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

Condition(s) studied

Investigational drug(s) / intervention(s)

Adaptive DBS: The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.

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.

Study 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

Primary outcome measure(s)

• Home PD diary — change from baseline to six months of DBS
  The primary outcome is the comparison between the aDBS group and the cDBS group of the change from baseline to six months in mean daily ON time without troublesome dyskinesia. Daily ON time without troublesome dyskinesia is measured with the PD home diary. The PD home diary is a self-reported tool for tracking motor symptoms in Parkinson's patients every 30 minutes for three days within a one-week window

Trial sites (4)

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