Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-03 @ 4:30 AM
Study NCT ID:
NCT03342534
Status:
TERMINATED
Last Update Posted:
2025-06-11
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of tDCS on Brain Organization and Motor Recovery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'End of funds before obtaining the planned number of patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2017-11-06', 'studyFirstSubmitQcDate': '2017-11-09', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in upper extremity Fugl-Meyer score, follow up 1', 'timeFrame': 'Difference between the week before intervention and 4 weeks after intervention', 'description': 'Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists'}, {'measure': 'Change in upper extremity Fugl-Meyer score, follow up 2', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists'}, {'measure': 'Change in Jamar dynamometer, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists'}, {'measure': 'Change in Jamar dynamometer, follow up 1', 'timeFrame': 'Difference between the week before intervention and 4 weeks after intervention', 'description': 'Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists'}, {'measure': 'Change in Jamar dynamometer, follow up 2', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists'}, {'measure': 'Change in Nine-Hole-Peg test, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.'}, {'measure': 'Change in Nine-Hole-Peg test, follow up 1', 'timeFrame': 'Difference between the week before intervention and 4 weeks after intervention', 'description': 'Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.'}, {'measure': 'Change in Nine-Hole-Peg test, follow up 2', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.'}, {'measure': 'Change in action research arm test (ARAT) score, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists'}, {'measure': 'Change in action research arm test (ARAT) score, follow up 1', 'timeFrame': 'Difference between the week before intervention and 4 weeks after intervention', 'description': 'Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists'}, {'measure': 'Change in action research arm test (ARAT) score, follow up 2', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists'}, {'measure': 'Change in Functional Independence Measure (FIM) score, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.'}, {'measure': 'Change in Functional Independence Measure (FIM) score, follow up 1', 'timeFrame': 'Difference between the week before intervention and 4 weeks after intervention', 'description': 'Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.'}, {'measure': 'Change in Functional Independence Measure (FIM) score, follow up 2', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.'}], 'primaryOutcomes': [{'measure': 'Change in upper extremity Fugl-Meyer score, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists'}], 'secondaryOutcomes': [{'measure': 'Change in EEG functional connectivity, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'EEG functional connectivity between ipsilesional motor cortex and the rest of the brain, as computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.'}, {'measure': 'Change in amplitude of motor evoked potentials, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Motor evoked potentials are obtained with single-pulse transcranial magnetic stimulation. Continuous measure expressed in microvolts, more microvolts indicate better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Neurological deficits and motor disorders are extremely common after stroke. Physical therapies can improve the autonomy of these patients, but despite an intensive stationary neurorehabilitation, severe deficits often persist. Complementary therapies that could improve recovery would therefore be very welcome.\n\nTranscranial direct current stimulation (tDCS) induces, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of certain cerebral regions. An increasing number of studies show that this modulation of brain activity can improve motor functions in patients with brain lesions and increase the effect of physical therapies. However, the "optimum" configuration of tDCS and the induced effects remain to be characterized and investigated.\n\nThe investigators therefore propose to carry out a study including a pilot phase in order to determine the most efficient tDCS setup. The optimum setup of of the pilot phase will be compared to a placebo condition in a multicentric main study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic or hemorrhagic stroke\n* ≤ 4 weeks after stroke onset\n* Paresis of upper limb with Fugl-Meyer score between 15 and 55 at study entry\n* Capable of participating during treatment sessions of 30-60 minutes\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Incapacity to understand study information or task instructions during trial.\n* New additional stroke during rehabilitation\n* Reduced vigilance or delirium\n* Severe language deficits\n* Preexisting affection of an upper limb\n* Severe spasticity or dystonia\n* Severe co-morbidities (e.g., traumatic, rheumatologic, neurodegenerative disease)\n* Pregnancy\n* Pacemaker\n* Skull breach\n* History of seizures or epilepsy\n* Metallic object in the brain\n* Other contraindication to non-invasive brain stimulation'}, 'identificationModule': {'nctId': 'NCT03342534', 'acronym': 'ESTCORM', 'briefTitle': 'Effect of tDCS on Brain Organization and Motor Recovery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke', 'orgStudyIdInfo': {'id': 'CRSII5-170985A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anodal tDCS', 'description': 'The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient.', 'interventionNames': ['Device: DC-stimulator (Neuroconn, Germany)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High definition (HD) anodal tDCS', 'description': 'A single HD anode is placed over the primary motor cortex of the stroke affected hemisphere, 4 HD cathodes are placed over the affected hemisphere around the anode.', 'interventionNames': ['Device: DC-stimulator (Neuroconn, Germany)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bihemispheric tDCS', 'description': 'The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the primary motor cortex of the contralesional hemisphere.', 'interventionNames': ['Device: DC-stimulator (Neuroconn, Germany)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'The electrodes are placed as in one of the active arms, but only a ramp up current is applied during 30 seconds and then switched off. This induces similar sensations for the patients, but no change in excitability.', 'interventionNames': ['Device: DC-stimulator (Neuroconn, Germany)']}], 'interventions': [{'name': 'DC-stimulator (Neuroconn, Germany)', 'type': 'DEVICE', 'description': 'A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.', 'armGroupLabels': ['Anodal tDCS', 'Bihemispheric tDCS', 'High definition (HD) anodal tDCS', 'Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Division of Neurorehabilitation, University Hospital of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Universitäre Neurorehabilitation, Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Adrian G Guggisberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Geneva'}, {'name': 'José Millán, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Texas - Austin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adrian Guggisberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'Clinique Romande de Readaptation', 'class': 'NETWORK'}, {'name': 'Ecole Polytechnique Fédérale de Lausanne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Médecin adjoint agrégé, assistant professor', 'investigatorFullName': 'Adrian Guggisberg', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}