What this study is
This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS.
What's being tested
- Acute Intermittent Hypoxia
Intervention · OTHER
During each AIH session, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention. The AIH intervention involves alternating breathing cycles: one with lower oxygen concentration (9-10% Oxygen) than that at sea level (~21% Oxygen) lasting between 30 and 60 seconds, followed by a similar duration of normal room air (21% Oxygen). This cycle will be repeated 15 times in one session, continuous blood oxygen levels and heart rate will be monitored.
- Sham-Acute Intermittent Hypoxia
Intervention · OTHER
During each Sham-AIH session, the participant will be equipped with a non-rebreathing face mask, and provided with the Sham-AIH intervention. The Sham-AIH intervention involves alternating breathing cycles: both with oxygen concentrations of ~21% Oxygen lasting between 30 and 60 seconds, followed by another similar duration of normal room air (21% Oxygen). This cycle will be repeated 15 times in one session, continuous blood oxygen levels and heart rate will be monitored.
Study details
- Official title
- Intermittent Hypoxia Initiated Motor Plasticity in Individuals With Multiple Sclerosis
- Sponsor
- Shirley Ryan AbilityLab
- Conditions
- Multiple Sclerosis · Multiple Sclerosis-Relapsing-Remitting · Multiple Sclerosis, Secondary Progressive
- Enrolling
- 21 people
- Starts
- 2024-04-30
- Est. completion
- 2027-01
- Design
- Double-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Diagnoses of relapsing form of MS (including relapsing-remitting MS and secondary-progressive MS)
- Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5
- Motor Functional System Scale (FSS) between 2-4
- Relapse free for at least 1 year
- Age ≥ 18 years and ≤ 75 years
- Safe to be scanned based on MRI questionnaire
- Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening
You can't join if
- Active contrast-enhancing MS lesions, or diffusion positive lesions suggestive of acute cerebrovascular disease on baseline MRI scan
- Uncontrolled hypertension (Systolic between 85 and 140, diastolic between 90 and 55)
- History of epilepsy
- Chronic obstructive pulmonary disease
- Uncontrolled Sleep apnea
- Pregnancy
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openShirley Ryan AbilityLab
Chicago, Illinois, United States
- Alexander Barry, MS, CCRC · Contact3122381435abarry@sralab.org
- Milap Sandhu, PT, PhD · Principal investigator
- Molly Bright, D.Phil. · Sub-investigator
Recruiting
Study team
Sponsor
Shirley Ryan AbilityLab
Study ID STU00219535
Principal investigator
Milap Sandhu, Pt, PhD
Shirley Ryan AbilityLab
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.