living in a developing country.

Prevalence of Long COVID symptoms in Bangladesh: a prospective Inception Cohort Study of COVID-19 survivors.

BACKGROUND: The objective of this study was to identify the prevalence of long COVID symptoms in a large cohort of people living with and affected by long COVID and identify any potential associated risk factors. METHODS: A prospective survey was undertaken of an inception cohort of confirmed people living with and affected by long COVID (aged 18-87 years). 14392 participants were recruited from 24 testing facilities across Bangladesh between June and November 2020. All participants had a previously confirmed positive COVID-19 diagnosis, and reported persistent symptoms and difficulties in performing daily activities. Participants who consented were contacted by face-to-face interview, and were interviewed regarding long COVID, and restriction of activities of daily living using post COVID-19 functional status scale. Cardiorespiratory parameters measured at rest (heart rate, systolic blood pressure, diastolic blood pressure, oxygen saturation levels, maximal oxygen consumption, inspiratory and expiratory lung volume) were also measured. RESULTS: Among 2198 participants, the prevalence of long COVID symptoms at 12 weeks was 16.1%. Overall, eight long COVID symptoms were identified and in descending order of prominence are: fatigue, pain, dyspnoea, cough, anosmia, appetite loss, headache and chest pain. People living with and affected by long COVID experienced between 1 and 8 long COVID symptoms with an overall duration period of 21.8±5.2 weeks. Structural equation modelling predicted the length of long COVID to be related to younger age, female gender, rural residence, prior functional limitation and smoking. CONCLUSION: In this cohort, at 31 weeks post diagnosis, the prevalence of long COVID symptoms was 16.1%. The risk factors identified for presence and longer length of long COVID symptoms warrant further research and consideration to support public health initiatives.

Knowledge, Attitudes, Behavioural Practises, and Psychological Impact Relating to COVID-19 Among People Living With Spinal Cord Injury During In-Patient Rehabilitation in Bangladesh.

AIM: The aim of this research is to focus on gaining an insight into the knowledge, attitudes, behavioural practises (KAP), and psychological impact relating to COVID-19 among the people living with spinal cord injury receiving in-patient rehabilitation. METHODS: A prospective, cross-sectional survey of people with SCI (N = 207), who were in active in-patient rehabilitation from two tertiary SCI Rehabilitation Centres in Bangladesh. Data were collected via face-to-face interviews, after voluntary consent, using a pretested, language validated questionnaire on Knowledge, Attitude and Behavioural practises (KAP) and the Depression, Anxiety, Stress Scale (DASS-21). Ethical approval and trial registration were obtained prospectively. RESULTS: A total of 207 people with SCI responded, among which 87% were men and 13% were women, with a mean age of 34.18 ± 12.9 years. Within the sample group, people living with tetraplegia comprised 33.8%, and people living with paraplegia comprised 66.2%. Overall, 63.8% of the participants were diagnosed with an SCI categorised as ASIA-A. Overall, the "knowledge score" was 8.59 ± 2.3 out of 12, "depression" was 11.18 ± 8, "anxiety" was 7.72 ± 5.1, and "stress" was 9.32 ± 6.7 from a total of 21 scores each category. The strong correlation was between knowledge, DASS scores, and age (p < 0.05). In addition, there was a strong correlation between knowledge, gender (p < 0.05) and education (p < 0.01). Binary logistic regression found a stronger association of knowledge and DASS scores with gender, young age, illiteracy (p < 0.01), and rural residence (p < 0.05). A positive relationship was found between depression and anxiety scores (p < 0.01) and a moderate positive relationship was found between depression and stress scores (p < 0.01). A positive attitude was reported by the majority of participants (p < 0.05). In terms of behavioural practises, participants reported both self and caregiver had followed health advice with regard to consulting health professionals (65.7%), implementing isolation (63.8%), taking droplet precaution care (87.4%), and hygiene care (90.3%). CONCLUSION: Participants in this study reported high levels of knowledge, adoption of positive attitudes, and the practise of positive health advisory behaviours related to COVID-19 prevention procedures. However, high levels of depression, anxiety, and stress were also reported. Overall, women and younger participants were more likely to have high KAP, whereas those living in rural areas and with literacy challenges were less likely to report high knowledge scores.

BCI controlled robotic arm as assistance to the rehabilitation of neurologically disabled patients.

