Interface to synchronize transcranial alternating current stimulation (tACS) with deep brain stimulation (DBS) using a phase-locked loop.
Testing of an Interface for Synchronizing tACS-DBS With a Phase-locked-loop
NA · Universitätsklinikum Hamburg-Eppendorf · NCT07139093
This project will test a system that times noninvasive tACS to DBS pulses in people with Parkinson's disease or other DBS-treated movement disorders to see if the device can reliably deliver specific phase delays.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2 (estimated) |
| Ages | 35 Years to 85 Years |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf (other) |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT07139093 on ClinicalTrials.gov |
What this trial studies
The team will recruit patients who already have DBS implants and are at least three months post-surgery and record EEG while delivering synchronized DBS-coupled tACS using a phase-locked loop interface. The aim is to apply tACS at predefined phase lags relative to DBS pulses and confirm phase alignment by measuring DBS and tACS artifacts in the EEG. Sessions are performed on-site with real-time synchronization between the systems to verify timing accuracy and safety. Successful synchronization would enable later studies that test how different DBS-tACS timing affects brain activity and behavior.
Who should consider this trial
Good fit: Adults aged 35–85 with Parkinson's disease, essential tremor, or dystonia who have had DBS surgery more than three months ago, can give written informed consent, and do not have disqualifying implants, epilepsy, or pregnancy are ideal candidates.
Not a fit: People without DBS implants, those with cardiac pacemakers or other metal implants (except DBS), a history of seizures, or who are pregnant are not suitable and are unlikely to benefit from participation in this device-testing work.
Why it matters
Potential benefit: If successful, this interface could allow precise timing of noninvasive stimulation with DBS, enabling new protocols that might improve symptoms or reduce side effects.
How similar studies have performed: Phase-locked synchronization of tACS with DBS is largely novel in patients; prior work has shown feasibility of tACS and DBS separately and limited preclinical or bench demonstrations, but patient-phase-locked implementations are largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Epilepsy or history of seizures * Existence of heart pacemaker or other metal implants in the body (except DBS) * Pregnancy
Where this trial is running
Hamburg
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (RECRUITING)
Study contacts
- Principal investigator: Bettina C. Schwab, PhD — UKE Hamburg
- Study coordinator: Bettina C. Schwab, PhD
- Email: b.schwab@uke.de
- Phone: +49 40 7410 26907
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Deep Brain Stimulation, Parkinson', s Disease, deep brain stimulation, transcranial alternating current stimulation, EEG, synchronization, brain-computer interface