RecruitingNot ApplicableNCT06909045

Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease

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


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

130 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of deep brain stimulation (DBS) — a technique where a device implanted in the brain sends electrical signals to control movement — to see if an "adaptive" approach that adjusts in real time works better than continuous stimulation for Parkinson's disease. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with idiopathic Parkinson's disease - You already have a specific Medtronic Percept DBS device implanted targeting the subthalamic nucleus (STN) on both sides - Your device shows a reliable brain signal pattern (beta peak) that can guide the adaptive stimulation - You understand Dutch and can follow the study protocol **You may NOT be eligible if...** - You are legally incapacitated - You are enrolled in another clinical trial involving neurological interventions - You have mild cognitive impairment or dementia - You are pregnant - You cannot tell the difference between your ON and OFF motor states Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAdaptive DBS

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

OTHERContinue 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.


Locations(4)

UZ Leuven

Leuven, Belgium

Amsterdam UMC

Amsterdam, Netherlands

Maastricht UMC+

Maastricht, Netherlands

HagaZiekenhuis

The Hague, Netherlands

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NCT06909045


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