Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-09 @ 1:28 PM
Study NCT ID:
NCT04195412
Status:
UNKNOWN
Last Update Posted:
2019-12-11
First Post:
2019-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging the Effects of Bihemispheric Transcranial Stimulation and Motor Training After Stroke.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-related changes in functional magnetic resonance imaging', 'timeFrame': 'pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)', 'description': 'Brain functional changes from baseline to post-treatment'}, {'measure': 'Treatment-related changes in white matter', 'timeFrame': 'pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)', 'description': 'Brain structural (white matter) changes from baseline to post-treatment'}], 'secondaryOutcomes': [{'measure': 'Changes in Fugl-Meyer assessment of paretic upper limb motor function', 'timeFrame': 'pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment); 30 days follow up (30 days after completing treatment) and 90 days follow up (90 days after completing treatment)', 'description': 'Fugl-Meyer Upper Extremity (FM-UE) Scale of Motor Impairment scores changes from baseline to post-treatment, 30 and 90 days later (follow up).'}, {'measure': 'Changes in Jebsen-Taylor Hand Function Test scores', 'timeFrame': 'pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days', 'description': 'Fugl-Meyer Upper Extremity (FM-UE) Scale of Motor Impairment scores changes from baseline to post-treatment and in subsequent follow-up'}, {'measure': 'Changes in Stroke Impact Scale scores', 'timeFrame': 'pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days', 'description': 'Stroke Impact Scale scores changes from baseline to post-treatment and in subsequent follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke Rehabilitation', 'Transcranial Direct Current Stimulation', 'Neuroimaging', 'Neuronal Plasticity'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Functional and structural magnetic resonance imaging (MRI) will be used to investigate neural correlates of bihemispheric transcranial direct current stimulation (tDCS) associated with upper limb rehabilitation in chronic stroke patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individualized rehabilitation. Neuroimage will be employed before and after the intervention to investigate neural correlates of expected changes in motor function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Stroke (\\> 12 months)\n* Upper limb sensorimotor sequelae due to stroke affecting only one cerebral hemisphere\n* The structural integrity of the corpus callosum sensorimotor\n* Showing ability to perform some movement with the paretic upper limb: at least minimal active mobility of the wrist and two fingers of the paretic hand.\n* Score ≥ 18 at Folstein Mini-Mental State Examination\n\nExclusion Criteria:\n\n* Score ≥ 4 at Ashworth Scale\n* MRI or tDCS contraindications (cardiac pacemakers; implanted medication pumps; cochlear, or eye implants; craniotomy, skin lesions at the site of stimulation; surgical clips in or near the brain; claustrophobia, history of seizures, permanent makeup or tattoos with metallic dyes…)\n* Prior neurological diseases\n* Hemodynamic instability\n* Pregnancy\n* Traumatic or orthopedic lesion limiting the range of upper limb motion\n* Severe comprehension deficits, apraxia or neglect that would interfere with performing the study tasks\n* Score \\> 59 at the Fugl-Meyer Assessment of Motor Recovery after Stroke'}, 'identificationModule': {'nctId': 'NCT04195412', 'briefTitle': 'Imaging the Effects of Bihemispheric Transcranial Stimulation and Motor Training After Stroke.', 'organization': {'class': 'OTHER', 'fullName': "D'Or Institute for Research and Education"}, 'officialTitle': 'Neuroplasticity Following Bihemispheric Transcranial Direct Current Stimulation and Motor Training in Chronic Stroke Patients.', 'orgStudyIdInfo': {'id': 'PRJ1913'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS', 'description': 'Bihemispheric tDCS will be applied. The anode will be placed on the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. After stimulation, individual and intensive upper limb rehabilitation will be performed.', 'interventionNames': ['Device: tDCS + upper limb rehabilitation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Bihemispheric sham tDCS will be applied. The anode will be placed on the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. After sham stimulation, individual and intensive upper limb rehabilitation will be performed.', 'interventionNames': ['Device: Sham tDCS + upper limb rehabilitation']}], 'interventions': [{'name': 'tDCS + upper limb rehabilitation', 'type': 'DEVICE', 'description': 'Stimulation will be applied for 20 minutes by a DC stimulator (NeuroConn, Germany). During each stimulation section, a pair of saline-soaked sponge electrodes (surface 24 cm²) will be placed over C3 and C4, according to the International 10-20 EEG system. Stimulation intensity will be 2 mA with current ramping up and down of 10 seconds each. The stimulation will be followed by 40 minutes of upper limb rehabilitation. Experimental sessions will be repeated five times per week to complete 10 sessions.', 'armGroupLabels': ['tDCS']}, {'name': 'Sham tDCS + upper limb rehabilitation', 'type': 'DEVICE', 'description': 'Sham stimulation will be applied for 20 minutes by a DC stimulator (NeuroConn, Germany). During each sham stimulation section, a pair of saline-soaked sponge electrodes (surface 24 cm²) will be placed over C3 and C4, according to the International 10-20 EEG system. The anode will be placed to the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. Sham tDCS will be performed by ramping current flow for the first 10 seconds of stimulation, but switching the stimulator off automatically after 30 seconds. The sham stimulation will be followed by 40 minutes of upper limb rehabilitation. Experimental sessions will be repeated five times per week to complete 10 sessions.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22281100', 'city': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Erika C Rodrigues, PhD', 'role': 'CONTACT', 'email': 'erika.rodrigues@idor.org', 'phone': '552138836000'}], 'facility': "D'Or Institute for Research and Education (IDOR)", 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'centralContacts': [{'name': 'Erika C Rodrigues, PhD', 'role': 'CONTACT', 'email': 'erika.rodrigues@idor.org', 'phone': '+552138836000'}], 'overallOfficials': [{'name': 'Fernanda F Tovar-Moll, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "D'Or Institute for Research and Education (IDOR)"}, {'name': 'Erika C Rodrigues, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "D'Or Institute for Research and Education (IDOR)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "D'Or Institute for Research and Education", 'class': 'OTHER'}, 'collaborators': [{'name': 'Rio de Janeiro State Research Supporting Foundation (FAPERJ)', 'class': 'OTHER_GOV'}, {'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}