Procedure/Surgery: Response Inhibi… for Parkinson's (NCT04735458)
Improve ability to stop actions
- Trial ID
- NCT04735458
- Official Title
- Investigating Inhibitory Control Networks in Parkinson's Disease
- Goal
- Improve ability to stop actions
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Alabama at Birmingham
- Study Type
- INTERVENTIONAL
- Enrollment
- 140 participants
- Conditions
- Parkinson Disease
- Interventions
- Procedure/Surgery: Response Inhibition and Deep Brain Stimulation in Parkinson's disease
Summary For Families
The goal is to map and modulate the brain circuits that let you stop or control movements, so researchers can better understand why people with Parkinson's have trouble with response inhibition and impulsive actions. The approach uses deep brain stimulation, implanting electrodes to deliver targeted electrical pulses while participants do behavioral stopping tasks and have brain signals recorded, so the team can see how DBS changes the neural activity that halts actions; DBS alters abnormal circuit activity and can also change how symptoms respond to levodopa, sometimes allowing medication adjustments. The study is looking for adults 18 and older who are judged eligible for movement‑disorder surgery with Parkinson's disease, essential tremor, or another medically‑refractory movement disorder and who can give informed consent and participate in the protocol. People with prior stroke, brain hemorrhage, seizures, or who cannot complete study activities are excluded.
Locations
- University of Alabama at Birmingham, Birmingham, Alabama, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Procedure/Surgery: Response Inhibition and Deep Brain Stimulation in Parkinson's disease. The goal is to map and modulate the brain circuits that let you stop or control movements, so researchers can better understand why people with Parkinson's have trouble with response inhibition and impulsive actions. The approach uses deep brain stimulation, implanting electrodes to deliver targeted electrical pulses while participants do behavioral stopping tasks and have brain signals recorded, so the team can see how DBS changes the neural activity that halts actions; DBS alters abnormal circuit activity and can also change how symptoms respond to levodopa, sometimes allowing medication adjustments. The study is looking for adults 18 and older who are judged eligible for movement‑disorder surgery with Parkinson's disease, essential tremor, or another medically‑refractory movement disorder and who can give informed consent and participate in the protocol. People with prior stroke, brain hemorrhage, seizures, or who cannot complete study activities 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?
- 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 6 years.
- 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 trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive). Confirm the full schedule with the study coordinator.