Deep Brain Stimulation for Parkinson's Disease
(DBS visuomotor Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how deep brain stimulation, a treatment using electrical signals to aid brain function, can improve eye movement issues in people with Parkinson's disease. The focus is on helping patients align their eyes to see objects clearly at various distances. The goal is to determine the best way to use this treatment to enhance vision while managing other Parkinson's symptoms. People with Parkinson's who already have deep brain stimulation and stable treatment plans might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires participants to have a stable medication regimen, so you will not need to stop taking your current Parkinson's medications.
What prior data suggests that Deep Brain Stimulation is safe for treating vergence impairment in Parkinson's disease?
Research shows that Deep Brain Stimulation (DBS) has been safely used for various conditions, such as Parkinson's disease. Studies have found it effective, though it carries some risks. Some patients experience minor issues, like skin irritation or sores from the electrodes. More serious problems, such as bleeding in the brain or infection, are less common but possible.
The FDA has approved DBS for several uses, indicating a certain level of safety. However, all medical treatments can have side effects. While many people tolerate DBS well, discussing potential risks with a healthcare provider is crucial.1234Why are researchers excited about this trial?
Researchers are excited about Deep Brain Stimulation (DBS) for Parkinson's disease because it offers a unique approach compared to existing treatments like medication and physical therapy. Unlike standard drugs that primarily manage symptoms by affecting dopamine levels, DBS targets specific brain areas directly to improve visuomotor function. This technique involves implanting a device that sends electrical impulses to the brain, potentially providing more precise symptom control and reducing the need for medication. This direct brain stimulation method may lead to better management of movement and coordination issues, which is a significant step forward for patients with Parkinson's disease.
What evidence suggests that Deep Brain Stimulation is effective for vergence impairment in Parkinson's disease?
Research has shown that deep brain stimulation (DBS) can greatly help people with Parkinson's disease. Studies have found that DBS in a specific brain area can improve movement and daily activities for up to five years. Although DBS does not stop the disease from progressing, it provides lasting relief from movement problems. In one study, many patients experienced significant to moderate improvements in their condition. Overall, evidence supports DBS as an effective way to manage Parkinson’s disease symptoms.56789
Who Is on the Research Team?
Aasef G. Shaikh, MD PhD
Principal Investigator
Louis Stokes VA Medical Center, Cleveland, OH
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Deep Brain Stimulation Treatment
Participants undergo deep brain stimulation to assess its effects on vergence and eye alignment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Deep Brain Stimulation
Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Stroke-related motor deficits (under investigation)
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Citations
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.
ufhealth.org
ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patientsUF-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 ...
Long-term outcomes following deep brain stimulation for ...
DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression in PD, it provides durable ...
Global improvement after deep brain stimulation in ...
Among 51 PD patients, CGI rated 21 as “very much improved,” 21 “much improved,” and 9 “minimally improved,” primarily based on MDS-UPDRS III reduction.
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.
6.
europe.medtronic.com
europe.medtronic.com/xd-en/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation/indications-safety-warnings.htmlDeep Brain Stimulation - Indications, Safety, and Warnings
The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per month over the three most ...
P960009/S478 Summary of Safety and Effectiveness (SSED)
Medtronic's Deep Brain Stimulator (DBS) System was approved for the following indications for use: • P960009 approved on July 31, 1997: Unilateral thalamic ...
The safety issues and hardware-related complications of ...
The immune rejection reactions seen in patients mainly manifested as skin irritation or ulceration stimulated by the DBS electrode, and/or an ...
Deep brain stimulation
Surgery risks · Misplacement of the wires with the electrodes, known as leads. · Bleeding in the brain. · Stroke. · Infection. · Trouble breathing.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.