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Procedure

Deep Brain Stimulation for Parkinson's Disease

N/A

Waitlist Available

Led By Kyle Mitchell, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Diagnosed with Parkinson's disease and has previously been implanted with bilateral subthalamic nucleus deep brain stimulation (DBS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately eight hours

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use advanced imaging techniques to find specific brain pathways that can be targeted to improve tremor control in Parkinson's disease patients. The goal is to enhance treatment precision and help doctors choose the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, headache, confusion or difficulty concentrating, speech problems, balance issues, and unwanted movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have Parkinson's and have a DBS device implanted in my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately eight hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately eight hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately eight hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dyskinesia duration as measured by wearables

Dyskinesia severity as measured by wearables

Tremor duration as measured by wearables

+1 more

Secondary study objectives

Tremor severity as measured by the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met