PURPOSE: Brain-computer interface (BCI)-controlled assistive robotic systems have been developed with increasing success with the aim to rehabilitation of patients after brain injury to increase independence and quality of life. While such systems may use surgically implanted invasive sensors, non-invasive alternatives can be better suited due to the ease of use, reduced cost, improvements in accuracy and reliability with the advancement of the technology and practicality of use. The consumer-grade BCI devices are often capable of integrating multiple types of signals, including Electroencephalogram (EEG) and Electromyogram (EMG) signals. MATERIALS AND METHODS: This paper summarizes the development of a portable and cost-efficient BCI-controlled assistive technology using a non-invasive BCI headset "OpenBCI" and an open source robotic arm, U-Arm, to accomplish tasks related to rehabilitation, such as access to resources, adaptability or home use. The resulting system used a combination of EEG and EMG sensor readings to control the arm. To avoid risks of injury while the device is being used in clinical settings, appropriate measures were incorporated into the software control of the arm. A short survey was used following the system usability scale (SUS), to measure the usability of the technology to be trialed in clinical settings. RESULTS: From the experimental results, it was found that EMG is a very reliable method for assistive technology control, provided that the user specific EMG calibration is done. With the EEG, even though the results were promising, due to insufficient detection of the signal, the controller was not adequate to be used within a neurorehabilitation environment. The survey indicated that the usability of the system is not a barrier for moving the system into clinical trials.Implication on rehabilitationFor the rehabilitation of patients suffering from neurological disabilities (particularly those suffering from varying degrees of paralysis), it is necessary to develop technology that bypasses the limitations of their condition. For example, if a patient is unable to walk due to the unresponsiveness in their motor neurons, technology can be developed that used an alternate input to move an exoskeleton, which enables the patient to walk again with the assistance of the exoskeleton.This research focuses on neuro-rehabilitation within the framework of the NHS at the Kent and Canterbury Hospital in UK. The hospital currently does not have any system in place for self-driven rehabilitation and instead relies on traditional rehabilitation methods through assistance from physicians and exercise regimens to maintain muscle movement.This paper summarises the development of a portable and cost-efficient BCI controlled assistive technology using a non-invasive BCI headset "OpenBCI" and an open source robotic arm, U-Arm, to accomplish tasks related to rehabilitation, such as access to resources, adaptability or home use. The resulting system used a combination of EEG and EMG sensor readings to control the arm, which could perform a number of different tasks such as picking/placing objects or assist users in eating.

Knowledge, attitudes, and fear of COVID-19 during the Rapid Rise Period in Bangladesh.

The study aims to determine the level of Knowledge, Attitude, and Practice (KAP) related to COVID-19 preventive health habits and perception of fear towards COVID-19 in subjects living in Bangladesh. DESIGN: Prospective, cross-sectional survey of (n = 2157) male and female subjects, 13-88 years of age, living in Bangladesh. METHODS: Ethical approval and trial registration were obtained before the commencement of the study. Subjects who volunteered to participate and signed the informed consent were enrolled in the study and completed the structured questionnaire on KAP and Fear of COVID-19 scale (FCV-19S). RESULTS: Twenty-eight percent (28.69%) of subjects reported one or more COVID-19 symptoms, and 21.4% of subjects reported one or more co-morbidities. Knowledge scores were slightly higher in males (8.75± 1.58) than females (8.66± 1.70). Knowledge was significantly correlated with age (p < .005), an education level (p < .001), attitude (p < .001), and urban location (p < .001). Knowledge scores showed an inverse correlation with fear scores (p < .001). Eighty-three percent (83.7%) of subjects with COVID-19 symptoms reported wearing a mask in public, and 75.4% of subjects reported staying away from crowded places. Subjects with one or more symptoms reported higher fear compared to subjects without (18.73± 4.6; 18.45± 5.1). CONCLUSION: Bangladeshis reported a high prevalence of self-isolation, positive preventive health behaviors related to COVID-19, and moderate to high fear levels. Higher knowledge and Practice were found in males, higher education levels, older age, and urban location. Fear of COVID-19 was more prevalent in female and elderly subjects. A positive attitude was reported for the majority of subjects, reflecting the belief that COVID-19 was controllable and containable.

Neuro-rehabilitation service during COVID-19 pandemic: Best practices from UK.

This paper provides the context of COVID-19 outbreak with special reference to hospital-based neurorehabilitation services in the UK and transferrable lessons for similar services globally. While the COVID-19 pandemic has created numerous challenges at all levels and forced us to confront our own vulnerabilities as individuals, teams, services, communities and on the global stage, it has also simultaneously offered us opportunities for transformation. Converting catastrophe into opportunity requires creativity, diligence, innovation, strategy and vision. This reflection serves to identify the challenges we encountered, the solutions we applied and the opportunities that we have taken. In the wake of an information avalanche, service and clinical practice challenge, service capacity challenge and above all, a unique and timely reminder of our own humanity and the inter-connectedness and fragility of human societies, we have endeavoured to identify and describe some crucial leadership facets, which are supporting our journey through this global health crisis.

Capacity & capability building for applied dementia research in low- & middle-income countries: Two exemplars from South Asia.

