Neuromodulation in MS Using Translingual Stimulation

NCT ID: NCT05275049

Last Updated: 2022-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-05

Study Completion Date

2022-12-01

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).

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PT plus translingual stimulation device

Intervention Type 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 + 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.

Group Type ACTIVE_COMPARATOR

PT plus translingual stimulation control device

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial University of Newfoundland

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Sarah Donkers

Principal Investigator, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Donkers

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Michelle Ploughman

Role: PRINCIPAL_INVESTIGATOR

Memorial University of Newfoundland

Locations

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Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Site Status

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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Bio 2578

Identifier Type: -

Identifier Source: org_study_id

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