Translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (NeuroMSTraLS): Study protocol for a randomized controlled trial

INTRODUCTION: Physical rehabilitation restores lost function and promotes brain plasticity in people with Multiple Sclerosis (MS). Research groups worldwide are testing the therapeutic effects of combining non-invasive neuromodulation with physical therapy (PT) to further improve functional outcomes in neurological disorders but with mixed results. Whether such devices enhance function is not clear. We present the rationale and study design for a randomized controlled trial evaluating if there is additional benefit to the synergistic pairing of translingual neurostimulation (TLNS) with PT to improve walking and balance in MS. METHODS AND ANALYSIS: A parallel group [PT + TLNS or PT + Sham], quadruple-blinded, randomized controlled trial. Participants (N = 52) with gait and balance deficits due to relapsing-remitting or progressive MS, who are between 18 and 70 years of age, will be recruited through patient registries in Newfoundland & Labrador and Saskatchewan, Canada. All participants will receive 14 weeks of PT while wearing either a TLNS or sham device. Dynamic Gait Index is the primary outcome. Secondary outcomes include fast walking speed, subjective ratings of fatigue, MS impact, and quality of life. Outcomes are assessed at baseline (Pre), after 14 weeks of therapy (Post), and 26 weeks (Follow Up). We employ multiple methods to ensure treatment fidelity including activity and device use monitoring. Primary and secondary outcomes will be analyzed using linear mixed-effect models. We will control for baseline score and site to test the effects of Time (Post vs. Follow-Up), Group and the Group x Time interaction as fixed effects. A random intercept of participant will account for the repeated measures in the Time variable. Participants must complete the Post testing to be included in the analysis. ETHICS AND DISSEMINATION: The Human Research Ethics Boards in Newfoundland & Labrador (HREB#2021.085) & Saskatchewan (HREB Bio 2578) approved the protocol. Dissemination avenues include peer-reviewed journals, conferences and patient-oriented communications

Participants’ perspectives of “NeuroSask: Active and Connect”—a virtual chronic disease management program for individuals with a neurological condition

IntroductionNeurological conditions account from more than half of Canadians requiring chronic care. Both physical activity and the development of a self-management skillset are critical components supporting individuals with chronic health conditions. “NeuroSask: Active and Connected” is a virtual chronic disease management program offering twice weekly neuro-physiotherapist directed “active” exercise sessions, followed by weekly knowledge-exchange “connect” sessions with invited guest experts. NeuroSask was launched April 2020 in response to the restricted services and supports for people with neurological conditions. The program aimed to provide seated physical activity, social interaction, and access to expertise in neurological conditions and neurorehabilitation. A program evaluation of NeuroSask was conducted to gain participants’ perspectives.MethodsAll participants registered for the NeuroSask program were invited to complete optional online surveys (SurveyMonkey) circulated by email at 3 occasions post-program launch: 10 weeks, 1 year, and 2 years. Participants could complete any one or all of the surveys, at their discretion. The number of potential respondents changed dependent on the total number of participants registered for NeuroSask at the time the survey was circulated. Questions were co-designed by multi-stakeholder team members. Descriptive statistics were used for closed-ended questions and a reflexive thematic analysis was completed with coding conducted in NVivo 12 Plus for open-ended text.ResultsResponse rates (participants/registrants) were as follows: 10-week survey 260/793, one year survey 326/1224, and 2-year survey 434/1989. 90% of participants reported being in either the age categories of 40–59 years or above 60 years. 75% of both survey respondents and program registrants were female. 70% of both survey respondents and program registrants reported a diagnosis of multiple sclerosis and 30% reported other neurological conditions. Survey respondents were from all ten Canadian provinces, with 45% reporting living outside of large cities. Respondents reported preferring online vs. in person format for this type of programming. Three main themes, and eight corresponding subthemes were identified highlighting the perceived impact and key components of the NeuroSask program: Theme 1 “together in a positive and encouraging environment” (subthemes 1a: connection, 1b: empowerment); Theme 2 “access to enthusiastic qualified leaders from home” (subthemes 2a: leader characteristics, 2b: accessibility, 2c: program logistics); Theme 3 “being able to enjoy everyday life” (subthemes 3a: symptom benefits and beyond, 3b: carry-over, 3c: keep going, please do not cancel).ConclusionNeuroSask is an example of an accessible and meaningful virtual approach to providing ongoing support for some individuals with neurological conditions. It was perceived as beneficial for fostering community and connection in a positive environment with perceived benefits extending beyond symptom management to participant reported improvements in function, daily life, and disease experience

Attenuated Auditory Event-Related Potentials and Associations with Atypical Sensory Response Patterns in Children with Autism

Neurobiological underpinnings of unusual sensory features in individuals with autism are unknown. Event-related potentials (ERPs) elicited by task-irrelevant sounds were used to elucidate neural correlates of auditory processing and associations with three common sensory response patterns (hyperresponsiveness; hyporesponsiveness; sensory seeking). Twenty-eight children with autism and 39 typically developing children (4–12 year-olds) completed an auditory oddball paradigm. Results revealed marginally attenuated P1 and N2 to standard tones and attenuated P3a to novel sounds in autism versus controls. Exploratory analyses suggested that within the autism group, attenuated N2 and P3a amplitudes were associated with greater sensory seeking behaviors for specific ranges of P1 responses. Findings suggest that attenuated early sensory as well as later attention-orienting neural responses to stimuli may underlie selective sensory features via complex mechanisms

Implementation of increased physical therapy intensity for improving walking after stroke: Walk 'n Watch protocol for a multi-site stepped-wedge cluster randomized controlled trial

