LFP-based Parameter Prediction in DBS for Parkinson's Dis... | NCT07485621

Studies
LFP-based Parameter Prediction in DBS for Parkinson's Disease

NCT07485621

Sponsor

Loes Laurijssen

Status

Recruiting

Last Update Posted

Mar 20, 2026Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Parkinson's Disease (PD)

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2026Actual

Primary Completion Date

Mar 2029Estimated

Completion Date

Mar 2029Estimated

First Submitted Date

Mar 16, 2026

First Submission Date that Met QC Criteria

Mar 16, 2026

First Posted Date

Mar 20, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bart Swinnen, MD, PhD	Contact	0032 16343044		bart.swinnen@uzleuven.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Leuven	Recruiting	Leuven	Vlaams-Brabant	3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided