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

RecruitingNAAges 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT06909045 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Adaptive DBS
  • Continue DBS
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Where

4 sites
UZ Leuven
Leuven, Belgium
Amsterdam UMC
Amsterdam, Netherlands
Maastricht UMC+
Maastricht, Netherlands
HagaZiekenhuis
The Hague, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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