CLOSE-PD

Randomized Controlled Trial Comparing Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease. - CLOSE-PD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57970

Enrollment

115

Registered

2025-02-05

Start date

2026-01-27

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson’s Disease, Deep Brain Stimulation (DBS), Adaptive DBS, Continue DBS Parkinson’s Disease, Deep Brain Stimulation (DBS), Automatically adjustable DBS, Fixed-parameter DBS

Interventions

In the aDBS group, participants will have their devices programmed to adjust stimulation in real-time based on LFP’s recorded from the implanted DBS electrodes. In de cDBS group, participants will rec

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of idiopathic Parkinson’s disease based on the UK Brain Bank criteria;- 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

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. 

Design outcomes

Primary

Measure	Time frame
The primary endpoint is to assess whether the change in daily mean ON time without troublesome dyskinesia in aDBS is greater than cDBS over a six-month follow-up period. ON time without troublesome dyskinesia will be measured by the use of self-completed ‘ON/OFF’ diary assessments of motor function (PD home diary) at baseline and around six to eight months follow-up after the first DBS programming visit.	—

Measure

Time frame

The primary endpoint is to assess whether the change in daily mean ON time without troublesome dyskinesia in aDBS is greater than cDBS over a six-month follow-up period. ON time without troublesome dyskinesia will be measured by the use of self-completed ‘ON/OFF’ diary assessments of motor function (PD home diary) at baseline and around six to eight months follow-up after the first DBS programming visit.

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Secondary

Measure	Time frame
Secondary outcomes are to compare the outcome of STN DBS for PD using aDBS with the outcome using cDBS, regarding: MDS-UPDRS Part III and IV scores, ALDS, PDQ-39, dopaminergic medication usage, MoCA, BDI, SAS, PDSS-2, nature and number of side effects, DBS titration time, ease of programming, beta oscillatory activity, stimulation parameters, local field potential (LFP) characteristics, and evaluation of treatment burden and participant satisfaction.	—

Measure

Time frame

Secondary outcomes are to compare the outcome of STN DBS for PD using aDBS with the outcome using cDBS, regarding: MDS-UPDRS Part III and IV scores, ALDS, PDQ-39, dopaminergic medication usage, MoCA, BDI, SAS, PDSS-2, nature and number of side effects, DBS titration time, ease of programming, beta oscillatory activity, stimulation parameters, local field potential (LFP) characteristics, and evaluation of treatment burden and participant satisfaction.

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Countries

Belgium, Netherlands

Contacts

Public ContactM. Beudel

Amsterdam UMC

closepd@amsterdamumc.nl+31 (0)20 566 9111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 7, 2026