Deep Brain Stimulation for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Overseen byKyle Mitchell, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?The objective of this research is to use advanced connectomic imaging models to identify disease-relevant axonal pathway targets for better tremor control in Parkinson's disease patients while avoiding undesirable side effects, with the goal of increasing precision and facilitating the choice of optimal DBS parameters for certain disease phenotypes. The investigators hypothesize that patient centered subthalamic nucleus deep brain stimulation of cerebellothalamic axonal pathways and pallidothalamic tract activation can provide better tremor control while avoiding worsening dyskinesias in patients with Parkinson's disease with significant tremor.

Eligibility Criteria

This trial is for Parkinson's disease patients who experience significant tremor and wish to improve it without worsening dyskinesias. Participants should be suitable candidates for deep brain stimulation (DBS) therapy.

Inclusion Criteria

With at least mild tremor on a pre-operatory MDS-UPDRS clinical scale as defined by at least 2 out of 4 resting tremor grading on MDS-UPDRS on at least one extremity

I am 18 years old or older.

Received DBS at least three months prior to the time of the study to allow for optimization of usual clinical care

+1 more

Exclusion Criteria

Not having a post-operative head CT with 1mm or smaller axial slices at least 1 week after initial lead implantation

Patients who received DBS less than three months prior to the start of the study

Participant Groups

The study tests if targeting specific brain pathways with DBS can better control tremors in Parkinson's patients. It compares no DBS, usual care DBS, and two optimized DBS methods based on advanced imaging models.

2Treatment groups

Experimental Treatment

Group I: On oral dopaminergic medicationExperimental Treatment4 Interventions

While on oral dopaminergic medication, MDS-UPDRS III (clinical scale) will be collected in different scenarios (each setting will be recorded for 20 minutes): during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized. Each participant will also wear a smartwatch (Apple watch) on each upper arm throughout the research encounter to collect total minutes with tremor, total minutes with dyskinesia, and severity of tremors and dyskinesia.

Group II: No oral dopaminergic medicationExperimental Treatment4 Interventions

While off of oral dopaminergic medication, MDS-UPDRS III (clinical scale) will be collected in different scenarios (each setting will be recorded for 20 minutes): during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized. Each participant will also wear a smartwatch (Apple watch) on each upper arm throughout the research encounter to collect total minutes with tremor, total minutes with dyskinesia, and severity of tremors and dyskinesia.