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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how changes in the location and frequency of Deep Brain Stimulation (DBS) affect thinking and memory in people with Parkinson's disease. Participants will receive personalized DBS adjustments to determine if these changes can improve cognitive functions. It is suitable for individuals who have had Parkinson's for at least four years and have been treated with DBS for at least three months. As an unphased trial, this study allows participants to contribute to innovative research that could enhance DBS treatment for cognitive improvements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these DBS adjustments are safe for Parkinson's patients?

Research has shown that adjusting deep brain stimulation (DBS) settings for each person is generally safe for individuals with Parkinson’s disease. Studies have found that adaptive DBS, which automatically adjusts settings based on the body's needs, is both safe and effective over time. Participants in these studies reported an improved quality of life, and those with stable symptoms before the therapy found it beneficial. No major safety issues were reported in these studies, indicating that personalized DBS adjustments are a safe way to manage Parkinson’s symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about personalized DBS adjustments for Parkinson's disease because they offer a tailored approach to managing symptoms. Unlike traditional deep brain stimulation (DBS) that uses a one-size-fits-all setting, this method adjusts the stimulation based on individual MRI scans taken before and after DBS implantation. This customization aims to optimize the benefits while minimizing side effects, potentially leading to improved quality of life for patients. By honing in on the unique brain structure of each patient, personalized DBS has the potential to enhance treatment effectiveness and provide a more precise intervention compared to standard DBS settings.

What evidence suggests that personalized DBS adjustments are effective for Parkinson's disease?

Research has shown that personalized deep brain stimulation (DBS), which participants in this trial will receive, can effectively treat Parkinson's disease. Adjusting DBS based on brain activity often leads to better control of movement problems and improvements in quality of life. One study found that personalized DBS improved symptoms more than the standard version. Another trial demonstrated that this type of DBS can adapt to changes in the brain, providing the right amount of stimulation when needed. This approach helps manage symptoms better for those who continue to experience issues despite regular treatment. ^{1 2 3 5 6}

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+

Citations

1. parkinson.org parkinson.org/blog/science-news/personalized-dbs

New Study Further Personalizes Deep Brain Stimulation A small clinical trial showed the effectiveness of a new kind of DBS that responds to brain activity to offer customized stimulation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10463549/

Personalized chronic adaptive deep brain stimulation ... A blinded, randomized trial demonstrated improved motor symptoms and quality of life compared to clinically optimized standard stimulation.

3. nature.com nature.com/articles/s41531-025-01124-7

Chronic adaptive deep brain stimulation for Parkinson's ... Our findings support adaptive DBS as a potential option for selected Parkinson's disease patients with persistent motor symptoms on continuous ...

4. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2839117

Long-Term Personalized Adaptive Deep Brain Stimulation ... This nonrandomized clinical trial evaluates the use of adaptive deep brain stimulation in Parkinson disease.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40982287/

Long-Term Personalized Adaptive Deep Brain Stimulation ... Importance: Adaptive deep brain stimulation (aDBS) automatically adjusts stimulation amplitude in response to changes in relevant neural ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12455485/

Long-Term Personalized Adaptive Deep Brain Stimulation ... Long-term aDBS provided tolerable, effective, and safe therapy in persons with Parkinson disease whose symptoms were previously stable while ...