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The Synergistic Effects of AIH and FES in Persons With MS
The Synergistic Effects of AIH and FES in Persons With MS

NCT06413602

Active Not RecruitingNA

Sponsor: Shirley Ryan AbilityLab

Conditions: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive

Interventions: Acute Intermittent Hypoxia, Neuromuscular Electrical Stimulation

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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
Locations (1)
  • Chicago, Illinois, United States