Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-03-05 @ 6:58 PM
Study NCT ID:
NCT03759132
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2018-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Transcranial Direct Current Stimulation on Postural Control
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2018-11-21', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse effects', 'timeFrame': 'Immediately after tDCS', 'description': 'Adverse effects will be evaluated using structured questionnaire'}], 'primaryOutcomes': [{'measure': 'Change from COP - AP axis', 'timeFrame': 'Baseline and Post-tDCS (immediately after tDCS)', 'description': 'Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters.'}, {'measure': 'Change from COP - ML axis', 'timeFrame': 'Baseline and Post-tDCS (immediately after tDCS)', 'description': 'Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters.'}, {'measure': 'Change from COP - area', 'timeFrame': 'Baseline and Post-tDCS (immediately after tDCS)', 'description': 'Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Recent evidence has demonstrated the potential use of transcranial direct current stimulation (tDCS) to modulate cerebral excitability and movement control in neurological chronic conditions. However, few studies have investigated the effects of tDCS on postural control in patients with Parkinson's disease. This study aims to investigate the effect of bihemispheric tDCS on postural control in people with Parkinson's disease. Participants will be randomized to receive a single session of anodal and sham bihemispheric tDCS (7 days between each type of stimulation).\n\nPrimary clinical outcome (balance) will be collected before and immediately after tDCS. The data will be collected by a blind examiner to the treatment allocation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nMedical diagnosis of idiopathic Parkinson's disease present for at least 12 months\n\nIn clinical follow-up and pharmacological treatment by a responsible physician\n\nParkinson's classification of 1.5-3 according to the Hoehn and Yahr scale\n\nSigning of the free and informed consent form-\n\nExclusion Criteria:\n\nUse any associated orthopedic device to aid gait or balance control\n\nSigns of severe dementia (evaluated by the Mini-Mental State Examination - MMSE)\n\nDiagnosis of other neurological disorders (including those of central and peripheral nature)\n\nPrevious treatment with tDCS\n\nMedical diagnosis of psychiatric illnesses with the use of centrally acting medications (depressants)\n\nThe use of pacemakers or other implanted devices.-"}, 'identificationModule': {'nctId': 'NCT03759132', 'briefTitle': 'Effects of Transcranial Direct Current Stimulation on Postural Control', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Piauí'}, 'officialTitle': 'Effects of Transcranial Direct Current Stimulation on Postural Control: a Double-blind Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': "tDCS in Parkinson's Disease"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anodal tDCS', 'description': 'Bihemispheric tDCS applied over primary motor cortex.\n\nDose: 2mA, 20 minutes', 'interventionNames': ['Procedure: Transcranial direct current stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'Bihemispheric tDCS applied over primary motor cortex.\n\nDose: 2mA, 20 minutes (30s ON)', 'interventionNames': ['Procedure: Transcranial direct current stimulation']}], 'interventions': [{'name': 'Transcranial direct current stimulation', 'type': 'PROCEDURE', 'description': "Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different chronic neurological conditions, including Parkinson's disease.", 'armGroupLabels': ['Anodal tDCS', 'Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64202020', 'city': 'Parnaíba', 'state': 'Piauí', 'country': 'Brazil', 'facility': 'Department of Physical Therapy. Federal University of Piaui', 'geoPoint': {'lat': -2.90472, 'lon': -41.77667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Piauí', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor - Physical Therapy Department', 'investigatorFullName': 'Fuad Ahmad Hazime', 'investigatorAffiliation': 'Universidade Federal do Piauí'}}}}