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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form and comply with the study protocol; - Understand the Dutch language. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (4)

UZ Leuven
Leuven, Belgium
Amsterdam UMC
Amsterdam, Netherlands
Maastricht UMC+
Maastricht, Netherlands
HagaZiekenhuis
The Hague, Netherlands