- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07115394
- Original Trial
EEG Measurements to Capture DBS-induced Electric Potentials
August 17, 2025 updated by: Universitätsklinikum Hamburg-Eppendorf
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bettina C. Schwab, PhD
- Phone Number: +49 40 7410 26907
- Email: b.schwab@uke.de
Study Contact Backup
- Name: Thomas Keizers
- Email: t.keizers@utwente.nl
Study Locations
-
-
-
Hamburg, Germany, 20246
- Recruiting
- University Medical Center Hamburg-Eppendorf
-
Contact:
- Monika Pötter-Nerger, PhD
- Phone Number: +49 (0) 40 7410 - 50134
- Email: m.poetter-nerger@uke.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients implanted with deep brain stimulation
Description
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:
none.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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).
|
EEG will be recorded at high sampling rate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
during DBS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
August 3, 2025
First Submitted That Met QC Criteria
August 3, 2025
First Posted (Actual)
August 11, 2025
Study Record Updates
Last Update Posted (Actual)
August 21, 2025
Last Update Submitted That Met QC Criteria
August 17, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023-101217-BO-ff_1
- 101116047 (Other Grant/Funding Number: European Research Council)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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