Response Inhibition and Deep Brain… for Parkinson's (NCT04061135)
Brain stimulation improves stopping movements
- Trial ID
- NCT04061135
- Official Title
- Neurophysiological, Behavioral, and Cognitive Networks in Movement Disorders
- Goal
- Brain stimulation improves stopping movements
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Alabama at Birmingham
- Study Type
- INTERVENTIONAL
- Enrollment
- 90 participants
- Conditions
- Movement Disorders
- Interventions
- Response Inhibition and Deep Brain Stimulation in Parkinson's disease
Summary For Families
They want to map how deep brain stimulation changes the brain networks that control stopping or changing movements, like response inhibition, and how those changes relate to behavior and thinking in Parkinson's disease and essential tremor. People having DBS surgery will perform response inhibition tasks while researchers record brain activity and test how the implanted device's electrical pulses alter those signals and task performance; DBS delivers targeted electrical stimulation to deep brain regions to reduce motor symptoms and can modulate cognitive control circuits. Adults 18 and older with Parkinson's disease or essential tremor who are judged suitable for DBS surgery and can give informed consent and take part in the testing are eligible, while people who are not surgical candidates, cannot consent, are pregnant, or have not tried conservative medical management are excluded.
Locations
- University of Alabama at Birmingham, Birmingham, Alabama, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Response Inhibition and Deep Brain Stimulation in Parkinson's disease. They want to map how deep brain stimulation changes the brain networks that control stopping or changing movements, like response inhibition, and how those changes relate to behavior and thinking in Parkinson's disease and essential tremor. People having DBS surgery will perform response inhibition tasks while researchers record brain activity and test how the implanted device's electrical pulses alter those signals and task performance; DBS delivers targeted electrical stimulation to deep brain regions to reduce motor symptoms and can modulate cognitive control circuits. Adults 18 and older with Parkinson's disease or essential tremor who are judged suitable for DBS surgery and can give informed consent and take part in the testing are eligible, while people who are not surgical candidates, cannot consent, are pregnant, or have not tried conservative medical management 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 8 years and 7 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 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.