Adaptive versus continuous subthalamic nucleus deep brain stimulation for people with Parkinson's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multicenter trial compares adaptive deep brain stimulation (aDBS) with standard continuous DBS (cDBS) in people with Parkinson disease who already have bilateral Medtronic Percept PC/RC electrodes targeting the subthalamic nucleus. Participants are programmed to cDBS at the first post-programming visit, then randomized 1:1 to remain on cDBS or switch to aDBS two weeks later, with follow-up visits at three and six months. Patients complete PD home diaries at baseline, two weeks, three months, and six months to measure daily ON time without troublesome dyskinesia, the primary outcome. Study sites include Amsterdam UMC (AMC-UvA), Maastricht UMC+, and UZ Leuven.

Why it matters

Who can join: the full rules

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.

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• UZ Leuven
  Leuven, Belgium Not yet recruiting
• Maastricht UMC+
  Maastricht, Netherlands Not yet recruiting
• HagaZiekenhuis
  The Hague, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Martijn Beudel, MD, PhD — Amsterdam UMC
• Study coordinator: M. Beudel, MD, PhD
• Email: closepd@amsterdamumc.nl
• Phone: +31 20 566 9111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.