Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT07271927
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Whole-Body Photobiomodulation for Motor and Cognitive Changes in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UPDRS', 'timeFrame': 'Change in UPDRS from baseline to post 30 sessions (up to approximately 10 weeks). The UPDRS ranges from 0 to 199, with higher scores indicating greater symptom severity.', 'description': "Unified Parkinson's Disease Rating Scale"}], 'secondaryOutcomes': [{'measure': 'BBS', 'timeFrame': 'Change in Berg Balance Scale scores from baseline to post 30 sessions (up to approximately 10 weeks). The BBS ranges from 0 to 56, with higher scores indicating better balance performance.', 'description': 'Berg Balance Scale'}, {'measure': 'Grip strength and pinch strength test', 'timeFrame': 'Change in Grip strength and pinch strength from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.', 'description': 'Grasp, tip pinch \\& three jaw chuck'}, {'measure': 'FRT', 'timeFrame': 'Change in Functional Reach Test scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.', 'description': 'Functional Reach Test'}, {'measure': 'TUG', 'timeFrame': 'Change in Timed Up and Go test scores from baseline to post 30 sessions (up to approximately 10 weeks). Lower scores indicate better functional mobility.', 'description': 'Timed Up and Go'}, {'measure': 'CTRS', 'timeFrame': 'Change in CRTS scores from baseline to post 30 sessions (up to approximately 10 weeks). The score ranges from 0 to 160, with higher scores indicating more severe tremor symptoms.', 'description': 'Clinical Rating Scale for Tremor'}, {'measure': 'SVLT', 'timeFrame': 'Change in SVLT scores from baseline to post 30 sessions (up to approximately 10 weeks). The scores ranging from 0 to 36, where higher scores reflect better memory performance.', 'description': 'Seoul verbal learning test'}, {'measure': 'RCFT', 'timeFrame': 'Change in RCFT scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better visuospatial and memory performance.', 'description': 'Rey complex figure test'}, {'measure': 'DST', 'timeFrame': 'Change in DST scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better performance.', 'description': 'Digit span test'}, {'measure': 'TMT', 'timeFrame': 'Change in TMT scores from baseline to post 30 sessions (up to approximately 10 weeks). Faster completion times (i.e., lower scores) indicate better cognitive function.', 'description': 'Trail making test'}, {'measure': 'K-CWST', 'timeFrame': 'Change in K-CWST scores from baseline to post 30 sessions (up to approximately 10 weeks). Faster completion times (i.e., lower scores) indicate better cognitive function.', 'description': 'Korean-Color word stroop test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Photobiomodulation', 'Parkinson disease', 'cognition', 'motor function', 'light theraphy'], 'conditions': ['PARKINSON DISEASE (Disorder)']}, 'descriptionModule': {'briefSummary': "This study aims to exploratorily evaluate the extent of motor and cognitive changes, as well as the safety, resulting from approximately 10 weeks of whole-body photobiomodulation (PBM) therapy (about three sessions per week, once daily, 20 minutes per session) in patients with Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals diagnosed with Parkinson's disease at Hoehn and Yahr stages 1-3 based on medical history and examination\n* Adults aged 40 years or older\n* Individuals able to walk independently\n\nExclusion Criteria:\n\n* Individuals with severe cognitive impairment (Korean Mini-Mental State Examination \\[K-MMSE\\] score ≤ 9) making it difficult to understand and perform tasks\n* Patients with dementia other than Parkinson's disease dementia\n* Individuals with implanted medical or other electronic devices\n* Individuals with severe neuropsychiatric disorders\n* Individuals treated for alcohol dependence within 6 months prior to screening\n* Individuals with a history of suicide attempts\n* Individuals with a history of seizures\n* Individuals experiencing dyspnea while sitting at rest\n* Individuals with visual impairment preventing them from reading ordinary text even with corrective lenses\n* Individuals with hearing impairment preventing them from understanding conversation even with a hearing aid\n* Individuals who have participated in two or more clinical trials in the same year or in another clinical trial within the past 6 months\n* Women and men of childbearing potential who are planning pregnancy during the trial or who do not agree to use appropriate contraceptive methods\n* Pregnant or breastfeeding women\n* Individuals deemed medically inappropriate for participation by the principal investigator or study staff based on clinically significant findings not otherwise specified above"}, 'identificationModule': {'nctId': 'NCT07271927', 'acronym': 'PBM', 'briefTitle': "Whole-Body Photobiomodulation for Motor and Cognitive Changes in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': "Evaluation Study of the Effects and Safety of Whole-Body Photobiomodulation Therapy on Motor and Cognitive Changes in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': '23-2024-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parkinson', 'description': 'Participants received whole-body PBM therapy once daily (20 minutes per session), three times per week, for approximately 10 weeks, totaling 30 sessions.', 'interventionNames': ['Device: Photobiomodulation']}], 'interventions': [{'name': 'Photobiomodulation', 'type': 'DEVICE', 'description': 'Participants received whole-body PBM therapy over approximately 10 weeks (three sessions per week, once daily, 20 minutes per session), with each session using a randomly selected wavelength of either 660 nm, 850 nm, or 940 nm (±20%).', 'armGroupLabels': ['Parkinson']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Youjin Jeong', 'role': 'CONTACT', 'email': 'gamza33@naver.com', 'phone': '+82-55-360-4720'}], 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'centralContacts': [{'name': 'Jisoo Baik', 'role': 'CONTACT', 'email': 'zisoo@pusan.ac.kr', 'phone': '082+055-360-4159'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual participant data (IPD) cannot be shared due to protection of participants' personal information and regulatory restrictions of our hospital."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yong-il Shin', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}