Trials / Recruiting
RecruitingNCT06909045
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Adaptive DBS | The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS. |
| OTHER | Continue 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. |
Timeline
- Start date
- 2026-01-27
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2025-04-03
- Last updated
- 2026-01-29
Locations
4 sites across 2 countries: Belgium, Netherlands
Source: ClinicalTrials.gov record NCT06909045. Inclusion in this directory is not an endorsement.