Parkinson's Trial NCT05400499
Brain stimulation improves eye alignment
- Trial ID
- NCT05400499
- Official Title
- Deep Brain Stimulation for Visuomotor Function in Parkinsons Disease
- Goal
- Brain stimulation improves eye alignment
- Status
- RECRUITING
- Sponsor
- VA Office of Research and Development
- Study Type
- OBSERVATIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson's Disease
Summary For Families
Researchers want to find where deep brain stimulation in the subthalamic region can best help people with Parkinson's who have trouble aligning and refocusing their two eyes on objects at different depths, a problem that can cause double vision and poor depth perception, while still keeping the usual benefits for tremor, stiffness, and slowed movement. They will use each person’s brain scans and computer models of their implanted stimulation together with high-resolution eye tracking and eye exam equipment to see how different stimulation locations and settings change eye alignment and refocusing. The study is looking for people with Parkinson's who already have deep brain stimulation on both sides of the subthalamic region, have pre-operative MRI and can get post-operative MRI or CT scans, are at stage 2 to 4 when off medication, and have stable Parkinson's medications and stimulation settings; people with dementia, untreated major depression or anxiety, prior Parkinson's surgery other than deep brain stimulation, or signs of atypical parkinsonism are not eligible.
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. Researchers want to find where deep brain stimulation in the subthalamic region can best help people with Parkinson's who have trouble aligning and refocusing their two eyes on objects at different depths, a problem that can cause double vision and poor depth perception, while still keeping the usual benefits for tremor, stiffness, and slowed movement. They will use each person’s brain scans and computer models of their implanted stimulation together with high-resolution eye tracking and eye exam equipment to see how different stimulation locations and settings change eye alignment and refocusing. The study is looking for people with Parkinson's who already have deep brain stimulation on both sides of the subthalamic region, have pre-operative MRI and can get post-operative MRI or CT scans, are at stage 2 to 4 when off medication, and have stable Parkinson's medications and stimulation settings; people with dementia, untreated major depression or anxiety, prior Parkinson's surgery other than deep brain stimulation, or signs of atypical parkinsonism are not eligible.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 9 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.