Neuromodulation in MS Using Translingual Stimulation (NeuroMSTraLS)

University of Saskatchewan

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Combination Product: PT plus translingual stimulation control device; Combination Product: PT plus translingual stimulation device

Study type: Interventional

Funder types: Other

Identifiers

NCT05275049

Bio 2578

Details and patient eligibility

About

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).

Full 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).

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups

PT+ Device

Experimental group

Description:

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.

Treatment:

Combination Product: PT plus translingual stimulation device

PT + Control Device

Active Comparator group

Description:

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.

Treatment:

Combination Product: PT plus translingual stimulation control device