Deep Brain StimulationNCT07139093
Testing of an Interface for Synchronizing tACS-DBS With a Phase-locked-loop
A study testing DBS-coupled tACS in people with Deep Brain Stimulation and Parkinson's Disease (PD), run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Deep Brain Stimulation, Parkinson's Disease (PD)
- What is being tested?
- DBS-coupled tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteGermany
- Study dates
- 30 Sep 2025to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Epilepsy or history of seizures
- Existence of heart pacemaker or other metal implants in the body (except DBS)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- DBS-coupled tACS
- Keywords
- deep brain stimulation, transcranial alternating current stimulation, EEG, synchronization, brain-computer interface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS-coupled tACSDevice
tACS will be applied in a phase-coupled manner, so that tACS and DBS are synchronized
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DBS-coupled tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase-locking success (delay to intended phase)
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.
Measured: during stimulation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start30 Sep 2025
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Active DBS and active tACS with different phase-lags (at least 4: 0°, 90°, 180°, 270°)
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Bettina C. Schwab, PhD, Principal investigator, UKE Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139093
- Sponsor's protocol ID
- PV7207_1
- Other IDs
- SCHW 2023/2-1
- Status last verified
- Mar 2026
- First submitted
- 17 Aug 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not compatible with ethics protocol
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of an Interface for Synchronizing tACS-DBS With a Phase-locked-loop
- ClinicalTrials.gov ID
- NCT07139093
- Acronym / sponsor ID
- PV7207_1
- Keywords
- deep brain stimulation, transcranial alternating current stimulation, EEG, synchronization, brain-computer interface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University of Twente, University of Oxford
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Active DBS and active tACS with different phase-lags (at least 4: 0°, 90°, 180°, 270°)
| Arm | Type | Receives |
|---|---|---|
| phase-lags | Experimental | Device: DBS-coupled tACSDevice: 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. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Epilepsy or history of seizures
- Existence of heart pacemaker or other metal implants in the body (except DBS)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBS-coupled tACStACS will be applied in a phase-coupled manner, so that tACS and DBS are synchronized | Device | phase-lags |
Primary outcome
Phase-locking success (delay to intended phase)
Time frame: during stimulation procedure
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. not compatible with ethics protocol
Related trials for Deep Brain Stimulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bettina C. Schwab, PhD principal investigator
UKE Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS-coupled tACS in people with Deep Brain Stimulation and Parkinson's Disease (PD), run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase-locking success (delay to intended phase) (time frame: during stimulation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.