Multiple SclerosisMINTNCT07631923
Acute Intermittent Hypoxia Combined With Gait Training in Multiple Sclerosis
A study testing Acute Intermittent Hypoxia (AIH) and Myoelectric Interface Neurorehabilitation Training (MINT) in people with Multiple Sclerosis and Multiple Sclerosis (MS) - Relapsing-remitting, run by Shirley Ryan AbilityLab.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Primary Progressive
- What is being tested?
- Acute Intermittent Hypoxia (AIH) and Myoelectric Interface Neurorehabilitation Training (MINT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Frequent or severe unexplained headaches
- Pregnancy
- Implanted medical devices (e.g., pacemakers, intrathecal pumps, brain stimulators)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acute Intermittent Hypoxia (AIH) Primed Myoelectric Interface Neurorehabilitation Training (MINT) for Gait Recovery in Multiple Sclerosis
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.
Read the detailed description
The study tests whether a brief breathing treatment, acute intermittent hypoxia (AIH), can make a computer-based muscle training program (MINT) more effective for people with MS who have difficulty walking. AIH involves breathing short alternating periods of low-oxygen air (about 9% oxygen versus the roughly 21% in room air) and normal room air. The premise, drawn from work in other neurological conditions like spinal cord injury, is that AIH delivered before movement training may improve strength and walking. Whether this benefits people with MS is not yet known, which is the gap the study addresses.
MINT itself uses surface EMG sensors on the leg muscles to capture muscle activity, which then controls game-like tasks on a screen. Participants practice activating the correct muscles for walking while suppressing unwanted activity.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Primary Progressive, Multiple Sclerosis (MS) Secondary Progressive
- Being tested
- Acute Intermittent Hypoxia (AIH), Sham Acute Intermittent Hypoxia (AIH), Myoelectric Interface Neurorehabilitation Training (MINT)
- Keywords
- hypoxia, neuroplasticity, rehabilitation, gait, recovery, walking, walk, lower extremities, strength, AIH
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Intermittent Hypoxia (AIH)Other
During AIH, 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 cycle involves breathing air with lower oxygen concentration (9-10% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration. This cycle is repeated 15 times in one session. Blood oxygen and heart rate are monitored throughout.
Sham Acute Intermittent Hypoxia (AIH)Other
During Sham AIH, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention. The Sham AIH intervention involves alternating breathing cycles. One cycle involves breathing air closely resembling room air (~21% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration. This cycle is repeated 15 times in one session. Blood oxygen and heart rate are monitored throughout.
Myoelectric Interface Neurorehabilitation Training (MINT)Other
MINT is a gamified rehabilitation paradigm that uses surface electromyography (sEMG) biofeedback to retrain lower-limb muscle activation patterns. The intervention is designed to reduce abnormal coactivation of agonist-antagonist muscle pairs and facilitate more efficient torque generation during functional movements.
sEMG electrodes will be placed bilaterally over the tibialis anterior, gastrocnemius, and quadriceps muscles. EMG signals will be acquired in real time, processed, and used to control on-screen tasks within a custom Unity-based software environment. Participants will engage in interactive tasks where selective activation of target muscles allows them to move a virtual avatar, align a gauge, or achieve movement goals while minimizing antagonist activity.
Each MINT session will last approximately 60 minutes and will be delivered immediately following AIH or sham exposure. Sessions will include calibration of EMG channels, a brief familiarization period, and four to five tra
| Study group | Role | What they receive |
|---|---|---|
| AIH + MINT | Active comparator | Not described Receives: Other: Acute Intermittent Hypoxia (AIH); Other: Myoelectric Interface Neurorehabilitation Training (MINT) |
| SHAM AIH + MINT | Sham comparator | Not described Receives: Other: Sham Acute Intermittent Hypoxia (AIH); Other: Myoelectric Interface Neurorehabilitation Training (MINT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test (6MWT)
Participants walk as far as they safely can in six minutes along a marked course, and total distance (meters) is recorded.
Measured: 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).
Secondary outcomes (5)
Ten-Meter Walk Test (10MWT)
Measures gait speed over 10 meters at a self-selected comfortable pace, averaged across two trials.
Measured: Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), with retention assessed at the 1-week (Day 14 to 21) and 1-month (Day 36 to 41)
Stair Climb Test (SCT)
Assesses functional mobility and lower-limb power. Participants ascend a standardized 12-step staircase (17 cm per step, 2.04 m total) as quickly and safely as possible across three trials, with ascent time recorded and handrail use documented.
Measured: Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
Maximal Voluntary Contraction (MVC) Testing
Measures maximal strength of the trained leg on a Biodex dynamometer across ankle plantarflexion, dorsiflexion, knee flexion, and knee extension. Participants perform 3 to 5 maximal isometric contractions (10 seconds each) per movement while surface EMG quantifies agonist activation and antagonist coactivation.
