NCT06909045 Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
| NCT ID | NCT06909045 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Deep Brain Stimulation |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2026-01-27 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Martijn Beudel, MD, PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC
Frequently Asked Questions
Who can join the NCT06909045 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Deep Brain Stimulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06909045 currently recruiting?
Yes, NCT06909045 is actively recruiting participants. Contact the research team at closepd@amsterdamumc.nl for enrollment information.
Where is the NCT06909045 trial being conducted?
This trial is being conducted at Leuven, Belgium, Amsterdam, Netherlands, Maastricht, Netherlands, The Hague, Netherlands.
Who is sponsoring the NCT06909045 clinical trial?
NCT06909045 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Martijn Beudel, MD, PhD at Amsterdam UMC. The trial plans to enroll 130 participants.