Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-04-09 @ 7:20 AM
Study NCT ID:
NCT01579435
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2012-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020329', 'term': 'Essential Tremor'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System 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', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-10', 'studyFirstSubmitDate': '2012-04-05', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS', 'timeFrame': '10 minutes after the end of tDCS'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in tremor amplitude on electromyographic recordings', 'timeFrame': 'During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS'}, {'measure': 'Change from baseline in tremor amplitude on digitized tablet', 'timeFrame': 'During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS'}, {'measure': 'Change from baseline in tremor amplitude on accelerometric recording', 'timeFrame': 'During tDCS (expected average of 15 minutes) and 60 minutes after the end of tDCS'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['essential tremor', 'primary motor cortex', 'cerebellum', 'transcranial direct current stimulation', 'electrophysiology'], 'conditions': ['Essential Tremor']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to identify the cerebral mechanisms involved in these potential effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years and \\< 50 years\n* Important essential tremor (bilateral postural and/or action tremor since more than one year)\n* Normal physical and neurological examination, except for essential tremor\n* Insufficient efficiency of usual essential tremor's treatment\n* No treatment altering the cortical excitability\n* Agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential\n\nExclusion Criteria:\n\n* Cervical tremor\n* Current neurological or psychiatric illness other than essential tremor\n* Individual who is on medication which is known to lower seizure threshold\n* Previous history of seizure(s), malaise or current active epilepsy\n* Contraindication for MRI or TMS study\n* Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control\n* Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide an informed consent\n* Simultaneous participation in another clinical trial\n* Patients who are not enrolled at social security"}, 'identificationModule': {'nctId': 'NCT01579435', 'acronym': 'ELECTRE', 'briefTitle': 'Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.', 'orgStudyIdInfo': {'id': 'C11-37'}, 'secondaryIdInfos': [{'id': '2011-A01453-38', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic tDCS', 'description': '6 patients with essential tremor', 'interventionNames': ['Device: transcranial direct current stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Physiopathological tDCS', 'description': '6 patients with essential tremor', 'interventionNames': ['Device: transcranial direct current stimulation']}], 'interventions': [{'name': 'transcranial direct current stimulation', 'type': 'DEVICE', 'description': 'Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : motor cortex or cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation : motor cortex or cerebellum;', 'armGroupLabels': ['Physiopathological tDCS', 'Therapeutic tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Emmanuel Flamand-Roze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}