Measured: Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
Fatigability Testing
Quantifies muscle fatigue as the percent decline in torque across 20 consecutive maximal isometric plantarflexion contractions (5 to 10 seconds each) on the Biodex, with surface EMG monitoring changes in activation and coactivation through the series.
Measured: Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
Ankle Proprioception Testing
Assesses joint sense on the trained leg via the Biodex while the participant is blindfolded with noise-cancelling headphones. It includes a movement detection threshold (trigger press when slow passive rotation is first felt, 5 to 6 trials) and joint position matching (reproducing a passively set target angle, 6 to 8 trials), with surface EMG confirming no compensatory activity.
Measured: aseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milap Sandhu, Shirley Ryan AbilityLab
- Investigators
- Milap Sandhu, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631923
- Sponsor's protocol ID
- STU00225287
- Acronym
- MINT
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not currently have a plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Intermittent Hypoxia (AIH) Primed Myoelectric Interface Neurorehabilitation Training (MINT) for Gait Recovery in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07631923
- Acronym / sponsor ID
- MINT / STU00225287
- Conditions
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Primary Progressive, Multiple Sclerosis (MS) Secondary Progressive
- Keywords
- hypoxia, neuroplasticity, rehabilitation, gait, recovery, walking, walk, lower extremities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study tests whether a brief breathing treatment, acute intermittent hypoxia (AIH), can make a computer-based muscle training program (MINT) more effective for people with MS who have difficulty walking. AIH involves breathing short alternating periods of low-oxygen air (about 9% oxygen versus the roughly 21% in room air) and normal room air. The premise, drawn from work in other neurological conditions like spinal cord injury, is that AIH delivered before movement training may improve strength and walking. Whether this benefits people with MS is not yet known, which is the gap the study addresses.
MINT itself uses surface EMG sensors on the leg muscles to capture muscle activity, which then controls game-like tasks on a screen. Participants practice activating the correct muscles for walking while suppressing unwanted activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIH + MINT | Active comparator | Other: Acute Intermittent Hypoxia (AIH), Other: Myoelectric Interface Neurorehabilitation Training (MINT) |
| SHAM AIH + MINT | Sham comparator | Other: Sham Acute Intermittent Hypoxia (AIH), Other: Myoelectric Interface Neurorehabilitation Training (MINT) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Intermittent Hypoxia (AIH)During AIH, 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 cycle involves breathing air with lower oxygen concentration (9-10% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration. This cycle is repeated 15 times in one session. Blood oxygen and heart rate are monitored throughout. | Other | AIH + MINT |
| Sham Acute Intermittent Hypoxia (AIH)During Sham AIH, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention. The Sham AIH intervention involves alternating breathing cycles. One cycle involves breathing air closely resembling room air (~21% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration. This cycle is repeated 15 times in one session. Blood oxygen and heart rate are monitored throughout. | Other | SHAM AIH + MINT |
| Myoelectric Interface Neurorehabilitation Training (MINT)MINT is a gamified rehabilitation paradigm that uses surface electromyography (sEMG) biofeedback to retrain lower-limb muscle activation patterns. The intervention is designed to reduce abnormal coactivation of agonist-antagonist muscle pairs and facilitate more efficient torque generation during functional movements. sEMG electrodes will be placed bilaterally over the tibialis anterior, gastrocnemius, and quadriceps muscles. EMG signals will be acquired in real time, processed, and used to control on-screen tasks within a custom Unity-based software environment. Participants will engage in interactive tasks where selective activation of target muscles allows them to move a virtual avatar, align a gauge, or achieve movement goals while minimizing antagonist activity. Each MINT session will last approximately 60 minutes and will be delivered immediately following AIH or sham exposure. Sessions will include calibration of EMG channels, a brief familiarization period, and four to five tra | Other | AIH + MINT, SHAM AIH + MINT |
Primary outcome
Six-Minute Walk Test (6MWT)
Time frame: 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).
Participants walk as far as they safely can in six minutes along a marked course, and total distance (meters) is recorded.
5 secondary outcomes
Ten-Meter Walk Test (10MWT)
Time frame: Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), with retention assessed at the 1-week (Day 14 to 21) and 1-month (Day 36 to 41)
Stair Climb Test (SCT)
Time frame: Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
Maximal Voluntary Contraction (MVC) Testing
Time frame: Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
Fatigability Testing
Time frame: Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
Ankle Proprioception Testing
Time frame: aseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No. We do not currently have a plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Milap Sandhu, PT, PhD principal investigator
Shirley Ryan AbilityLab
Questions about this trial
What is this clinical trial studying?
A study testing Acute Intermittent Hypoxia (AIH) and Myoelectric Interface Neurorehabilitation Training (MINT) in people with Multiple Sclerosis and Multiple Sclerosis (MS) - Relapsing-remitting, run by Shirley Ryan AbilityLab.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel A Kalvakota, OTD, OTR/L (1-312-238-3947, rkalvakota@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Test (6MWT) (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.