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

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: Recruiting
• Conditions: Parkinson Disease; Deep Brain Stimulation
• Intervention / Treatment: Other: Adaptive DBS; Other: Continue DBS

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: M. Beudel, MD, PhD; Phone Number: +31 20 566 9111; Email: closepd@amsterdamumc.nl

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PD Home diary	ON time without troublesome dyskinesia	during six months of follow-up
MDS-UPDRS III (ON and OFF phase)	Motor symptoms	change from baseline to six months of DBS
MDS-UPDRS IV	Motor complication including motor fluctuations and dyskinesias	change from baseline to six months of DBS
Parkinson's Disease Questionnaire 39 (PDQ-39)	Quality of life	change from baseline to six months of DBS
Dopaminergic medication usage		during six months of follow-up
Montreal Cognitive Assessment (MoCA)	MoCA is a cognitive screening tool for detecting and scoring cognitive impairment	change from baseline to six months of DBS
Beck Depression Inventory (BDI)	Mood status	change from baseline to six months of DBS
Starkstein Apathy Scale (SAS)	Apathy status	change from baseline to six months of DBS
Side effects	Number and sort of side effects	during six months of follow-up
Time of DBS titration	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	Five-point Likert scale	after six months of follow-up
Beta oscillatory activity	Amount of decrease of oscillatory activity in the beta range	during six months of follow-up
DBS settings (1)	Electrical energy consumption expressed by the Total electrical energy delivered (TEED)	during six months of follow-up
DBS settings (2)	DBS amplitudes in mA	during six months of follow-up
DBS settings (3)	Average stimulation fraction expressed as percentages	during six months of follow-up
Parkinson's Disease Sleep Scale (PDSS-2)	Sleep disturbances and quality of sleep	during six months of follow-up
LFP characteristics (2)	Beta power spectral density expressed as µV²/Hz	during six months of follow-up
LFP characteristics (2)	Beta volatility expressed as a.u.	during six months of follow-up
Participant's evaluation of the burden of the treatment	Five-point Likert scale	after six months of follow-up
Participant's satisfaction on the outcome of treatment	Five-point Likert scale	after six months of follow-up
PD Home diary	ON time with troublesome dyskinesia	during six months of follow-up
PD Home diary	ON time without dyskinesia	during six months of follow-up
PD Home diary	OFF time	during six months of follow-up
PD Home diary	Asleep time	during six months of follow-up
Academic Medical Center Linear Disability Score (ALDS) (ON and OFF phase)	Level of physical disability	change from baseline to six months of DBS
Time to final adjustment of the DBS settings	first time point for stimulation parameters following the last adjustment of the stimulation parameters	during six months of follow-up

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Maastricht University Medical Center; HagaZiekenhuis; Universitair Ziekenhuis Leuven
• Investigators: Principal Investigator: Martijn Beudel, MD, PhD, Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: adaptive DBS; aDBS; cDBS; continue DBS
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID 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