Deep Brain Stimulation for Parkinson's Disease

Overseen By Sarah Bedell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Pregnancy, Claustrophobia, MRI contraindications, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 hours

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called deep brain stimulation (DBS) for people with Parkinson's disease who experience movement and balance issues that do not improve with regular medication. The goal is to improve symptoms like freezing of gait (a sudden inability to move) by targeting specific brain areas more effectively. The research aims to refine DBS use, enhancing its benefits and reducing negative effects. Suitable participants have Parkinson's, already possess a compatible DBS device, and speak English. As an unphased trial, this study offers participants the chance to contribute to advancing DBS treatment techniques for Parkinson's disease.

Do I need to stop my current medications for this trial?

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 this deep brain stimulation technique is safe for Parkinson's disease patients?

Research has shown that deep brain stimulation (DBS) is a proven treatment for Parkinson's disease. The FDA has approved it, indicating its general safety for treating Parkinson's. Studies have found that DBS can improve movement issues like tremors and stiffness. However, side effects can occur. Some individuals may experience speech difficulties, muscle spasms, or changes in eye movements after DBS.

While many patients tolerate DBS well, awareness of these potential side effects is important. The current study aims to enhance DBS by improving results and reducing these side effects. Those considering joining a trial should discuss potential risks with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about bipolar deep brain stimulation (DBS) for Parkinson's Disease because it offers a new way to manage symptoms. Unlike traditional DBS, which typically uses a constant electrical pulse, bipolar DBS precisely targets brain areas with alternating stimulation patterns. This method aims to reduce side effects and improve overall control of motor symptoms. By refining how electrical signals are delivered in the brain, researchers hope this approach will enhance the quality of life for patients with Parkinson's Disease.

What evidence suggests that this deep brain stimulation is effective for Parkinson's disease?

Research has shown that deep brain stimulation (DBS) effectively treats movement problems in people with Parkinson's disease. Studies have found that DBS, particularly when targeting the subthalamic nucleus (STN), can improve movement abilities by up to 71%. In this trial, participants will receive bipolar DBS, which uses both positive and negative electrodes. This approach may reduce side effects more effectively than other types while still controlling tremors. DBS may help manage symptoms that do not respond well to standard dopamine treatments. Overall, DBS offers a promising option for improving movement and reducing falls in people with Parkinson's disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Noam Harel, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who experience postural instability and gait disturbances that don't improve with standard medications like levodopa. The study seeks to understand how deep brain stimulation (DBS) can better control these symptoms.

Inclusion Criteria

English speaking

I have a Medtronic Percept DBS device for Parkinson's.

I am 21 years old or older.

Exclusion Criteria

Implanted with a DBS device that is not MR compatible

Pregnant

Extreme claustrophobia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo functional MRI scanning with DBS cycling between ON and OFF stimulation to measure BOLD signal changes

8 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the MRI scanning procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bipolar DBS stimulation

Trial Overview The trial is testing the effects of bipolar DBS stimulation on patients with Parkinson's Disease, specifically targeting symptoms such as freezing of gait that are resistant to medication. It aims to refine techniques for stimulating neural networks to enhance patient outcomes.

How Is the Trial Designed?

Group I: Study group Experimental Treatment 1 Intervention

2 Study Procedures: Patients who have been already implanted with a MRI compatible DBS device (Medtronic Percept / Percept RC™)

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32040883/

Bipolar Directional Deep Brain Stimulation in Essential and ... Bipolar DBS with directional anodes evoked side-effect less frequently than bipolar and monopolar directional stimulation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6440024/

An update on best practice of deep brain stimulation in ... Initial data on STN DBS showed an impressive improvement of the Unified Parkinson's Disease Rating Scale motor subscore (UPDRS-III), by 49–71%, and a marked ...

3. nature.com nature.com/articles/s41467-025-59113-6

Deep brain stimulation alleviates Parkinsonian motor ... High-frequency deep brain stimulation (DBS) at subthalamic nucleus (STN) is an effective therapy for Parkinson's disease (PD), ...

4. jneurosci.org jneurosci.org/content/43/45/7575

Advances in Deep Brain Stimulation: From Mechanisms to ... A 2016 study validated the acute benefits of CR DBS and a carryover effect of up to 2 weeks on a wider range of parkinsonian symptoms, including ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1094715921021577

Bipolar Directional Deep Brain Stimulation in Essential and ... Our hypothesis was that bipolar directional stimulation augments side-effect thresholds more than monopolar directional DBS, with equivalent tremor suppression.

6. ufhealth.org ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patients

UF-led study shows deep brain stimulation benefits for ... “DBS used to be seen as a last resort, but we now know it provides the most sustained benefit when offered in the moderate stages of Parkinson's ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1094715921064230

Directional Deep Brain Stimulation for Parkinson's Disease Potential side effects of chronic STN stimulation can include speech impairment, reduced verbal fluency, involuntary eye movement, muscle contraction, postural ...