Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT07115394
Status:
RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EEG Measurements to Capture DBS-induced Electric Potentials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-17', 'studyFirstSubmitDate': '2025-08-03', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electric potential at the EEG locations', 'timeFrame': 'during DBS', 'description': 'The investigators will extract the DBS pulses from the EEG data and check the distribution of the electric potentials as seen in simulations based on individual MRI and CT images. Parameters of the simulation pipeline (e.g. conductances) will be adjusted so that the simulation models fit the data.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deep brain stimulation', 'EEG', 'electric potential'], 'conditions': ['Deep Brain Stimulation', 'Parkinson's Disease']}, 'descriptionModule': {'briefSummary': 'To measure the electric fields induced by DBS (deep brain stimulation) on the scalp and to improve electric field simulations, the investigators will measure EEG (electroencephalography) measurements with high sampling rates (\\>100 kHz). The investigators hypothesize that we can improve electric field simulations of DBS by validating and calibrating the simulations based on EEG measurements at high sampling rates (\\>100 kHz).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients implanted with deep brain stimulation', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of written informed consent by the patient\n* Age 35 - 85\n* patient groups: Parkinson's disease, essential tremor, dystonia\n* \\>3 months after surgery for DBS\n\nExclusion Criteria:\n\nnone."}, 'identificationModule': {'nctId': 'NCT07115394', 'briefTitle': 'EEG Measurements to Capture DBS-induced Electric Potentials', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'EEG Measurements to Capture DBS-induced Electric Potentials', 'orgStudyIdInfo': {'id': '2023-101217-BO-ff_1'}, 'secondaryIdInfos': [{'id': '101116047', 'type': 'OTHER_GRANT', 'domain': 'European Research Council'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'EEG measurement during DBS', 'description': 'Different DBS conditions can include the individual bilateral therapeutical DBS settings, unilateral versions of these setting, unilateral single segment use of these settings or unilateral low frequency (15-30 Hz) DBS. EEG measurements with a 4-channel analog EEG amplifier (Digitimer EEG).', 'interventionNames': ['Other: EEG recording']}], 'interventions': [{'name': 'EEG recording', 'type': 'OTHER', 'description': 'EEG will be recorded at high sampling rate', 'armGroupLabels': ['EEG measurement during DBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Monika Pötter-Nerger, PhD', 'role': 'CONTACT', 'email': 'm.poetter-nerger@uke.de', 'phone': '+49 (0) 40 7410 - 50134'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Bettina C. Schwab, PhD', 'role': 'CONTACT', 'email': 'b.schwab@uke.de', 'phone': '+49 40 7410 26907'}, {'name': 'Thomas Keizers', 'role': 'CONTACT', 'email': 't.keizers@utwente.nl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Twente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}