[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643835":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":11,"responsibleParty":43,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":11},{"fullName":5,"class":6},"Shirley Ryan AbilityLab","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"AIH + MINT","ACTIVE_COMPARATOR",null,[13,14],"Other: Acute Intermittent Hypoxia (AIH)","Other: Myoelectric Interface Neurorehabilitation Training (MINT)",{"label":16,"type":17,"description":11,"interventionNames":18},"SHAM AIH + MINT","SHAM_COMPARATOR",[19,14],"Other: Sham Acute Intermittent Hypoxia (AIH)",[21,25,29],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"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.",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"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.",[16],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"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.\n\nsEMG 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.\n\nEach 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",[9,16],[34],{"name":35,"affiliation":5,"role":36},"Milap Sandhu, PT, PhD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Rachel A Kalvakota, OTD, OTR\u002FL","CONTACT","1-312-238-3947","rkalvakota@sralab.org",{"type":36,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Milap Sandhu","Principal Investigator","100643835","acute-intermittent-hypoxia-combined-with-gait-training-in-multiple-sclerosis-100643835",false,"NCT07631923","Acute Intermittent Hypoxia Combined With Gait Training in Multiple Sclerosis","Acute Intermittent Hypoxia (AIH) Primed Myoelectric Interface Neurorehabilitation Training (MINT) for Gait Recovery in Multiple Sclerosis","MINT","Inclusion Criteria:\n\n* Diagnosis of clinically definite multiple sclerosis\n* Patient-Determined Disease Steps (PDDS) score between 3 and 6\n* Relapse-free for at least 6 months prior to enrollment\n* Age ≥ 18 years and ≤ 75 years\n* Resting oxygen saturation (SpO₂) ≥ 95% on room air\n* Systolic blood pressure between 85-140 mmHg and diastolic blood pressure between 55-90 mmHg\n* Modified Ashworth Scale (MAS) score ≤ 3 at the ankle and knee\n* Mini-Mental State Examination (MMSE) score ≥ 24\n* Ability to walk at least 10 meters with or without an assistive device\n* Ability to perform active ankle dorsiflexion and plantarflexion\n\nExclusion Criteria:\n\n* Uncontrolled hypertension or hypotension outside the required ranges\n* History of epilepsy or seizures\n* Uncontrolled pulmonary, cardiovascular, or orthopedic disease\n* Premorbid or ongoing major psychiatric illness (e.g., major depression, psychosis)\n* Other neurological disease (e.g., stroke, traumatic brain injury, peripheral neuropathy)\n* Illnesses with potential to cause brain injury\n* Frequent or severe unexplained headaches\n* Pregnancy\n* Implanted medical devices (e.g., pacemakers, intrathecal pumps, brain stimulators)","ALL","18 Years","75 Years",{"count":58,"type":59},35,"ESTIMATED","INTERVENTIONAL",[62],"NA","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\u002For overground gait training, with outcome measures collected before and after the intervention across multiple sessions.",[65,66,67,68],"Multiple Sclerosis","Multiple Sclerosis (MS) - Relapsing-remitting","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive",[70,71,72,73,74,75,76,77,78,79],"hypoxia","neuroplasticity","rehabilitation","gait","recovery","walking","walk","lower extremities","strength","AIH","NOT_YET_RECRUITING","2026-06-02",{"date":83,"type":84},"2026-06-08","ACTUAL",{"date":86,"type":59},"2026-06-15",{"date":88,"type":59},"2028-06-01",{"name":5,"class":6}]