Deep Brain Stimulation for Freezing of Gait in Parkinson's Disease

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Medical University of South Carolina

Disqualifiers: Gait impairment, MRI contraindications, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how Deep Brain Stimulation (DBS) affects people with Parkinson's Disease who experience Freezing of Gait (FOG), a condition where walking suddenly stops. Researchers will conduct MRI scans and various tests before and after DBS to monitor changes in walking and other symptoms over a year. Participants must have Parkinson's Disease with episodes of freezing while walking and plan to undergo DBS surgery.

As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective DBS treatment can benefit more patients.

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 is the safety track record for Deep Brain Stimulation (DBS)?

A previous study found Deep Brain Stimulation (DBS) to be safe and well-tolerated. Researchers reported no serious side effects, indicating no major health problems linked to the treatment. The FDA has approved DBS, and it has about 25 years of safety data supporting its use. This extensive testing and application in many patients with Parkinson's Disease demonstrate its reliability. Overall, DBS shows promise in alleviating symptoms like freezing of gait (FOG) while maintaining a strong safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it focuses on understanding how Deep Brain Stimulation (DBS) affects Parkinson's Disease (PD) patients experiencing freezing of gait (FOG). Unlike typical treatments for PD, which often include medications like Levodopa or physical therapy to manage symptoms, DBS involves implanting a device that sends electrical impulses to specific parts of the brain. This trial aims to identify imaging biomarkers that can predict how well a patient with FOG might respond to DBS. By uncovering these biomarkers, researchers hope to personalize treatment plans, potentially enhancing the effectiveness of DBS for those struggling with this challenging symptom.

What is the effectiveness track record for Deep Brain Stimulation in treating Parkinson's Disease with Freezing of Gait?

Research has shown that Deep Brain Stimulation (DBS), which participants in this trial will undergo, can help with freezing of gait (FOG) in people with Parkinson's disease. One study found that stimulating a specific part of the brain, the subthalamic nucleus, reduced FOG symptoms. However, DBS might not address balance problems in Parkinson's patients. Another study suggested that altering the frequency of the stimulation improved results for FOG. Overall, DBS is considered a useful treatment for managing some symptoms of Parkinson's disease, including FOG. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been chosen for STN-DBS surgery at the MUSC DBS Conference.

I am over 40 years old.

I have been diagnosed with Parkinson's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo MRI scan, behavioral assessment related to walking, cognitive evaluation, and assessment of other Parkinson's disease symptoms

4 weeks

3 visits (in-person)

Post-operative Assessment

Participants repeat assessments including behavioral measures of FOG response and imaging measures of neural response to stimulation

12 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation (DBS)

How Is the Trial Designed?

Group I: PD Patients with FOG undergoing DBS Active Control 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30641837/

Long-term effect of subthalamic nucleus deep brain ... Subthalamic nucleus deep brain stimulation (STN DBS) is effective against freezing of gait (FOG) in Parkinson's disease (PD); however, whether this effect ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1878875024005837

Effectiveness of Deep Brain Stimulation in Improving ... Current research suggests that DBS results in no significant improvement in balance dysfunction for people with PD.

3. neurology.org neurology.org/doi/10.1212/01.wnl.0000303972.16279.46

STN-DBS frequency effects on freezing of gait in advanced ... Our results prompt consideration of a new strategy for two-stage subthalamic nucleus deep brain stimulation (STN-DBS) frequency optimization.

4. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2021.651168/full

Safety and Tolerability of Burst-Cycling Deep Brain ... Background: Freezing of gait (FOG) is a common symptom in Parkinson's disease (PD) and can be difficult to treat with dopaminergic medications ...

5. academic.oup.com academic.oup.com/braincomms/article/5/5/fcad238/7259839

Optimal subthalamic stimulation sites and related networks for ... Although high-frequency subthalamic deep brain stimulation is an effective treatment for Parkinson's disease, post-operative freezing of gait ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5821065/

Deep Brain Stimulation to Alleviate Freezing of Gait and ... Deep brain stimulation (DBS) proves effective for FOG in PD patients. Cognitive impairment plays a role in the formation of FOG.

7. news.med.miami.edu news.med.miami.edu/deep-brain-stimulation-gait/

Deep Brain Stimulation for “Freezing of Gait” in Parkinson's ... While standard deep brain stimulation has about 25 years of safety and effectiveness data and is FDA-approved, there is still much to learn ...

8. scholars.duke.edu scholars.duke.edu/publication/1585309

Safety and Tolerability of Burst-Cycling Deep Brain ... Results: There were no serious adverse events with BCDBS. It was feasible and straightforward to program BCDBS in the clinic setting. The benefit was comparable ...