BACKGROUND & OBJECTIVES: Cognitive and other neurodegenerative conditions related to ageing have become public health priorities in low- and middle-income countries. However, contextually based, applied research to support the development of awareness, diagnosis and care pathways for people with dementia in South Asia is still largely undeveloped. This study was aimed to use applied research studies for dementia in South Asia as exemplars of how individual-level capacity and capability building for dementia research can be achieved. METHODS: Using Theory of Change as a framework, we embedded capacity and capability building into the studies through six domains: people (human resources), research integrity and governance, study delivery skills, international collaborative working, patient and public involvement (PPI) (awareness raising, stigma and health literacy) and development of 'pathways'. For each aspect, development goals were defined and how they would be achieved. RESULTS: New principal investigators, research assistants (including outcome raters), study coordinators and intervention practitioners were trained across eight study sites in India, Pakistan, and Bangladesh, for dementia research. Training was delivered at study start, and through booster sessions, using workshops, face-to-face sessions, online training and video-link sessions. International collaborations were fostered, leading to a proposal for international funding. Each study site co-created PPI events to raise awareness and to inform the research. The recruitment pathways and study logistics fostered the development dementia diagnosis and care pathways. INTERPRETATION & CONCLUSIONS: Embedding capacity and capability building in applied dementia research in South Asia fosters the sustainability of dementia research, which is essential in developing diagnostic and care pathways.

Neuropsychiatric Outcomes in UK Military Veterans With Mild Traumatic Brain Injury and Vestibular Dysfunction.

OBJECTIVE: To estimate the frequency of vestibular dysfunction following blunt, blast, and combined blunt and blast mild traumatic brain injury (mTBI) and thereon assess the long-term impact of vestibular dysfunction on neurobehavioral function and disability independently of comorbid psychiatric symptoms. SETTING: Combat Stress residential and Veterans' Outreach drop-in centers for psychological support. PARTICIPANTS: One hundred sixty-two help-seeking UK military veterans. MAIN MEASURES: Self-reported frequency and severity of mTBI (using the Ohio State TBI Identification Method), Vertigo Symptom Scale, PTSD Checklist for DSM-5, Kessler Psychological Distress Scale (K10), Neurobehavioral Symptom Inventory, Headache Impact Test (HIT6), Memory Complaints Inventory, World Health Organization Disability Assessment Schedule II short version (WHODAS 2.0). RESULTS: Seventy-two percent of the sample reported 1 or more mTBIs over their lifetime. Chi-square analyses indicated that vestibular disturbance, which affected 69% of participants, was equally prevalent following blunt (59%) or blast (47%) injury and most prevalent following blunt and blast combined (83%). Mediation analysis indicated that when posttraumatic stress disorder, depression, and anxiety were taken into account, vestibular dysfunction in participants with mTBI was directly and independently associated with increased postconcussive symptoms and functional disability. CONCLUSION: Vestibular dysfunction is common after combined blunt and blast mTBI and singularly predictive of poor long-term mental health. From a treatment perspective, vestibular rehabilitation may provide relief from postconcussive symptoms other than dizziness and imbalance.

Caloric vestibular stimulation for the management of motor and non-motor symptoms in parkinson's disease: Intention-to-treat data.

This report provides data related to the safety and effectiveness of repeated time-varying caloric vestibular stimulation (CVS) as a treatment for motor and non-motor features of Parkinson's disease (PD). Forty-six subjects receiving stable anti-Parkinsonian therapy were randomized to active (n = 23) or placebo (n = 23) treatment arms. Subjects self-administered CVS twice-daily over a period of 8 weeks at home via a portable, pre-programmed, solid-state ThermoNeuroModulation (TNM™) device delivering continually-varying thermal waveforms through aluminium ear-probes mounted on a wearable headset. Change scores from baseline to end of treatment and to a 1-month follow-up were determined using standardized clinical measures. The data presented here report sample demographics, detailed safety data and the statistical outcomes from the intention-to-treat and modified intention-to-treat analyses. These data supplement findings of the main per protocol analysis reported in the allied article entitled, 'Caloric Vestibular Stimulation for the Management of Motor and Non-Motor Symptoms in Parkinson's Disease' Wilkinson et al.

Caloric vestibular stimulation for the management of motor and non-motor symptoms in Parkinson's disease.

