Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-01 @ 5:55 PM
Study NCT ID:
NCT06276634
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2023-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intermittent Hypoxia in Persons With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007317', 'term': 'Insemination, Artificial, Homologous'}], 'ancestors': [{'id': 'D007315', 'term': 'Insemination, Artificial'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007314', 'term': 'Insemination'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled, cross-over, repeated measures study design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Timed 25 Feet Walk test', 'timeFrame': 'Before and following each 5-day intervention block', 'description': 'A part of the MS functional composite. Participants will be directed to walk across a 25-foot course as quickly and safely as possible.'}, {'measure': 'Six-Minute Walk test', 'timeFrame': 'Before and following each 5-day intervention block', 'description': 'The Six-minute walk test is an assessment to measure the distance able to be traversed by a participant in 6-minutes'}, {'measure': 'Stride length', 'timeFrame': 'Before and following each 5-day intervention block', 'description': 'This assessment involves walking at normal walking pace over flat ground. The GAITRite®, a pressure sensitive walkway, will be used to measure and analyze spatiotemporal gait parameters, particularly stride length in meters'}, {'measure': '12-Item Multiple Sclerosis walk scale (MSWS-12)', 'timeFrame': 'Before and following each 5-day intervention block', 'description': "This is a self-reported measure of the impact of MS on an individual's walking ability Minimum score: 12 Maximum score: 60 A lower score indicates better walking ability, less affected by the multiple sclerosis"}, {'measure': 'Resting-State fMRI', 'timeFrame': 'Before and following each 5-day intervention block', 'description': 'Participants will undergo an 2D T2\\* weighted multi-band multi-echo gradient echo-planar imaging sequence at rest'}], 'primaryOutcomes': [{'measure': 'Ankle Plantarflexion Strength', 'timeFrame': 'Before and following each 5-day intervention block', 'description': 'Participants will be seated in an adjustable chair with tested foot secured to a foot plate with the ankle in line with a rotational load cell. Participants will be asked to produce maximal ankle plantarflexion contractions, Electromyographic signals of the gastrocnemius, tibialis anterior, and soleus will be recorded simultaneously'}], 'secondaryOutcomes': [{'measure': 'Task fMRI', 'timeFrame': 'Before and following each 5-day intervention block', 'description': 'This outcome observes neural activations during voluntary muscle activations'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'AIH', 'Hypoxia'], 'conditions': ['Multiple Sclerosis', 'Multiple Sclerosis-Relapsing-Remitting', 'Multiple Sclerosis, Secondary Progressive']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Recent research has shown that AIH, characterized by brief episodes of reduced oxygen levels in the inspired air, has the potential to induce neural adaptations. These adaptations are suspected to influence several aspects of neuroplasticity, including the modulation of neurotransmitters and neurotrophic factors. Persons with MS typically exhibit greater cortical activation to achieve a given motor task compared to healthy controls, suggesting compensatory activations in motor cortices and the recruitment of additional non-motor regions for successful motor control. Therefore, interventions that promote adaptive neuroplasticity in motor control systems may induce a reduction in fMRI activation during motor tasks as well as an increase in functional connectivity between somatomotor cortices. This study will explore potential mechanisms of this intervention in MS using motor task performance and advanced neuroimaging techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnoses of relapsing form of MS (including relapsing-remitting MS and secondary-progressive MS)\n* Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5\n* Motor Functional System Scale (FSS) between 2-4\n* Relapse free for at least 1 year\n* Age ≥ 18 years and ≤ 75 years\n* Safe to be scanned based on MRI questionnaire\n* Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening\n\nExclusion Criteria:\n\n* Active contrast-enhancing MS lesions, or diffusion positive lesions suggestive of acute cerebrovascular disease on baseline MRI scan\n* Uncontrolled hypertension (Systolic between 85 and 140, diastolic between 90 and 55)\n* History of epilepsy\n* Chronic obstructive pulmonary disease\n* Uncontrolled Sleep apnea\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06276634', 'briefTitle': 'Intermittent Hypoxia in Persons With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Intermittent Hypoxia Initiated Motor Plasticity in Individuals With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'STU00219535'}, 'secondaryIdInfos': [{'id': 'R21HD108587', 'link': 'https://reporter.nih.gov/quickSearch/R21HD108587', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AIH First', 'description': 'Participants in the AIH First arm will undergo 5 days of Acute Intermittent Hypoxia Interventions. Following the 5 Days of AIH, after a 2-week washout period, this group will then undergo 5 days of Sham AIH Interventions. The procedures are identical to AIH but with 21% oxygen for both breath cycles', 'interventionNames': ['Other: Acute Intermittent Hypoxia', 'Other: Sham-Acute Intermittent Hypoxia']}, {'type': 'EXPERIMENTAL', 'label': 'Sham First', 'description': 'Participants in the Sham First arm will undergo 5 days of Sham-Acute Intermittent Hypoxia Interventions. Following the 5 Days of Sham-AIH, after a 2-week washout period, this group will then undergo 5 days of AIH Interventions. The procedures are identical to Sham-AIH but with 9-10% oxygen for the first breath cycle', 'interventionNames': ['Other: Acute Intermittent Hypoxia', 'Other: Sham-Acute Intermittent Hypoxia']}], 'interventions': [{'name': 'Acute Intermittent Hypoxia', 'type': 'OTHER', 'otherNames': ['AIH'], 'description': '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.', 'armGroupLabels': ['AIH First', 'Sham First']}, {'name': 'Sham-Acute Intermittent Hypoxia', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['AIH First', 'Sham First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Barry, MS, CCRC', 'role': 'CONTACT', 'email': 'abarry@sralab.org', 'phone': '3122381435'}, {'name': 'Milap Sandhu, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Molly Bright, D.Phil.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shirley Ryan AbilityLab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Alexander Barry, MS, CCRC', 'role': 'CONTACT', 'email': 'abarry@sralab.org', 'phone': '3122381435'}], 'overallOfficials': [{'name': 'Milap Sandhu, Pt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shirley Ryan AbilityLab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not currently have a plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Northwestern University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Milap Sandhu', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}