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

NCT06909045 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-01-29

No results posted yet for this study

Summary

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.

Conditions

  • Deep Brain Stimulation
  • Parkinson Disease

Interventions

OTHER

Adaptive DBS

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

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.

Sponsors & Collaborators

  • HagaZiekenhuis

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • Universitair Ziekenhuis Leuven

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Martijn Beudel, MD, PhD · Amsterdam UMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-27
Primary Completion
2027-02-01
Completion
2027-02-01

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909045 on ClinicalTrials.gov