Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease (CLOSE-PD)

January 28, 2026 updated by: dr. Martijn Beudel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Leuven, Belgium
        • Not yet recruiting
        • UZ Leuven
        • Sub-Investigator:
          • B. Swinnen, MD, PhD
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC
        • Principal Investigator:
          • Martijn Beudel, MD, PhD
      • Maastricht, Netherlands
        • Not yet recruiting
        • Maastricht UMC+
        • Sub-Investigator:
          • M.L.F. Janssen, MD, PhD
      • The Hague, Netherlands
        • Not yet recruiting
        • Hagaziekenhuis
        • Sub-Investigator:
          • M.F. Contarino, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: aDBS group
65 patients with Parkinson's disease will receive adaptive DBS.
Other: Adaptive DBS
The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.
Active Comparator: cDBS group
65 patients with Parkinson's disease will receive continue 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Home PD diary
Time Frame: change from baseline to six months of DBS
The primary outcome is the comparison between the aDBS group and the cDBS group of the change from baseline to six months in mean daily ON time without troublesome dyskinesia. Daily ON time without troublesome dyskinesia is measured with the PD home diary. The PD home diary is a self-reported tool for tracking motor symptoms in Parkinson's patients every 30 minutes for three days within a one-week window
change from baseline to six months of DBS

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PD Home diary
Time Frame: during six months of follow-up
ON time without troublesome dyskinesia
during six months of follow-up
MDS-UPDRS III (ON and OFF phase)
Time Frame: change from baseline to six months of DBS
Motor symptoms
change from baseline to six months of DBS
MDS-UPDRS IV
Time Frame: change from baseline to six months of DBS
Motor complication including motor fluctuations and dyskinesias
change from baseline to six months of DBS
Parkinson's Disease Questionnaire 39 (PDQ-39)
Time Frame: change from baseline to six months of DBS
Quality of life
change from baseline to six months of DBS
Dopaminergic medication usage
Time Frame: during six months of follow-up
during six months of follow-up
Montreal Cognitive Assessment (MoCA)
Time Frame: change from baseline to six months of DBS
MoCA is a cognitive screening tool for detecting and scoring cognitive impairment
change from baseline to six months of DBS
Beck Depression Inventory (BDI)
Time Frame: change from baseline to six months of DBS
Mood status
change from baseline to six months of DBS
Starkstein Apathy Scale (SAS)
Time Frame: change from baseline to six months of DBS
Apathy status
change from baseline to six months of DBS
Side effects
Time Frame: during six months of follow-up
Number and sort of side effects
during six months of follow-up
Time of DBS titration
Time Frame: during six months of follow-up
Duration of DBS titration based on the number and duration of hospital visits
during six months of follow-up
Assessor's evaluation of the ease of programming
Time Frame: after six months of follow-up
Five-point Likert scale
after six months of follow-up
Beta oscillatory activity
Time Frame: during six months of follow-up
Amount of decrease of oscillatory activity in the beta range
during six months of follow-up
DBS settings (1)
Time Frame: during six months of follow-up
Electrical energy consumption expressed by the Total electrical energy delivered (TEED)
during six months of follow-up
DBS settings (2)
Time Frame: during six months of follow-up
DBS amplitudes in mA
during six months of follow-up
DBS settings (3)
Time Frame: during six months of follow-up
Average stimulation fraction expressed as percentages
during six months of follow-up
Parkinson's Disease Sleep Scale (PDSS-2)
Time Frame: during six months of follow-up
Sleep disturbances and quality of sleep
during six months of follow-up
LFP characteristics (2)
Time Frame: during six months of follow-up
Beta power spectral density expressed as µV²/Hz
during six months of follow-up
LFP characteristics (2)
Time Frame: during six months of follow-up
Beta volatility expressed as a.u.
during six months of follow-up
Participant's evaluation of the burden of the treatment
Time Frame: after six months of follow-up
Five-point Likert scale
after six months of follow-up
Participant's satisfaction on the outcome of treatment
Time Frame: after six months of follow-up
Five-point Likert scale
after six months of follow-up
PD Home diary
Time Frame: during six months of follow-up
ON time with troublesome dyskinesia
during six months of follow-up
PD Home diary
Time Frame: during six months of follow-up
ON time without dyskinesia
during six months of follow-up
PD Home diary
Time Frame: during six months of follow-up
OFF time
during six months of follow-up
PD Home diary
Time Frame: during six months of follow-up
Asleep time
during six months of follow-up
Academic Medical Center Linear Disability Score (ALDS) (ON and OFF phase)
Time Frame: change from baseline to six months of DBS
Level of physical disability
change from baseline to six months of DBS
Time to final adjustment of the DBS settings
Time Frame: during six months of follow-up
first time point for stimulation parameters following the last adjustment of the stimulation parameters
during six months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maastricht University Medical Center
HagaZiekenhuis
Universitair Ziekenhuis Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martijn Beudel, MD, PhD, Amsterdam UMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL009220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request, IPD will be shared through restricted access via a secure online database.

IPD Sharing Time Frame

It will be available two years after the results are published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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