Deep Brain StimulationNCT07115394
EEG Measurements to Capture DBS-induced Electric Potentials
An observational study of Deep Brain Stimulation and Parkinson's Disease, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
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). 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
- What is being tested?
- EEG recording
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jul 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients implanted with deep brain stimulation
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
- none.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Keizers contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Monika Pötter-Nerger, PhD, +49 (0) 40 7410 - 50134, m.poetter-nerger@uke.de
About this study
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).
- Conditions
- Deep Brain Stimulation, Parkinson's Disease
- Being tested
- EEG recording
- Keywords
- deep brain stimulation, EEG, electric potential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG recordingOther
EEG will be recorded at high sampling rate
| Study group | Role | What they receive |
|---|---|---|
| EEG measurement during DBS | 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). Receives: Other: EEG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electric potential at the EEG locations
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.
Measured: during DBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start11 Jul 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115394
- Sponsor's protocol ID
- 2023-101217-BO-ff_1
- Other IDs
- 101116047, 2023
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Measurements to Capture DBS-induced Electric Potentials
- ClinicalTrials.gov ID
- NCT07115394
- Acronym / sponsor ID
- 2023-101217-BO-ff_1
- Conditions
- Deep Brain Stimulation, Parkinson's Disease
- Keywords
- deep brain stimulation, EEG, electric potential
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University of Twente
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEG measurement during DBS | – | Other: EEG recordingDifferent 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). |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with deep brain stimulation
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 (1 listed)
- none.
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 |
|---|---|---|
| EEG recordingEEG will be recorded at high sampling rate | Other | EEG measurement during DBS |
Primary outcome
Electric potential at the EEG locations
Time frame: during DBS
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Keizers contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Brain Stimulation and Parkinson's Disease, 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 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bettina C. Schwab, PhD (+49 40 7410 26907, b.schwab@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electric potential at the EEG locations (time frame: during DBS). 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 21 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.