Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT07139093
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing of an Interface for Synchronizing tACS-DBS With a Phase-locked-loop
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Active DBS and active tACS with different phase-lags (at least 4: 0°, 90°, 180°, 270°)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase-locking success', 'timeFrame': 'during stimulation procedure', 'description': 'The investigators will measure the temporal precision of the locking of the tACS to the DBS pulses should be seen. To this end, the tACS-DBS artifact and the triggers given from the interface device will be analysed offline in MATLAB.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deep brain stimulation', 'transcranial alternating current stimulation', 'EEG', 'synchronization', 'brain-computer interface'], 'conditions': ['Deep Brain Stimulation', 'Parkinson's Disease (PD)']}, 'descriptionModule': {'briefSummary': 'The investigators aim to test an interface to phase-lock transcranial alternating current stimulation (tACS) and deep brain stimulation (DBS) for future studies investigating the effects of different time-lags between DBS and tACS on the behavioural and neural level. To test if the interface works in patients with DBS, the investigators record EEG during synchronized tACS-DBS in several patients. The investigators hypothesize that they can apply tACS at the desired phase-lags relative to DBS pulses and confirm this with EEG measurements of the DBS and tACS artifact.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', '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\n* Epilepsy or history of seizures\n* Existence of heart pacemaker or other metal implants in the body (except DBS)\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT07139093', 'briefTitle': 'Testing of an Interface for Synchronizing tACS-DBS With a Phase-locked-loop', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Testing of an Interface for Synchronizing tACS-DBS With a Phase-locked-loop', 'orgStudyIdInfo': {'id': 'PV7207_1'}, 'secondaryIdInfos': [{'id': 'SCHW 2023/2-1', 'type': 'OTHER_GRANT', 'domain': 'German Research Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'phase-lags', 'description': 'Device: phase-lags\n\n* DBS will be applied at a fixed frequency between 15-30 Hz in one hemisphere only using the contact(s) of the clinical DBS settings. The amplitude of the electrode in the other hemisphere will be set to 0mA.\n* tACS will be applied closed-loop at the same frequency as DBS; with 4 phase lags relative to the DBS pulse (0°, 90°, 180°, 270°). tACS will be administered using the neuroConn DC-STIMULATOR PLUS.\n* EEG will be measured during this intervention with an analog (Digitimer) amplifier.', 'interventionNames': ['Device: DBS-coupled tACS']}], 'interventions': [{'name': 'DBS-coupled tACS', 'type': 'DEVICE', 'description': 'tACS will be applied in a phase-coupled manner, so that tACS and DBS are synchronized', 'armGroupLabels': ['phase-lags']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Monika Pötter-Nerger, MD', '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'}], 'overallOfficials': [{'name': 'Bettina C. Schwab, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UKE Hamburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Twente', 'class': 'OTHER'}, {'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}