Neuromodulation in MS Using Translingual Stimulation (NeuroMSTraLS)

• ClinicalTrials.gov Identifier: NCT05275049
• Recruitment Status: Unknown
• First Posted: March 11, 2022
• Last Update Posted: March 11, 2022
• Sponsor: University of Saskatchewan
• Collaborator: Memorial University of Newfoundland
• Information provided by (Responsible Party): Sarah Donkers, University of Saskatchewan

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Combination Product: PT plus translingual stimulation device; Combination Product: PT plus translingual stimulation control device	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Translingual Stimulation Combined With Physiotherapy to Improve Walking and Balance in Multiple Sclerosis: an RCT
• Actual Study Start Date: July 5, 2021
• Estimated Primary Completion Date: July 5, 2022
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Timed 25 foot walk test (T25FWT) [ Time Frame: 27 weeks ]
   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
2. Dynamic Gait Index (DGI) [ Time Frame: 27 weeks ]
   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.

Secondary Outcome Measures :

1. Multiple Sclerosis Impact Scale (MSIS-29) [ Time Frame: 27 weeks ]
   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.
2. Fatigue Scale for Motor and Cognitive Functions [ Time Frame: 27 weeks ]
   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.
3. Short From 36 Health Survey Questionnaire (SF-36) [ Time Frame: 27 weeks ]
   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
4. Multiple sclerosis walking scale - 12 item (MSWS-12) [ Time Frame: 27 weeks ]

   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.

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

Canada, Newfoundland and Labrador

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada, A1A 1E5

Canada, Saskatchewan

University of Saskatchewan

Saskatoon, Saskatchewan, Canada, S7N 2Z4

Sponsors and Collaborators

University of Saskatchewan

Memorial University of Newfoundland

Investigators

• Principal Investigator: Sarah Donkers; University of Saskatchewan
• Principal Investigator: Michelle Ploughman; Memorial University of Newfoundland

More Information

• Responsible Party: Sarah Donkers, Principal Investigator, Assistant Professor, University of Saskatchewan
• ClinicalTrials.gov Identifier: NCT05275049
• Other Study ID Numbers: Bio 2578
• First Posted: March 11, 2022
• Last Update Posted: March 11, 2022
• Last Verified: March 2022

• 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

Keywords provided by Sarah Donkers, University of Saskatchewan:

physiotherapy; walking and balance; neurorehabilitation; non-invasive cranial nerve neuromodulation

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases