DBS on/off for Parkinson's (NCT06485986)
Reduce impulsivity through brain stimulation
- Trial ID
- NCT06485986
- Official Title
- Frontosubthalamic Network Dynamics and Their Modulation During Impulse Control and Decision Making in Parkinson's Disease
- Goal
- Reduce impulsivity through brain stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Oxford
- Study Type
- INTERVENTIONAL
- Enrollment
- 20 participants
- Conditions
- Parkinson Disease, Impulse Control Disorder
- Interventions
- DBS on/off
Summary For Families
The goal is to find out why some people become more impulsive after deep brain stimulation of a brain area called the subthalamic nucleus, by mapping how stimulation changes brain networks and testing whether different stimulation settings can reduce that impulsivity. Participants will do decision-making tasks while their stimulation is switched on and off, and researchers will record brain activity with magnetoencephalography, a non-invasive scan that measures brain signals in real time. The study is for adults 18 and older who have Parkinson's disease with implanted subthalamic nucleus electrodes and who take dopamine replacement medication; people with or without diagnosed impulse control problems can join, but they must be able to sit in the scanner, delay their morning dopamine dose for up to four hours, and not have other implants or neurological conditions that would interfere with the recordings.
Locations
- John Radcliffe Hospital, Oxford, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DBS on/off. The goal is to find out why some people become more impulsive after deep brain stimulation of a brain area called the subthalamic nucleus, by mapping how stimulation changes brain networks and testing whether different stimulation settings can reduce that impulsivity. Participants will do decision-making tasks while their stimulation is switched on and off, and researchers will record brain activity with magnetoencephalography, a non-invasive scan that measures brain signals in real time. The study is for adults 18 and older who have Parkinson's disease with implanted subthalamic nucleus electrodes and who take dopamine replacement medication; people with or without diagnosed impulse control problems can join, but they must be able to sit in the scanner, delay their morning dopamine dose for up to four hours, and not have other implants or neurological conditions that would interfere with the recordings.
- 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 2 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.