Deep Brain Stimulation Adjustments for Parkinson's Disease

(FREQUENCY Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Darlene Floden

Disqualifiers: Other CNS disease, Dementia, Substance abuse, others

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

Compensation: Varies

Number of Visits: 1

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).

Who Is on the Research Team?

Darlene Floden, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for Parkinson's patients aged 40-70 who've had Deep Brain Stimulation (DBS) for at least 3 months. They must be diagnosed by a specialist, have had the disease for over 4 years, and can consent to participate. Those with previous brain surgeries for PD, other CNS diseases, severe psychiatric symptoms or dementia, substance abuse issues, or sensory impairments that affect testing cannot join.

Inclusion Criteria

I have been diagnosed with Parkinson's disease by a specialist.

I have had deep brain stimulation in both sides of my brain for over 3 months.

My condition has been diagnosed for over 4 years.

Exclusion Criteria

I have had brain surgery for Parkinson's disease.

I have a history of brain or nerve diseases, not including migraines.

You have significant mental health symptoms that meet specific criteria in a diagnostic manual, except for mild depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DBS Adjustment

Participants undergo personalized DBS setting adjustments based on pre- and post-implantation MRIs and perform cognitive tests

1-2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive processing and motor function after DBS adjustments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personalized DBS adjustments

Trial Overview The study is looking into how changing the location and frequency of stimulation in the subthalamic nucleus affects cognitive functions in Parkinson's patients with DBS implants. It aims to personalize DBS settings to improve non-motor symptoms.

How Is the Trial Designed?

Group I: Personalized DBS adjustments Experimental Treatment 1 Intervention

Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs

Who Is Running the Clinical Trial?

Darlene Floden

Lead Sponsor

Trials

1

Recruited

5+