Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-29 @ 6:18 AM
Study NCT ID:
NCT06916260
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light Therapy Intervention in Individuals With 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': 'D010778', 'term': 'Photochemotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'There will be two groups that receive the light therapy and two that ill receive a placebo treatment to control for any possible effects of the therapy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive symptom improvement', 'timeFrame': 'Done immediately before (pre test) and after (post test) intervention lasting about 1 hour. The intervention lasts about 6 weeks, so in between the pre and post tests there will be about a 6 week period.', 'description': 'The investigators want to asses whether light therapy has a positive effect on reducing the cognitive symptoms related with PD, such as loss of short term memory, attention and processing speed. This will be measured using a set of tests and questioners (i.e MoCa, NIH cognitive battery, brief Test of attention (BTA)). Performance on these tests and questioners, which measure diverse aspects of cognition, will be compared before and after the intervention to establish if there is a positive effect of the therapy on any aspect of cognition. The intervention will last a total of 6 weeks right after the completion of the pre intervention assessment. after the completion of the 6 weeks of intervention therapy, the pre test will be conducted and cognitive measure changes will be recorded.'}, {'measure': 'motor symptoms', 'timeFrame': 'Done immediately before (pre test) and after(post test) intervention lasting about 1 hour. The intervention lasts 6 weeks, so there is about a 6 week period in between the two sessions ( pre and post)', 'description': 'The investigators want to asses whether light therapy has a positive effect on reducing the motor symptoms related with PD, such as changes in gait, tremors, and slowing of movement. This will be measured using a set of tests and questioners (i.e MDSUPDRS, Dual task walking, APDM motion capture over a set of tests). Performance on these tests and questioners, which measure diverse aspects of motor capabilities, will be compared before (pre test) and after (post tests) the intervention to establish if there is a positive effect of the therapy on any aspect of motor control and movement. The intervention will last a total of 6 weeks, done right after the completion of the pre intervention assessment. after the completion of the 6 weeks of intervention therapy, the pre test will be conducted and any changes in motor measures will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The study looks to investigate the effects that light therapy delivered to the frontal cortex could have on Parkinson's disease related symptoms ( both cognitive and motor). The therapy is a non invasive technique that deliverers low level wavelength light to the front part of the head for 12 minutes. for this study the therapy will be done 3 times a week for 6 weeks. To measure the potential effects on the therapy in Parkinson symptoms, we will do a set of cognitive and motor test before and after the intervention to measure any changes as well as control for any potential markers such as age, sex, disease level, medication and exercise."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Parkinson disease\n\nExclusion Criteria:\n\n1. Participants who are unable to comply with study visit/testing requirements (e.g.\n\n participants who cannot go off PD medication for the pre-, post-, and 3-month assessments).\n2. Participants who are unable to provide consent.\n3. Participants with a Deep Brain Stimulation (DBS) device.\n4. Participants who have a history of a psychiatric disorder\n5. Participants with PD who have other concurrent movement/neurological conditions, including dystonia, dementia, epilepsy etc.\n6. Participants with a clinical diagnosis of PD that is not considered primary (e.g.\n\n vascular parkinsonism) or participants where an atypical form of parkinsonism is suspected (e.g., progressive supranuclear palsy, multiple system atrophy).\n7. Participants with a history of cancer (whether treated with chemotherapy and/or radiotherapy or not).\n8. Participants with a history of a recent concussion or any facial, neck, or head injury within the last 6 months. UD IRB Approved: 03/12/2025 IRBNet ID#: 2277769-2 I/C from Rev. 01/2024 Page 3 of 10 Participant's Initial's \\_\\_\\_\\_\\_\\_\\_\\_\n9. Known injury or disease that might interfere with motor function in the proposed experiments (e.g., stroke, traumatic brain injury, extrapyramidal dysfunction, neuromuscular disease, orthopedic problems that impair movement).\n10. Participants with a history of photosensitivity.\n11. Participants who are not able to walk unassisted for 2 minutes"}, 'identificationModule': {'nctId': 'NCT06916260', 'briefTitle': "Light Therapy Intervention in Individuals With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': "Light Therapy Intervention in Individuals With Parkinson's Disease", 'orgStudyIdInfo': {'id': '2277769'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Light therapy grpup', 'interventionNames': ['Device: Red Light (PDT)']}, {'type': 'SHAM_COMPARATOR', 'label': 'placebo light therapy', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Red Light (PDT)', 'type': 'DEVICE', 'description': 'The intervention is a non invasive and safe practice. By delivering low level wavelength red light to the front part of the head, it can increase blood flow in the area treated and improve functioning of the associated regions, potentially improving symptoms.', 'armGroupLabels': ['Light therapy grpup']}, {'name': 'Placebo', 'type': 'DEVICE', 'description': 'The intervention is a non invasive and safe practice. Participants will be wearing a helmet that delivered low level light therapy to the brain, and use it for the same amount of time as the treatment group. These participants will however, not receive the actual light and receive a placebo, so the helmet will be off. This is done to control of any potential positive effects of the therapy.', 'armGroupLabels': ['placebo light therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19711', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Penuela, PhD Student', 'role': 'CONTACT', 'email': 'penuelas@udel.edu', 'phone': '973-974-0120'}, {'name': 'John Jeka, PdD', 'role': 'CONTACT', 'email': 'jjeka@udel.edu'}, {'name': 'sara Penuela, PhD student', 'role': 'SUB_INVESTIGATOR'}, {'name': 'John Jeka, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Roxana Burciu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thomas Buckley, PhED', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Delaware STAR Tower', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'centralContacts': [{'name': 'Sara Penuela, PhD student', 'role': 'CONTACT', 'email': 'penuelas@udel.edu', 'phone': '9739740120'}, {'name': 'Roxana Burciu, PhD, Associative Professor', 'role': 'CONTACT', 'email': 'rgburciu@udel.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeuroThera', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}