Determine side that reduces freezing
- Trial ID
- NCT06994728
- Official Title
- Characterization of Subthalamic Nucleus Deep Brain Stimulation Laterality on Visuospatial Attention and Correlation to Freezing of Gait in Parkinson's Disease
- Goal
- Determine side that reduces freezing
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Medical University of South Carolina
- Study Type
- INTERVENTIONAL
- Enrollment
- 12 participants
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic, Visuospatial/Perceptual Abilities
- Interventions
- Left STN-DBS on, right STN-DBS off first, Right STN-DBS on, left STN-DBS off first
Summary For Families
The team wants to know whether turning on deep brain stimulation on the left versus the right subthalamic nucleus changes visuospatial attention, and whether those side-specific effects are linked to freezing of gait in Parkinson's. To find out, they will temporarily switch bilateral STN-DBS so only one side is on at a time and test attention and gait; STN-DBS delivers targeted electrical pulses to the subthalamic nucleus to modulate motor and related cognitive circuits, which helps movement but can sometimes alter attention depending on the side stimulated. Adults 18 and older who already have bilateral STN-DBS and experience freezing of gait can join, while people with dementia, uncorrected vision or hearing problems, or who are pregnant are excluded.
Locations
- Medical University of South Carolina, Charleston, South Carolina, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Left STN-DBS on, right STN-DBS off first. The team wants to know whether turning on deep brain stimulation on the left versus the right subthalamic nucleus changes visuospatial attention, and whether those side-specific effects are linked to freezing of gait in Parkinson's. To find out, they will temporarily switch bilateral STN-DBS so only one side is on at a time and test attention and gait; STN-DBS delivers targeted electrical pulses to the subthalamic nucleus to modulate motor and related cognitive circuits, which helps movement but can sometimes alter attention depending on the side stimulated. Adults 18 and older who already have bilateral STN-DBS and experience freezing of gait can join, while people with dementia, uncorrected vision or hearing problems, or who are pregnant are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- 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 1 year and 2 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.