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?
- 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 6 years.
- 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.