NCT06909045

Brief 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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jan 2026

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

March 10, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

January 27, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

March 10, 2025

Last Update Submit

January 28, 2026

Conditions

Deep Brain StimulationParkinson Disease

Keywords

adaptive DBScontinue DBSaDBScDBS

Outcome Measures

Primary Outcomes (1)

  • Home PD diary

    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 Outcomes (26)

  • PD Home diary

    during six months of follow-up

  • PD Home diary

    during six months of follow-up

  • PD Home diary

    during six months of follow-up

  • PD Home diary

    during six months of follow-up

  • PD Home diary

    during six months of follow-up

  • +21 more secondary outcomes

Study Arms (2)

aDBS group

EXPERIMENTAL

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

Other: Adaptive DBS

cDBS group

ACTIVE COMPARATOR

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

Other: Continue DBS

Interventions

Adaptive DBSOTHER

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

aDBS group
Continue DBSOTHER

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.

cDBS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UZ Leuven

Leuven, Belgium

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Maastricht UMC+

Maastricht, Netherlands

NOT YET RECRUITING

HagaZiekenhuis

The Hague, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Martijn Beudel, MD, PhD

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

M. Beudel, MD, PhD

CONTACT

+31 20 566 9111closepd@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2025

First Posted

April 3, 2025

Study Start

January 27, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
It will be available two years after the results are published.

Locations

BE(1)NL(3)