Adaptive versus continuous subthalamic nucleus deep brain stimulation for people with Parkinson's
Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
This project will try adaptive DBS versus regular continuous DBS in people with Parkinson's who already have Medtronic Percept STN implants to see if one gives more daily ON time without troublesome dyskinesia over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 4 sites (Leuven and 3 other locations) |
| Trial ID | NCT06909045 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with idiopathic Parkinson's who already have bilateral Medtronic Percept PC/RC STN electrodes, a reliable beta peak in at least one STN, can recognize ON/OFF motor states, speak Dutch, and can give informed consent.
Not a fit: Patients without a Percept device or a detectable beta signal, those with cognitive impairment or dementia, those unable to distinguish motor ON/OFF states, pregnant individuals, or those unable to attend required site visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, adaptive DBS could increase daily ON time without troublesome dyskinesia and reduce unnecessary stimulation, improving symptom control and possibly extending device battery life.
How similar studies have performed: Small pilot and crossover studies of aDBS have shown promising reductions in dyskinesia and stimulation time, but larger randomized, longer-duration comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leuven and 3 other locations
- UZ Leuven — Leuven, Belgium (Not_yet_recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.