Clinical trial NCT05275049: Neuromodulation in MS Using Translingual Stimulation
Official title: Translingual Stimulation Combined With Physiotherapy to Improve Walking and Balance in Multiple Sclerosis: an RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: physiotherapy
walking and balance
neurorehabilitation
non-invasive cranial nerve neuromodulation
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Memorial University of Newfoundland
First posted: 2022-03-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility 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)

Primary outcomes:
measure: Timed 25 foot walk test (T25FWT)
timeFrame: 27 weeks
measure: Dynamic Gait Index (DGI)
timeFrame: 27 weeks
Secondary outcomes:
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: 27 weeks
measure: Fatigue Scale for Motor and Cognitive Functions
timeFrame: 27 weeks
measure: Short From 36 Health Survey Questionnaire (SF-36)
timeFrame: 27 weeks
measure: Multiple sclerosis walking scale - 12 item (MSWS-12)
timeFrame: 27 weeks
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Memorial University of Newfoundland
state: Newfoundland and Labrador
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Sarah Donkers
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial University of Newfoundland
name: Michelle Ploughman
role: PRINCIPAL_INVESTIGATOR
References: