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

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 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 Details

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.

Key Dates

First listed

Jun 8, 2026

Start date

Jun 15, 2026

Status verified

Jun 2026

Primary completion

Jan 1, 2028

Completion

Jun 1, 2028

Study Design

Enrollment

35 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: AIH + MINT
• Sham Comparator: SHAM AIH + MINT

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). ]

Central Contacts

• Rachel A Kalvakota, OTD, OTR/L
  1-312-238-3947
  [email protected]

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