Predict brain stimulation easing freezing
- Trial ID
- NCT06951906
- Official Title
- Imaging Biomarkers of Freezing of Gait Response to Deep Brain Stimulation
- Goal
- Predict brain stimulation easing freezing
- 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 identify brain imaging markers that predict whether subthalamic nucleus deep brain stimulation will help with freezing of gait in people with Parkinson's. The team uses fMRI to map brain activity linked to freezing and to the response to DBS, while the DBS itself delivers continuous electrical pulses to the subthalamic nucleus to modulate abnormal motor circuits, often improving tremor and motor fluctuations and sometimes allowing lower levodopa doses, though effects on freezing can vary. The study is for adults over 40 with Parkinson's by UK Brain Bank criteria who have documented freezing of gait and have been clinically selected for STN-DBS at MUSC; people with non-PD gait problems, inability to complete OFF-state gait tests, MRI contraindications, or non-3T MRI compatible DBS devices are excluded.
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 identify brain imaging markers that predict whether subthalamic nucleus deep brain stimulation will help with freezing of gait in people with Parkinson's. The team uses fMRI to map brain activity linked to freezing and to the response to DBS, while the DBS itself delivers continuous electrical pulses to the subthalamic nucleus to modulate abnormal motor circuits, often improving tremor and motor fluctuations and sometimes allowing lower levodopa doses, though effects on freezing can vary. The study is for adults over 40 with Parkinson's by UK Brain Bank criteria who have documented freezing of gait and have been clinically selected for STN-DBS at MUSC; people with non-PD gait problems, inability to complete OFF-state gait tests, MRI contraindications, or non-3T MRI compatible DBS devices are excluded.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 5 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.