Acute Intermittent Hypoxia Combined With Gait Training in Multiple Sclerosis (NCT07631923) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Acute Intermittent Hypoxia Combined With Gait Training in Multiple Sclerosis
35 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Six-Minute Walk Test (6MWT)
Timeframe: Change in distance (meters) from pre-training assessment (Day 1, before the first intervention) to Immediate Post (Day 5, after the final intervention), 1-week follow-up (Day 14-21), and 1-month follow-up (Day 36-41).