Neuromodulation in MS Using Translingual Stimulation (NeuroMSTraLS)

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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Combination product: PT plus translingual stimulation device; Combination product: PT plus translingual stimulation control device

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 1E5
      • Memorial University of Newfoundland
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 2Z4
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PT+ Device; 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; 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.
Active Comparator: PT + Control Device; 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; Control device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance.

What is the study measuring?

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 5"extremely". 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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Memorial University of Newfoundland
• Investigators: Principal Investigator: Sarah Donkers, University of Saskatchewan; Principal Investigator: Michelle Ploughman, Memorial University of Newfoundland

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Anticipated): July 5, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 28, 2021
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: physiotherapy; neurorehabilitation; walking and balance; non-invasive cranial nerve neuromodulation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Bio 2578

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes