Testing of an Interface for Synchronizing tACS-DBS With a Phase-locked-loop

NCT07139093 | Recruiting

• 2 other identifiers: PV7207_1SCHW 2023/2-1
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Brain Stimulation; Parkinson's Disease (PD)

Keywords

deep brain stimulation; transcranial alternating current stimulation; EEG; synchronization; brain-computer interface

Outcome Measures

Primary Outcomes (1)

• Phase-locking success

  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.

  during stimulation procedure

Study Arms (1)

phase-lags

EXPERIMENTAL

Device: phase-lags * 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. * 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. * EEG will be measured during this intervention with an analog (Digitimer) amplifier.

Device: DBS-coupled tACS

Interventions

DBS-coupled tACS DEVICE

tACS will be applied in a phase-coupled manner, so that tACS and DBS are synchronized

phase-lags

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent by the patient
• Age 35 - 85
• patient groups: Parkinson's disease, essential tremor, dystonia
• \>3 months after surgery for DBS

You may not qualify if:

• Epilepsy or history of seizures
• Existence of heart pacemaker or other metal implants in the body (except DBS)
• Pregnancy

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• University of Twente: collaborator
• University of Oxford: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Study Officials

• Bettina C. Schwab, PhD

  UKE Hamburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bettina C. Schwab, PhD

CONTACT

+49 40 7410 26907; b.schwab@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active DBS and active tACS with different phase-lags (at least 4: 0°, 90°, 180°, 270°)

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

DE (1)