Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-01 @ 5:21 AM
Study NCT ID:
NCT02782533
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DBS of the Third Ventricle for Cluster Headache and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life Questionnaire', 'timeFrame': 'weekly up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cluster Headache', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Male or female aged between 18 and 65 years\n* Ambulatory or hospitalized monitoring\n* Fluent in French and able to understand the study procedures, including completing the auto-questionnaires\n* Registered in the French social security scheme\n* Signed informed consent of the patient will be collected before inclusion in the study\n* Cluster Headache or Obesity patients\n\nExclusion Criteria:\n\n* Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)\n* Contraindication to Magnetic resonance imaging (MRI)\n* All categories of protected persons'}, 'identificationModule': {'nctId': 'NCT02782533', 'acronym': 'DBS V3', 'briefTitle': 'DBS of the Third Ventricle for Cluster Headache and Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'orgStudyIdInfo': {'id': 'CHU Grenoble'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DBS V3', 'description': 'Deep Brain Stimulation V3', 'interventionNames': ['Device: Deep Brain Stimulation V3']}], 'interventions': [{'name': 'Deep Brain Stimulation V3', 'type': 'DEVICE', 'armGroupLabels': ['DBS V3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CLINATEC', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}