Neuromodulation in MS Using Translingual Stimulation

Study Overview
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Brief Summary
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The overarching aim of this study is to examine if there is additional benefit to adding trans-lingual electrical stimulation to physiotherapy aimed at improving walking and balance in people with multiple sclerosis (MS).

Detailed Description
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This is a two arm, participant-blinded, interventionist blinded, and research assessor-blinded RCT Participants with walking problems due to MS (Patient Determined Disease Steps PDDS 3-6) will be randomized 1:1 after baseline assessment stratified into 2 arms (lower walking disabilities PDDS 3+4, and higher walking disabilities PDDS 5+6) Following a 14 week balance and walking training intervention, participants will be instructed to continue to exercise independently according to the evidence-based Physical Activity Guidelines in MS for a subsequent 12 weeks. They will be reassessed at the end of that time (FOLLOW-UP).

Official Title
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Translingual Stimulation Combined With Physiotherapy to Improve Walking and Balance in Multiple Sclerosis: an RCT

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Combination Product: PT plus translingual stimulation device
* Combination Product: PT plus translingual stimulation control device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis of multiple sclerosis gait deficit due to MS but still able to walk (EDSS less than 6.5, PDDS 3-6) older than 18 and less than 70 years of age agree to the study time commitment. Exclusion Criteria: currently attending physical rehabilitation for walking and/or balance training, currently already functional community ambulators (gait speed>120cm/s) contra-indications to the use of translingual electrical stimulation (active or suspected malignant tumor; recent bleeding or open wounds in mouth; women who are pregnant, or sensitivity to nickel, gold or copper)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PT+ Device<br>PT plus translingual stimulation device PoNS device will be used to deliver trans-lingual electrical stimulation. The stimulation will be delivered while the participants engages in evidence-based physiotherapy for walking and balance. | Combination Product: PT plus translingual stimulation device<br>* PoNS device will be used to deliver trans-lingual electrical stimulation. The stimulation will be delivered while the participants engages in evidence-based physiotherapy for walking and balance.<br>|
| Active Comparator: PT + Control Device<br>PT plus translingual stimulation control device Control device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance. | Combination Product: PT plus translingual stimulation control device<br>* Control device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 25 foot walk test (T25FWT) | The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. Time to complete the T25FWT, and walking seed will be calculated. A lower time and faster walking speed indicates better walking performance | 27 weeks | 
| Dynamic Gait Index (DGI) | This scale has 8 conditions that an individual walks in (e.g. normal, head turns, change in speed, pivot, stairs). Performance for each condition is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best score on the DGI is 24, and a higher score means less walking impairment. | 27 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sclerosis Impact Scale (MSIS-29) | This is a 29 item self-reported questionnaire - 20 items deal with physical state and 9 with psychological. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 not at all to 5extremely. Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where a larger number (e.g. closer to 100) indicates greater impact of disease on daily function. | 27 weeks | 
| Fatigue Scale for Motor and Cognitive Functions | This is a 20-item self-reported questionnaire, a Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made as 10 questions relate to motor fatigue and 10 to cognitive fatigue. A higher score means the individuals is more affected by fatigue. | 27 weeks | 
| Short From 36 Health Survey Questionnaire (SF-36) | This is a self-reported questionnaire used to rate health related quality of life. Eight health concepts are covered in 36 questions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The 36 items are rated using a number of different scales and an intricate formula is used to calculate a final score. A high score defines a more favorable health state | 27 weeks | 
| Multiple sclerosis walking scale - 12 item (MSWS-12) | This is a 12 item self-reported questionnaire where participants rate each item from 1-5, giving a total out of 60, and then transforming this to a scale with a range from 0 to 100%. Higher scores indicate a greater impact on walking than lower scores. | 27 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive cranial nerve neuromodulation, physiotherapy, walking and balance, neurorehabilitation