NCT07115394

Brief 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). 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Jul 2025Dec 2026

Study Start

First participant enrolled

July 11, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

August 3, 2025

Last Update Submit

August 17, 2025

Conditions

Keywords

deep brain stimulationEEGelectric potential

Outcome Measures

Primary Outcomes (1)

  • 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.

    during DBS

Study Arms (1)

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).

Other: EEG recording

Interventions

EEG will be recorded at high sampling rate

EEG measurement during DBS

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients implanted with deep brain stimulation

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:

  • none.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Central Study Contacts

Bettina C. Schwab, PhD

CONTACT

Thomas Keizers

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2025

First Posted

August 11, 2025

Study Start

July 11, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations