Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Adaptive DBS
  • Continue DBS

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead sponsor

HagaZiekenhuis

Collaborator

Maastricht University Medical Center

Collaborator

Universitair Ziekenhuis Leuven

Collaborator