The Synergistic Effects of AIH and FES in Persons With MS (NCT06413602) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Synergistic Effects of AIH and FES in Persons With MS
United States40 participantsStarted 2024-11-01
Plain-language summary
The purpose of this study is to examine how neuromuscular electrical stimulation (NMES), may synergistically enhance corticospinal excitability in people with relapsing form multiple sclerosis (MS). This is an important intermediate step to evaluate the potential of AIH + NMES as a plasticity-priming strategy for more efficacious interventions for persons with MS. This study will measure ankle torque generation and amplitude of motor evoked potentials (MEPs) using a repeated measures study design in order to better understand the effects of AIH combined with NMES, as compared to only receiving NMES, and only receiving AIH.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for persons with MS:
* Diagnosis of relapsing form of MS
* Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5
* Relapse free for at least 1 year
* Age ≥18 years and ≤75 years
* No change in Dalfampridine dose at least 2 months prior to enrollment
Exclusion Criteria for persons with MS:
* Uncontrolled hypertension or hypotension (outside 140/90 and 90/60 mmHg)
* History of epilepsy or seizures
Inclusion Criteria for uninjured controls:
* Age ≥18 years and ≤75 years
* Safe to participate in TMS (TMS questionnaire)
Exclusion Criteria for uninjured controls:
* Uncontrolled hypertension or hypotension (outside 140/90 and 90/60 mmHg)
* History of epilepsy or seizures
Exclusion criteria to TMS participation for persons with MS and uninjured controls:
* Uncontrolled medical problems affecting the lungs (pulmonary diseases including chronic obstructive pulmonary disease), the heart (cardiovascular diseases) or the musculoskeletal system (orthopedic diseases)
* Premorbid, ongoing major depression or psychosis, altered cognitive status
* History of stroke
* Metal in head (e.g., surgical clips, shrapnel)
* History of seizures or epilepsy diagnosis
* Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
* Surgery to the head
* Any non-MS related neurological diseases
* Illnesses that may have caused brain…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Motor Evoked Potentials (MEPs) in Ankle Dorsiflexors
Timeframe: Immediately prior to and within 60 minutes after the intervention.