Multiple SclerosisNeuroMSTraLSNCT05275049
Neuromodulation in MS Using Translingual Stimulation
A study testing PT plus translingual stimulation device in people with Multiple Sclerosis, run by University of Saskatchewan at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- PT plus translingual stimulation device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Jul 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Canada2 sites
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 2Z4
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1A 1E5
About this study
Official title: Translingual Stimulation Combined With Physiotherapy to Improve Walking and Balance in Multiple Sclerosis: an RCT
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).
Read the 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).
- Conditions
- Multiple Sclerosis
- Being tested
- PT plus translingual stimulation device, PT plus translingual stimulation control device
- Keywords
- physiotherapy, walking and balance, neurorehabilitation, non-invasive cranial nerve neuromodulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT plus translingual stimulation deviceCombination 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 plus translingual stimulation control deviceCombination product
Control device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: PT plus translingual stimulation control device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 27 weeks
Secondary outcomes (4)
Multiple Sclerosis Impact Scale (MSIS-29)
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.
Measured: 27 weeks
Fatigue Scale for Motor and Cognitive Functions
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.
Measured: 27 weeks
Short From 36 Health Survey Questionnaire (SF-36)
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
Measured: 27 weeks
Multiple sclerosis walking scale - 12 item (MSWS-12)
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.
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start5 Jul 2021
- Primary completion5 Jul 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial University of Newfoundland
- Responsible party
- Principal investigator, Sarah Donkers, University of Saskatchewan
- Investigators
- Sarah Donkers, Principal investigator, University of SaskatchewanMichelle Ploughman, Principal investigator, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275049
- Sponsor's protocol ID
- Bio 2578
- Acronym
- NeuroMSTraLS
- Status last verified
- Mar 2022
- First submitted
- 28 Nov 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translingual Stimulation Combined With Physiotherapy to Improve Walking and Balance in Multiple Sclerosis: an RCT
- ClinicalTrials.gov ID
- NCT05275049
- Acronym / sponsor ID
- NeuroMSTraLS / Bio 2578
- Conditions
- Multiple Sclerosis
- Keywords
- physiotherapy, walking and balance, neurorehabilitation, non-invasive cranial nerve neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Memorial University of Newfoundland
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 5 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PT+ Device | Experimental | Combination Product: PT plus translingual stimulation devicePT 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. |
| PT + Control Device | Active comparator | Combination Product: PT plus translingual stimulation control devicePT plus translingual stimulation control device Control device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PT plus translingual stimulation devicePoNS 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+ Device |
| PT plus translingual stimulation control deviceControl device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance. | Combination product | PT + Control Device |
Primary outcome
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
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.
4 secondary outcomes
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: 27 weeks
Fatigue Scale for Motor and Cognitive Functions
Time frame: 27 weeks
Short From 36 Health Survey Questionnaire (SF-36)
Time frame: 27 weeks
Multiple sclerosis walking scale - 12 item (MSWS-12)
Time frame: 27 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Donkers principal investigator
University of Saskatchewan
Michelle Ploughman principal investigator
Memorial University of Newfoundland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PT plus translingual stimulation device in people with Multiple Sclerosis, run by University of Saskatchewan at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 25 foot walk test (T25FWT) (time frame: 27 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.