The Synergistic Effects of AIH and FES in Persons With MS

Exploring the Synergistic Effects of AIH and FES in Persons With MS

Running, not recruitingNot a drug-phase studyRelapsing and progressiveNCT06413602

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Acute Intermittent Hypoxia
  • Neuromuscular Electrical Stimulation

What it measured

Main measures

  • Motor Evoked Potentials (MEPs) in Ankle Dorsiflexors

    Immediately prior to and within 60 minutes after the intervention.

    Myelin repairNerve conduction tests

Other measures (3)

  • Ankle Dorsiflexion Torque

    Immediately prior to and within 60 minutes after the intervention.

    Physical function

  • Ankle Dorsiflexion EMG

    Immediately prior to and within 60 minutes after the intervention.

  • Symbol Digit Modalities Test

    Immediately prior to and within 60 minutes after the intervention.

    Thinking and memory

Who could take part

Relapsing and progressive · 18 to 75

Show the full criteria

Inclusion criteria

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 injury * Unexplained frequent or severe headaches * Pregnancy in females * Implanted devices (e.g., pacemakers, medical pumps, brain stimulators) * Unable to participate in TMS

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Nov 2024

    2. Main results due

      Aug 2026

    3. Finished

      Aug 2027

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