Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
Study NCT ID:
NCT06883266
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2025-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD
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': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The participant and their care provider will be blinded as to which intervention is being used.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to an experimental group (receives stimulation) or a sham group (is set up with tDCS, but no stimulation is received)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Finger and Toe-Tapping on KinesiaOne Device', 'timeFrame': '30 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session', 'description': 'We will use the KinesiaOne measure the finger tapping and foot tapping for 15 seconds. It will repeat 3 times at 1 minute intervals. KinesiaOne is a light-weight device that can be attached to the Index finger or ankle. It measures the acceleration and deceleration of the finger or foot. The measurement is transmitted to the KinesiaOne tablet that allows further data processing.'}], 'secondaryOutcomes': [{'measure': 'Montreal Cognitive Assessment (MOCA)', 'timeFrame': '8 minutes; pre-test during the second research visit.', 'description': 'This is a tool used to screen for mild cognitive dysfunctions. It assesses different domains of cognition: attention, memory, language visuospatial skills, orientation, and calculations. It determines the cut-off for dementia.'}, {'measure': 'The Multidimensional Fatigue Inventory (MFI)', 'timeFrame': '5 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session', 'description': 'This is a 20-item self-report instrument that measures five dimensions of fatigue independently: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity.'}, {'measure': 'Center for Epidemiological Studies Depression Scale (CES-D).', 'timeFrame': '5 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session', 'description': 'This is a tool used to screen for symptoms of depression.'}, {'measure': 'McGill Quality of Life (QOL) Scale', 'timeFrame': '1 minute; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session', 'description': 'This is a single item tool to assess quality of life on all parts of life (physical, emotional, social, spiritual, and financial.'}, {'measure': 'MDS-UPDRS Part II (patient self-report)', 'timeFrame': '10 minutes; pre-test during the second research visit, post-test on 6th research visit after 5 consecutive days of tDCS, a follow up test on the 7th research visit, 7 days after last tDCS session and 8th visit 14 days after last tDCS session', 'description': 'This is a 20-item patient self-report questionnaire that assess the motor aspects of experiences of daily living.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Parkinsons Disease', 'tDCS', 'Motor Function', 'Motor Fatigue'], 'conditions': ['Parkinsons Disease (PD)']}, 'referencesModule': {'references': [{'pmid': '22037126', 'type': 'BACKGROUND', 'citation': 'Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left dorsolateral prefrontal cortex (LDLPFC) will induce long-lasting effects in improving motor function and reducing motor fatigue and fatigability in PD patients.', 'detailedDescription': 'Parkinson\'s disease (PD) is the fastest growing and second most common neurodegenerative disease (after Alzheimer\'s disease) and affects approximately one million people in the United States. Impaired motor function is one of the cardinal features of PD. One of the diagnostic criteria for PD is bradykinesia (slowness of movement). In addition to bradykinesia, PD patients also suffer from increased motor fatigue and motor fatigability. In the body of fatigue research, the term "motor fatigue\' usually refers to the general sensation of tiredness or of difficulty in initiating physical activity experienced over several days to weeks. This is often assessed by questionnaires completed by the subject. The term \'motor fatigability\' refers to difficulty in maintaining physical activity at a desired level (Lou, 2009). This is often assessed quantitively in a laboratory setting. Motor impairments, motor fatigue, and motor fatigability affect quality of life in patients with Parkinson\'s disease.\n\nTranscranial direct current stimulation (tDCS) is a noninvasive and safe brain stimulation technique that has been shown to be effective in improving motor function in subjects with Parkinson\'s disease. During tDCS, low-voltage, low amplitude current is passed through a pair of surface electrodes placed over the areas of brain of interest.\n\nThe specific aim of this study is to examine if atDCS to LDLPFC at 2 milliamps (mA) for 20 minutes daily for 5 days will improve motor function and reduce motor fatigue and fatigability in PD patients. The study will examine if the effects may last for two weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability)\n* Must be able to consent\n\nExclusion Criteria:\n\n* Patients with dementia (MOCA \\< 21)\n* PD treatment using deep brain stimulation (DBS)\n* Diagnosis of psychosis\n* Diagnosis of multiple sclerosis\n* Diagnosis of stroke\n* Diagnosis of chronic obstructive pulmonary disease (COPD)\n* Diagnosis of congestive heart failure (CHF)'}, 'identificationModule': {'nctId': 'NCT06883266', 'acronym': 'tDCS', 'briefTitle': 'Transcranial Direct Current Stimulation for Motor Function and Fatigue in PD', 'organization': {'class': 'OTHER', 'fullName': 'Sanford Health'}, 'officialTitle': "Transcranial Direct Current Stimulation (tDCS) to Improve Motor Function and Motor Fatigue in Parkinson's Patients", 'orgStudyIdInfo': {'id': 'SH tDCS-Motor-PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'The experimental group will receive 2mA of anodal transcranial direct current stimulation (tDCS) for 20 minutes daily for 5 consecutive days.', 'interventionNames': ['Device: transcranial direct current stimulation (tDCS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group', 'description': 'The sham group will be connected to the anodal transcranial direct current stimulation device daily for 5 days. During the 20 minute sessions, the participant will only receive stimulation for a 30-second ramp up period, at which point the stimulation will be discontinued for the remainder of the time.', 'interventionNames': ['Device: Sham (No Treatment)']}], 'interventions': [{'name': 'transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'description': '2 mA will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Sham (No Treatment)', 'type': 'DEVICE', 'description': 'For 30 seconds, the patient will experience a ramp up of the stimulation, after which point no stimulation will be transmitted for the remainder of the session. This will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex', 'armGroupLabels': ['Sham Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Keller, B.S.', 'role': 'CONTACT', 'email': 'jessica.keller@sanfordhealth.org', 'phone': '701-417-5781'}, {'name': 'Jau-Shin Lou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sanford Brain and Spine Center', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}], 'centralContacts': [{'name': 'Jessica Keller, B.S.', 'role': 'CONTACT', 'email': 'jessica.keller@sanfordhealth.org', 'phone': '701-417-5781'}], 'overallOfficials': [{'name': 'Jau-Shin Lou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sanford Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanford Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}