Deep Brain Stimulation for Parkinson's Disease

Overseen By Joshua Wong, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Dementia, Atypical parkinsonism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.

Are You a Good Fit for This Trial?

This trial is for Parkinson's disease patients with stable deep brain stimulation (DBS) therapy for at least 6 months, using the Boston Scientific Vercise Genus DBS System. Participants must be diagnosed by a neurologist specialized in movement disorders.

Inclusion Criteria

I have been on stable DBS therapy for at least 6 months.

I have a Boston Scientific Vercise Genus DBS System for my STN or GPi.

My Parkinson's diagnosis was confirmed by a specialist neurologist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Visit

Participants are programmed with two stimulation settings: one replicating their chronic best clinical setting, and a second incorporating the assigned patterned stimulation

1 day

1 visit (in-person)

Treatment Period 1

Participants use one of the two programmed settings for two weeks

2 weeks

1 visit (telemedicine)

Treatment Period 2

Participants switch to the alternate setting for the remaining two weeks

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patterned Stimulation

Trial Overview

The study tests the safety of different patterned DBS methods (biphasic, theta burst, multi frequency, and conventional) when used at home by people with Parkinson's who have had previous DBS to specific brain areas.

How Is the Trial Designed?

Group I: Region-Specific Frequency Alternation (fDBS) Experimental Treatment 2 Interventions

For those in the fDBS arm, the second setting will apply high-frequency stimulation to dorsal contacts (Levels 3 or 4) and low-frequency stimulation (30-60 Hz) to ventral contacts (Levels 1 or 2), while maintaining all other clinical parameters.

Group II: Nocturnal Theta Burst Stimulation (tDBS) Experimental Treatment 2 Interventions

In the tDBS arm, the second setting will deliver theta burst stimulation-six bursts per second at the therapeutic frequency-during nighttime hours, using the internal IPG clock to align with the participant's typical sleep schedule

Group III: Biphasic DBS (bDBS) Experimental Treatment 2 Interventions

For participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology