Deep Brain Stimulation Clinical Trials

Clinical trials related to Deep Brain Stimulation Procedure

Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
UZ Leuven
NOT_YET_RECRUITING
Leuven
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Maastricht UMC+
NOT_YET_RECRUITING
Maastricht
HagaZiekenhuis
NOT_YET_RECRUITING
The Hague
Contact Information
Primary
M. Beudel, MD, PhD
closepd@amsterdamumc.nl
+31 20 566 9111
Time Frame
Start Date: 2026-01-27
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 130
Treatments
Experimental: aDBS group
65 patients with Parkinson's disease will receive adaptive DBS.
Active_comparator: cDBS group
65 patients with Parkinson's disease will receive continue DBS.
Sponsors
Collaborators: HagaZiekenhuis, Universitair Ziekenhuis Leuven, Maastricht University Medical Center
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov