Deep Brain Stimulation for Parkinson's Disease

Overseen By Nathan DeTurk, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Dementia, Brain lesions, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how deep brain stimulation (DBS) affects attention and visual thinking in people with Parkinson's disease, particularly those experiencing freezing of gait (FOG), a sudden inability to move. The study will test DBS by alternating its activation on different sides of the brain to determine its effect on FOG and attention. Participants must have Parkinson's, experience freezing of gait, and have undergone DBS surgery on both sides of the brain. As an unphased trial, this study provides a unique opportunity to enhance understanding of DBS's impact on cognitive functions in Parkinson's 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 prior data suggests that deep brain stimulation is safe for Parkinson's disease?

Research has shown that deep brain stimulation (DBS) is generally safe for people with Parkinson's disease and is well-tolerated over time. One study followed patients for five years and found that DBS not only helped with movement problems but also remained safe. Another study found that a frameless system for DBS was safe and well-tolerated by patients. Overall, DBS has been effectively used in certain Parkinson's patients, and evidence suggests it is a safe option for managing symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Parkinson's disease, which often involve medications like Levodopa that aim to replace dopamine, Deep Brain Stimulation (DBS) offers a different approach. Researchers are excited about DBS because it directly targets the brain's subthalamic nucleus (STN) with electrical impulses. This technique can help regulate brain activity more precisely and may lead to improvements in motor symptoms that medications alone can't achieve. Additionally, the trial explores the effects of turning DBS on and off on different sides of the brain, which could refine how we use this technology for better outcomes.

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

Research has shown that deep brain stimulation (DBS) in a specific brain area effectively treats Parkinson's disease. One study found that after five years, DBS greatly improved patients' movement and ability to perform daily tasks. Another study showed that DBS reduced discomfort and sensory issues related to Parkinson's after six months. Overall, DBS is a proven and safe way to help manage Parkinson's symptoms. In this trial, participants will receive STN-DBS with different configurations: one group will have the right STN-DBS on and left STN-DBS off first, while the other group will have the left STN-DBS on and right STN-DBS off first. Recent research suggests that stimulating the right side of the brain might help with freezing of gait (FOG), a common and difficult symptom of Parkinson's. ^{2 3 6 7 8}

Who Is on the Research Team?

Nathan DeTurk, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who experience gait impairment and visuospatial perception issues. It specifically targets those interested in how deep brain stimulation (DBS) might affect their condition, particularly freezing of gait.

Inclusion Criteria

I am over 18 years old.

Subjects with freezing of gait

I have had DBS surgery on both sides of my brain for Parkinson's.

Exclusion Criteria

Uncorrected visual or hearing impairments, as indicated by self-report

Individuals who are pregnant or expect to become pregnant during the course of the study

I have dementia or brain lesions affecting my thinking or walking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lateralized STN-DBS stimulation to assess its impact on visuospatial attention and freezing of gait

1-2 weeks

Multiple sessions for DBS adjustment and assessment

Assessment

Participants are evaluated using tasks such as timed up and go, Go-No-Go, and Flanker tasks to measure changes in attention and freezing of gait

1 hour per session

Several assessment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STN-DBS

Trial Overview The study tests the effects of activating right or left subthalamic nucleus (STN) DBS on attention and visuospatial function in Parkinson's patients. Researchers are exploring if stimulating one side can improve freezing of gait by alternating which side of the STN-DBS is turned on first.

How Is the Trial Designed?

Group I: Right STN-DBS on, left STN-DBS off first Active Control 1 Intervention

STN-DBS will be turned off sequentially for each side, in this group beginning with right STN-DBS on and left STN-DBS off. This will then be followed by the corollary.

Group II: Left STN-DBS on, right STN-DBS off first Active Control 1 Intervention

STN-DBS will be turned off sequentially for each side, in this group beginning with left STN-DBS on and right STN-DBS off. This will then be followed by the corollary.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12439180/

Five-Year Outcomes from Deep Brain Stimulation of the ... This cohort study evaluates 5-year outcomes and safety of subthalamic nucleus deep brain stimulation for the treatment of Parkinson disease.

2. parkinsonsnewstoday.com parkinsonsnewstoday.com/news/lasting-relief-parkinsons-motor-symptoms-found-dbs-us-study/

Lasting relief of Parkinson's motor symptoms found with DBS Deep brain stimulation, a surgical procedure known as DBS, provides relief of Parkinson's motor symptoms after five years, per a U.S. study.

3. nature.com nature.com/articles/s41531-024-00689-z

Efficacy of deep brain stimulation of the subthalamic ... Following six months, subthalamic (STN)-DBS reduced sensory complaints related to parkinsonism and bodily discomfort, increasing central beta-endorphin level.

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000208760

Sustained Benefits of Deep Brain Stimulation of the ... This 5-year data demonstrates that STN-DBS provides significant and sustained improvements in motor function and activities of daily living.

5. sciencedirect.com sciencedirect.com/science/article/pii/S294966912300009X

Deep brain stimulation of the subthalamic nucleus in ... Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a proven effective and safe method for patients with Parkinson's disease (PD).

6. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2838886

Five-Year Outcomes from Deep Brain Stimulation of the ... This cohort study evaluates 5-year outcomes and safety of subthalamic nucleus deep brain stimulation for the treatment of Parkinson disease.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37700176/

Long-term safety and efficacy of frameless subthalamic ... Conclusions: Our data support the use of the frameless system for STN-DBS in PD patients, as a safe and well-tolerated technique, with long-term ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715922010108

PO061 / #228 LONG-TERM OUTCOME OF ... STN DBS is a safe and effective treatment in selective patients with PD. This study was based on the long-term follow-up of large-scale patients, and would ...