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NCT07631923
Acute Intermittent Hypoxia Combined With Gait Training in Multiple Sclerosis
Conditions: Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Primary Progressive, Multiple Sclerosis (MS) Secondary Progressive
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: Shirley Ryan AbilityLab
Summary
This interventional, randomized, sham-controlled study will examine whether Acute Intermittent Hypoxia (AIH) delivered immediately before Myoelectric Interface Neurorehabilitation Training (MINT)-based locomotor training improves gait in people with Multiple Sclerosis. The primary objectives are to evaluate changes in gait speed and endurance, with secondary objectives assessing spatiotemporal gait parameters, fatigue, and safety. Participants will receive AIH or sham priming followed by standardized treadmill and/or overground gait training, with outcome measures collected before and after the intervention across multiple sessions.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of clinically definite multiple sclerosis
* Patient-Determined Disease Steps (PDDS) score between 3 and 6
* Relapse-free for at least 6 months prior to enrollment
* Age ≥ 18 years and ≤ 75 years
* Resting oxygen saturation (SpO₂) ≥ 95% on room air
* Systolic blood pressure between 85-140 mmHg and diastolic blood pressure between 55-90 mmHg
* Modified Ashworth Scale (MAS) score ≤ 3 at the ankle and knee
* Mini-Mental State Examination (MMSE) score ≥ 24
* Ability to walk at least 10 meters with or without an assistive device
* Ability to perform active ankle dorsiflexion and plantarflexion
Exclusion Criteria:
* Uncontrolled hypertension or hypotension outside the required ranges
* History of epilepsy or seizures
* Uncontrolled pulmonary, cardiovascular, or orthopedic disease
* Premorbid or ongoing major psychiatric illness (e.g., major depression, psychosis)
* Other neurological disease (e.g., stroke, traumatic brain injury, peripheral neuropathy)
* Illnesses with potential to cause brain injury
* Frequent or severe unexplained headaches
* Pregnancy
* Implanted medical devices (e.g., pacemakers, intrathecal pumps, brain stimulators)
Source: ClinicalTrials.gov (NCT07631923). StuddyBuddy aggregates publicly available trial information.