Temporal Interference Stimulation for Parkinson's (NCT07568067)
Improve speech with brain stimulation
- Trial ID
- NCT07568067
- Official Title
- A Single-Center, Double-Blind Randomized Controlled Trial of Accelerated Temporal Interference Stimulation Applied to Bilateral Subthalamic Nucleus for Improving Motor and Vocal Functions in Patients With Parkinson's Disease Or Secondary Parkinson's Syndrome
- Goal
- