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 range18 Years – 75 Years

SexALL

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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…

What they're measuring

Motor Evoked Potentials (MEPs) in Ankle Dorsiflexors

Timeframe: Immediately prior to and within 60 minutes after the intervention.

Trial details

NCT IDNCT06413602

SponsorShirley Ryan AbilityLab

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08