The Synergistic Effects of AIH and FES in Persons With MS

Launched by SHIRLEY RYAN ABILITYLAB · May 9, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of two treatments—neuromuscular electrical stimulation (NMES) and a technique called active interventional hypoxia (AIH)—on individuals with relapsing forms of multiple sclerosis (MS). The goal is to see if using both treatments together can improve muscle function and brain activity better than using either treatment alone. Participants will undergo tests to measure how well they can generate force in their ankle muscles and how their brains respond to stimulation.

To be eligible for the study, participants should be between 18 and 75 years old, have a diagnosis of relapsing MS, and have certain scores on disability and functional assessments. They must also be relapse-free for at least a year and be safe to have an MRI, which is a type of scan. Participants can expect to learn more about how these treatments may help improve their condition, and they’ll be closely monitored throughout the trial. It's important to note that individuals with certain health issues, such as uncontrolled blood pressure or a history of seizures, will not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of relapsing form of MS
• • Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5
• • Motor Functional Systems Score (FSS) between 2-4
• • Relapse free for at least 1 year
• • Age ≥18 years and ≤75 years
• • Safe to participate in MRI (as indicated via the SRALab MRI questionnaire)
• • No change in Dalfampridine dose at least 2 months prior to enrollment
• Exclusion Criteria:
• • Uncontrolled hypertension or hypotension (outside 140/90 and 90/60 mmHg)
• • History of epilepsy or seizures
• • 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)
• • 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)