Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-02 @ 11:08 AM
Study NCT ID:
NCT03691766
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2018-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photobiomodulation Therapy in Persons With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2018-09-28', 'studyFirstSubmitQcDate': '2018-10-01', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Fatigue', 'timeFrame': 'up to 4 week photobiomodulation intervention, immediately after the intervention, and then 4 months after this extended treatment', 'description': 'Change in muscle fatigue or recovery after photobiomodulation therapy'}], 'secondaryOutcomes': [{'measure': 'Systemic Inflammation', 'timeFrame': 'up to 4 week photobiomodulation intervention, and then again at 4 months post-intervention', 'description': 'Change in pro- and anti-inflammatory cytokines.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'descriptionModule': {'briefSummary': 'This study will test whether photobiomodulation therapy improves muscle endurance and decreases inflammation in persons with relapsing-remitting multiple sclerosis. We will also investigate mechanisms for any improvements.', 'detailedDescription': 'Persons with multiple sclerosis (MS) MS commonly experience muscle weakness and fatigue which may contribute to the commonly reported symptomatic fatigue. Photobiomodulation therapy (PBMT) induced with light in the visible red to near infrared (VIS/NIR) region of the spectrum (600-1000 nm) can stimulate cytochrome c oxidase and improve mitochondrial function. PBMT is an emerging therapeutic modality for soft tissue injury, chronic inflammation, neurodegeneration , and retinal diseases. PBMT has also been used to enhance muscle endurance, strength and recovery in healthy adults. We propose that in persons with MS, PBMT will 1) enhance regional muscle endurance after acute treatment and 2) enhance functional endurance after extended treatment. We will also test to determine if improvements are due to central or peripheral neuromuscular or cardiovascular mechanisms. Final, we will explore if regional PBMT can result in systemic anti-inflammatory effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Relapsing remitting MS,\n2. Independent or ambulatory with minimal aid.\n3. Must be able to move foot (ankle dorsiflexion) at least moderately forcibly against gravity (manual muscle test score 3-5)\n4. Subjects must be able to walk for 6 minutes independently with no or minimal use of an assistive device.\n\nExclusion Criteria:\n\n1. No noticeable left right ankle strength asymmetry\n2. No exacerbations (MS attacks) or immunosuppressive therapy use within the previous 6 months\n3. No concurrent infection or known cardiovascular disease including having a pacemaker; or other serious medical co-morbidity including metabolic, mitochondrial, autoimmune, diseases or other co-existing neurologic conditions.\n4. Not involved in any clinical trial or other research that could confound results.\n5. Must not be pregnant\n6. Must not have an active diagnosis of cancer'}, 'identificationModule': {'nctId': 'NCT03691766', 'briefTitle': 'Photobiomodulation Therapy in Persons With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Marquette University'}, 'officialTitle': 'Effect of Photobiomodulation Therapy on Muscle Function and Inflammation in Persons With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'HR-1710020115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Photobiomodulation Therapy', 'description': 'Experimental: Photobiomodulation Therapy comprising 640 nm, 875 nm, and 905 nm light (red lights)', 'interventionNames': ['Other: Photobiomodulation Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo device with different wavelengths of light without known physiologic effect.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Photobiomodulation Therapy', 'type': 'OTHER', 'description': 'Photobiomodulation therapy, a mix of red lights thought to improve mitochondrial function will be applied in and acute and chronic manner to test whether muscle fatigue improves in persons with MS.', 'armGroupLabels': ['Photobiomodulation Therapy']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Device with sham light source', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53201-1881', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marquette University', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marquette University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Wisconsin, Milwaukee', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}