Clinical Trials Directory

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

TypeNameDescription
OTHERAdaptive DBSThe Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.
OTHERContinue DBSThe 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.