Intraoperative Behavioral Testing for Parkinson's (NCT05482126)
Improve movement by filtering sensations
- Trial ID
- NCT05482126
- Official Title
- Sensory Filtering in the Human Basal Ganglia as a Mechanism of Parkinson's Disease
- Goal
- Improve movement by filtering sensations
- 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 find out how a deep brain area called the basal ganglia helps filter out unimportant sensory signals during movement, and how that filtering relates to symptom severity in Parkinson's disease and similar movement disorders. During routine awake deep brain stimulation surgery, researchers will add a temporary strip electrode on the brain surface, give short sensory prompts like lights, vibrations, small electrical pulses, or limb position cues while people do simple movement tasks, and record brain signals plus muscle activity, motion sensors, scalp recordings, or speech. The team will compare the effects of the usual high-frequency electrical pulses used in deep brain stimulation with other patterns of stimulation, and will also look at how dopaminergic medicines change the recorded signals and task performance. Adults over 18 are being enrolled, either people with advanced Parkinson's who have chosen deep brain stimulation surgery aimed at the subthalamic nucleus, or healthy adults without neurological disease; Parkinson's patients must have a normal preoperative magnetic resonance imaging scan, no prior deep brain stimulation, no dementia, and be able to withhold Parkinson's medicines for at least 12 hours.
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 find out how a deep brain area called the basal ganglia helps filter out unimportant sensory signals during movement, and how that filtering relates to symptom severity in Parkinson's disease and similar movement disorders. During routine awake deep brain stimulation surgery, researchers will add a temporary strip electrode on the brain surface, give short sensory prompts like lights, vibrations, small electrical pulses, or limb position cues while people do simple movement tasks, and record brain signals plus muscle activity, motion sensors, scalp recordings, or speech. The team will compare the effects of the usual high-frequency electrical pulses used in deep brain stimulation with other patterns of stimulation, and will also look at how dopaminergic medicines change the recorded signals and task performance. Adults over 18 are being enrolled, either people with advanced Parkinson's who have chosen deep brain stimulation surgery aimed at the subthalamic nucleus, or healthy adults without neurological disease; Parkinson's patients must have a normal preoperative magnetic resonance imaging scan, no prior deep brain stimulation, no dementia, and be able to withhold Parkinson's medicines for at least 12 hours.
- 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?
- 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 4 years and 2 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); Brain wave recording (EEG) (non-invasive). Confirm the full schedule with the study coordinator.