Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease

NCT ID: NCT06909045

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-27

Study Completion Date

2027-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the CLOSE-PD study is to compare the efficacy of adaptive deep brain stimulation (aDBS) with continue deep brain stimulation (cDBS) in patients with Parkinson's disease. The main question it aims to answer is:

\- whether the change in daily mean ON time without troublesome dyskinesia in aDBS is greater than cDBS over a six-month follow-up period?

Researchers will compare aDBS to regular continue deep brain stimulation (cDBS).

Participants will:

* be set up to cDBS during the first programming visit (visit 2);
* be randomized 1:1 to aDBS or cDBS two weeks after visit 2;
* follow-up will be at three and six months after visit 2;
* complete PD Home diary at baseline, two weeks, three months and at six months after visit 2.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deep Brain Stimulation Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
double-blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

aDBS group

65 patients with Parkinson's disease will receive adaptive DBS.

Group Type EXPERIMENTAL

Adaptive DBS

Intervention Type OTHER

The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.

cDBS group

65 patients with Parkinson's disease will receive continue DBS.

Group Type ACTIVE_COMPARATOR

Continue DBS

Intervention Type OTHER

The Medtronic Percept device will be equipped with aDBS functionality (to maintain the blinding of the allocation), but this functionality will remain inactive. Participant will receive continue DBS.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adaptive DBS

The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.

Intervention Type OTHER

Continue DBS

The Medtronic Percept device will be equipped with aDBS functionality (to maintain the blinding of the allocation), but this functionality will remain inactive. Participant will receive continue DBS.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of idiopathic PD based on the UK Brain Bank criteria (Hughes et al. 1992);
* Age older than 18 years;
* Previous implantation of Medtronic PerceptTM PC/RC DBS electrodes bilateral targeting the STN;
* Optimal contact point compatible with aDBS in at least one STN;
* Reliable beta peak in at least one STN;
* Able to provide informed consent and comply with the study protocol;
* Understand the Dutch language.

Exclusion Criteria

* Legally incompetent adults;
* Patients with ongoing participation in other clinical trials involving neurological interventions;
* Inability to recognize the difference between the motor ON or OFF state;
* Mild cognitive impairment or dementia;
* Pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

HagaZiekenhuis

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Universitair Ziekenhuis Leuven

UNKNOWN

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

dr. Martijn Beudel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martijn Beudel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZ Leuven

Leuven, , Belgium

Site Status NOT_YET_RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status RECRUITING

Maastricht UMC+

Maastricht, , Netherlands

Site Status NOT_YET_RECRUITING

HagaZiekenhuis

The Hague, , Netherlands

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

M. Beudel, MD, PhD

Role: CONTACT

+31 20 566 9111

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL009220

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Psychiatry Study: Parkinson Disease
NCT02893449 COMPLETED NA