fMRI for Parkinson's (NCT06951906)
Reduce freezing episodes while walking
- Trial ID
- NCT06951906
- Official Title
- Imaging Biomarkers of Freezing of Gait Response to Deep Brain Stimulation
- Goal
- Reduce freezing episodes while walking
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- Medical University of South Carolina
- Study Type
- INTERVENTIONAL
- Enrollment
- 54 participants
- Conditions
- Freezing of Gait Symptoms in Parkinson's Disease, Deep Brain Stimulation
- Interventions
- fMRI
Summary For Families
The goal is to learn why and how freezing of gait in Parkinson's changes after deep brain stimulation of a brain area called the subthalamic nucleus, so treatment can be tailored to each person. Participants will have detailed brain scans, walking tests, thinking tests, and other symptom checks before surgery, then repeat the same assessments at several times after surgery over one year, for a total of seven visits. The team will study which brain connections and the health of those connections, plus where the stimulation lead is placed and how it is programmed, are linked with walking improvement. The study will enroll 54 people with Parkinson's who are over 40, have experienced freezing of gait, and have already been selected to have subthalamic nucleus deep brain stimulation; people with other non-Parkinson's gait problems, who cannot complete the walking tests without help, or who cannot have MRI are not eligible.
Locations
- Medical University of South Carolina, Charleston, South Carolina, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying fMRI. The goal is to learn why and how freezing of gait in Parkinson's changes after deep brain stimulation of a brain area called the subthalamic nucleus, so treatment can be tailored to each person. Participants will have detailed brain scans, walking tests, thinking tests, and other symptom checks before surgery, then repeat the same assessments at several times after surgery over one year, for a total of seven visits. The team will study which brain connections and the health of those connections, plus where the stimulation lead is placed and how it is programmed, are linked with walking improvement. The study will enroll 54 people with Parkinson's who are over 40, have experienced freezing of gait, and have already been selected to have subthalamic nucleus deep brain stimulation; people with other non-Parkinson's gait problems, who cannot complete the walking tests without help, or who cannot have MRI are not eligible.
- Who can participate?
- Participants must be at least 40 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 Phase 4 trial is estimated to last approximately 5 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- You will complete 7 in-person study visits over approximately 1 year.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.