Parkinson's Trial NCT06857851
Improve eye alignment and refocusing
- Trial ID
- NCT06857851
- Official Title
- Optimizing Deep Brain Stimulation to Improve Visuomotor Function in Parkinson's Disease
- Goal
- Improve eye alignment and refocusing
- Status
- RECRUITING
- Sponsor
- VA Office of Research and Development
- Study Type
- OBSERVATIONAL
- Enrollment
- 80 participants
- Conditions
- Parkinson's Disease
Summary For Families
The investigators want to find which locations and settings of deep brain stimulation can best improve problems with aligning the two eyes and refocusing between near and far objects, which often cause double vision and poor depth perception in people with Parkinson's, while keeping the treatment's benefits for tremor, stiffness, and slowed movement. To do that, they will use high-resolution eye-tracking to measure small changes in eye alignment and refocusing, and combine those measurements with each person’s brain scans and patient-specific computer models of stimulation to map where and how stimulation helps vision. The study is looking for people with Parkinson's who already have deep brain stimulation electrodes on both sides of the subthalamic area, can provide pre- and post-op scans, are at moderate disease stages when off medication, and have stable medications and stimulation settings; people with dementia, untreated depression or anxiety, prior other Parkinson's surgery, or signs of atypical parkinsonism are excluded.
Locations
- Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The investigators want to find which locations and settings of deep brain stimulation can best improve problems with aligning the two eyes and refocusing between near and far objects, which often cause double vision and poor depth perception in people with Parkinson's, while keeping the treatment's benefits for tremor, stiffness, and slowed movement. To do that, they will use high-resolution eye-tracking to measure small changes in eye alignment and refocusing, and combine those measurements with each person’s brain scans and patient-specific computer models of stimulation to map where and how stimulation helps vision. The study is looking for people with Parkinson's who already have deep brain stimulation electrodes on both sides of the subthalamic area, can provide pre- and post-op scans, are at moderate disease stages when off medication, and have stable medications and stimulation settings; people with dementia, untreated depression or anxiety, prior other Parkinson's surgery, or signs of atypical parkinsonism are excluded.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 8 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.