Improve movement via sensory filtering
- Trial ID
- NCT05482126
- Official Title
- Sensory Filtering in the Human Basal Ganglia as a Mechanism of Parkinson's Disease
- Goal
- Improve movement via sensory filtering
- Status
- RECRUITING
- Sponsor
- University of Alabama at Birmingham
- Study Type
- OBSERVATIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease
- Interventions
- Intraoperative Behavioral Testing, Behavioral Testing
Summary For Families
They want to know whether the basal ganglia normally filters out irrelevant sensory signals, and if a failure of that filtering helps cause the movement and response problems seen in Parkinson's. During routine surgery to place deep brain stimulation electrodes in the subthalamic nucleus, researchers will run behavioral tests and record brain activity directly from the basal ganglia to see how neurons register or suppress sensory cues, and PD participants will be asked to withhold dopaminergic medications for at least 12 hours so recordings reflect the unmedicated state. Adults 18 and older are eligible, specifically people with advanced, idiopathic PD who have chosen STN DBS, have essentially normal pre-op brain imaging and no dementia or prior DBS, plus healthy adult controls with no neurologic disease.
Locations
- The University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Intraoperative Behavioral Testing. They want to know whether the basal ganglia normally filters out irrelevant sensory signals, and if a failure of that filtering helps cause the movement and response problems seen in Parkinson's. During routine surgery to place deep brain stimulation electrodes in the subthalamic nucleus, researchers will run behavioral tests and record brain activity directly from the basal ganglia to see how neurons register or suppress sensory cues, and PD participants will be asked to withhold dopaminergic medications for at least 12 hours so recordings reflect the unmedicated state. Adults 18 and older are eligible, specifically people with advanced, idiopathic PD who have chosen STN DBS, have essentially normal pre-op brain imaging and no dementia or prior DBS, plus healthy adult controls with no neurologic disease.
- Who can participate?
- Participants must be between 18 Years and 89 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 4 years 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.