INTRODUCTION: A recent case study showed that repeated sessions of caloric vestibular stimulation (CVS) relieved motor and non-motor symptoms associated with Parkinson's disease (PD). Here we sought to confirm these results in a prospective, double-blind, randomized, placebo treatment-controlled study. METHODS: 33 PD subjects receiving stable anti-Parkinsonian therapy completed an active (n = 16) or placebo (n = 17) treatment period. Subjects self-administered CVS at home twice-daily via a portable, pre-programmed, solid-state ThermoNeuroModulation (TNM™) device, which delivered continually-varying thermal waveforms through aluminum ear-probes mounted on a wearable headset. Subjects were followed over a 4-week baseline period, 8 weeks of treatment and then at 5- and 24-weeks post-treatment. At each study visit, standardized clinical assessments were conducted during ON-medication states to evaluate changes in motor and non-motor symptoms, activities of daily living, and quality of life ratings. RESULTS: Change scores between baseline and the end of treatment showed that active-arm subjects demonstrated clinically-relevant reductions in motor and non-motor symptoms that were significantly greater than placebo-arm subjects. Active treatment was also associated with improved scores on activities of daily living assessments. Therapeutic gains were still evident 5 weeks after the end of active treatment but had started to recede at 24 weeks follow-up. No serious adverse events were associated with device use, and there was high participant satisfaction and tolerability of treatment. CONCLUSION: The results provide evidence that repeated CVS can provide safe and enduring adjuvant relief for motor and non-motor symptoms associated with PD.

Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the safety and efficacy of a novel solid-state, caloric vestibular stimulation (CVS) device to provide adjuvant therapy for the prevention of episodic migraine in adult migraineurs. BACKGROUND: Migraine causes significant disability in ∼12% of the world population. No current migraine preventive treatment provides full clinical relief, and many exhibit high rates of discontinuation due to adverse events. Thus, new therapeutic options are needed. CVS may be an effective and safe adjuvant-therapy for the prevention of episodic migraine. METHODS: In a multicenter, parallel-arm, block-randomized, placebo-controlled clinical trial (clinicaltrials.gov: NCT01899040), subjects completed a 3-month treatment with the TNM™ device for CVS (refer to Fig. 2 for patient enrollment and allocation). The primary endpoint was the change in monthly migraine days from baseline to the third treatment month. Secondary endpoints were 50% responder rates, change in prescription analgesic usage and difference in total subjective headache-related pain scores. Device safety assessments included evaluation of any impact on mood, cognition, or balance. RESULTS: Per-protocol, active-arm subjects showed immediate and continued steady declines in migraine frequency over the treatment period. After 3 months of treatment, active-arm subjects exhibited significantly fewer migraine days (-3.9 ± 0.6 from a baseline burden of 7.7 ± 0.5 migraine days). These improvements were significantly greater than those observed in control subjects (-1.1 ± 0.6 from a baseline burden = 6.9 ± 0.7 migraine days) and represented a therapeutic gain of -2.8 migraine days, CI = -0.9 to -4.7, P = .012. Active arm subjects also reported greater reductions in acute medication usage and monthly pain scores compared to controls. No adverse effects on mood, cognition, or balance were reported. Subjects completed the trial with an average rate of 90% treatment adherence. No serious or unexpected adverse events were recorded. The rate of expected adverse events was similar across the active and the placebo groups, and evaluation confirmed that subject blinding remained intact. CONCLUSION: The TNM™ device for CVS appears to provide a clinically efficacious and highly tolerable adjuvant therapy for the prevention of episodic migraine.

Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid.

BACKGROUND: The RAPPER II study investigates the feasibility, safety and acceptability of using the REX self-stabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users. Feasibility is assessed by the completion of transfer into the REX device, competency in achieving autonomous control and completion of upper body exercise in an upright position in the REX device. Safety is measured by the occurrence of serious adverse events. Device acceptability is assessed with a user questionnaire. METHODS: RAPPER II is a prospective, multi-centre, open label, non-randomised, non-comparative cohort study in people with SCI recruited from neurological rehabilitation centres in the United Kingdom, Australia and New Zealand. This is the planned interim report of the first 20 participants. Each completed a transfer into the REX, were trained to achieve machine control and completed Timed Up and Go (TUG) tests as well as upper body exercises in standing in a single first time session. The time to achieve each task as well as the amount of assistance required was recorded. After finishing the trial tasks a User Experience questionnaire, exploring device acceptability, was completed. RESULTS: All participants could transfer into the REX. The mean transfer time was 439 s. Nineteen completed the exercise regime. Eighteen could achieve autonomous control of the REX, 17 of whom needed either no assistance or the help of just one therapist. Eighteen participants completed at least one TUG test in a mean time of 313 s, 15 with the assistance of just one therapist. The questionnaire demonstrated high levels of acceptability amongst users. There were no Serious Adverse Events. CONCLUSIONS: This first interim analysis of RAPPER II shows that it is feasible and safe for people with SCI to use the REX powered assisted walking device to ambulate and exercise in. Participants with tetraplegia and paraplegia could walk and perform a functional exercise program when standing needing only modest levels of assistance in most cases. User acceptability was high. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02417532 . Registered 11 April 2015.