NCT07485621

Brief Summary

The goal of this observational study is to assess whether deep brain stimulation (DBS) contact selection in Parkinson's disease could be informed by subcortical local field potential (LFP) recordings. The main question it aims to answer is: Aligns stimulation contact selection based on subcortical LFP recordings with clinically optimized contact selection? Participants will undergo LFP recordings that are part of standard clinical care during their routine hospital visits.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
33mo left

Started Mar 2026

Typical duration for all trials

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 Progress9%
Mar 2026Mar 2029

Study Start

First participant enrolled

March 5, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 16, 2026

Last Update Submit

March 16, 2026

Conditions

Parkinson's Disease (PD)

Keywords

Deep brain stimulationLocal field potentialsParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Alignment of contact selection

    Alignment between local field potential-based contact selection and the clinically optimized stimulation contact.

    From the first LFP recording to the last LFP recording (6 - 9 months)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease who are eligible for deep brain stimulation to treat refractory motor symptoms.

You may qualify if:

  • Voluntary written informed consent of the participant
  • At least 18 years of age at the time of signing the Informed Consent Form (ICF)
  • Diagnosis of idiopathic Parkinson's disease according to the clinical diagnostic criteria of the Movement Disorder Society (MDS)
  • Eligible for DBS to treat refractory PD motor symptoms, as based on multidisciplinary DBS screening
  • Have sufficient understanding of the Dutch and French language to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Bart Swinnen, MD, PhD

CONTACT

0032 16343044bart.swinnen@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 20, 2026

Study Start

March 5, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

BE(1)