Neuromodulation in MS Using Translingual Stimulation

NCT05275049 | Unknown DMC FDA Device

• 1 other identifier: Bio 2578
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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).

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Multiple Sclerosis Impact Scale (MSIS-29)

  27 weeks

• Fatigue Scale for Motor and Cognitive Functions

  27 weeks

• Short From 36 Health Survey Questionnaire (SF-36)

  27 weeks

• Multiple sclerosis walking scale - 12 item (MSWS-12)

  27 weeks

Study Arms (2)

PT+ Device

EXPERIMENTAL

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

PT + Control Device

ACTIVE COMPARATOR

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

Interventions

PT plus translingual stimulation device COMBINATION_PRODUCT

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.

PT+ Device

PT plus translingual stimulation control device COMBINATION_PRODUCT

Control device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance.

PT + Control Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Saskatchewan: lead
• Memorial University of Newfoundland: collaborator

Study Sites (2)

Memorial University of Newfoundland

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

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 2Z4, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sarah Donkers

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

• Michelle Ploughman

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: March 11, 2022
• Study Start: July 5, 2021
• Primary Completion: July 5, 2022
• Study Completion: December 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

CA (2)