Clinical practice guidelines support structured, progressive protocols for improving walking after stroke. Yet, practice is slow to change, evidenced by the little amount of walking activity in stroke rehabilitation units. Our recent study (n=75) found that a structured, progressive protocol integrated with typical daily physical therapy improved walking and quality of life measures over usual care. Research therapists progressed the intensity of exercise by using heart rate and step counters worn by the participants with stroke during therapy. To have the greatest impact, our next step is to undertake an implementation trial to change practice across stroke units where we enable the entire unit to use the protocol as part of standard of care. What is the effect of introducing structured, progressive exercise (termed the Walk 'n Watch protocol) to standard of care on the primary outcome of walking in adult participants with stroke over the hospital inpatient rehabilitation period? Secondary outcomes will be evaluated and include quality of life.Methods and sample size estimates: This national, multisite clinical trial will randomize 12 sites using a stepped-wedge design where each site will be randomized to deliver Usual Care initially for 4, 8, 12 or 16-months (three sites for each duration). Then, each site will switch to the Walk 'n Watch phase for the remaining duration of a total 20-month enrolment period. Each participant will be exposed to only one of Usual Care or Walk 'n Watch. The trial will enrol a total of 195 participants with stroke to achieve a power of 80% with a Type I error rate of 5%, allowing for 20% dropout. Participants will be medically stable adults post-stroke and able to take 5 steps with a maximum physical assistance from one therapist. The Walk 'n Watch protocol focuses on completing a minimum of 30-minutes of weight-bearing, walking-related activities (at the physical therapists' discretion) that progressively increases in intensity informed by activity trackers measuring heart rate and step number.Study outcome(s): The primary outcome will be the change in walking endurance, measured by the Six-Minute Walk Test, from Baseline (T1) to 4-weeks (T2). This change will be compared across Usual Care and Walk 'n Watch phases using a linear mixed-effects model. Additional physical, cognitive, and quality of life outcomes will be measured at T1, T2, and 12-months post-stroke (T3) by a blinded assessor. The implementation stepped-wedge cluster-randomized trial enables the protocol to be tested under real-world conditions, involving all clinicians on the unit. It will result in all sites and all clinicians on the unit to gain expertise in protocol delivery. Hence, a deliberate outcome of the trial is facilitating changes in best practice to improve outcomes for participants with stroke in the trial, and for the many participants with stroke admitted after the trial ends

Targeting Physical Activity Behaviour Change in the Management of Multiple Sclerosis

Purpose: The purpose of this thesis is to investigate how physical activity behaviour can be optimized in routine care for persons living with multiple sclerosis in Saskatchewan. Physical activity is an important behavioural intervention in the management of multiple sclerosis; however, persons living with multiple sclerosis are far less active than needed to accrue health benefits. We aimed to explore the local context from the perspectives of key end-users (persons living with multiple sclerosis and health care providers), as a starting point to address this disconnect between evidence on physical activity and rates of participation. Methods: Three studies were conducted as part of this manuscript style thesis. Study 1 used Interpretive Description, a qualitative research methodology to investigate health care providers’ current practices and perspectives regarding physical activity behavioural interventions in the management of multiple sclerosis. Focus groups were conducted with 31 multi-disciplinary health care providers in Saskatchewan working with individuals living with multiple sclerosis. Study 2 also used Interpretive Description to explore the perspectives of persons living with multiple sclerosis with regards to their priorities and proposed solutions for optimizing physical activity behaviour in the management of multiple sclerosis. Focus groups were conducted with 24 individuals living with multiple sclerosis in Saskatchewan. For both Study 1 and 2 inductive thematic analysis, triangulation and member checking were applied in data analysis. Data were coded individually by three researchers, who then collaboratively developed themes. Building on key findings from Study 1 and 2, Study 3 was a systematic review conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Study 3’s objective was to identify and synthesize the existing literature that describes methods used to train health care providers to deliver behaviour change strategies for physical activity interventions in neurological populations, including multiple sclerosis. Results: This preliminary research showed that physical activity behaviour is not currently being targeted in routine management of multiple sclerosis in Saskatchewan. Persons living with multiple sclerosis want support from their health care providers regarding physical activity behaviour change. Health care providers believe physical activity is important, but they are not currently prioritizing it in practice. Physical activity as a management strategy does not exist in isolation. Findings suggest the problem is greater than just low physical activity levels – care needs to be improved. Individual and systems level change are needed. Essential components hypothesized to optimize physical activity behaviour in the management of MS found in this thesis include support, training, model of care and communication. Both health care providers and persons living with multiple sclerosis suggested the need to address individual level change through increasing the use of behaviour change strategies. Training health care providers on behaviour change strategies is one approach at the individual level to improve physical activity behaviour change in multiple sclerosis. Based on our systematic review, there is currently insufficient evidence for consensus on what should be included in and how to structure training for HCP to increase ability, confidence and use of BCS for PA with neurological populations. With a growing number of studies showing effectiveness of BCS to increase PA in neurological populations, there is a need for future work to highlight the most important strategies as well as how to best implement their use into clinical practice. Conclusion and Significance: This PhD research is a starting point to help improve health care providers and persons living with multiple sclerosis knowledge, use and ultimately change in physical activity behaviour. The findings of this thesis show that future efforts (both research and interventions) need to acknowledge that there are barriers to utilizing PA behaviour change for PwMS at several levels (individual, health care system, community and policy), and work is needed at each of these levels in order to implement change. Taking an integrated knowledge translation approach to further the next steps in research is recommended to promote concurrent and complimentary change needed. Future efforts should target the key factors of support, training, model of care and communication found in this thesis to address localized priorities, to maximize potential applicability to end-users and to effect meaningful change

Cognitive Impairment: Non-pharmacological Rehabilitation Interventions

No abstract available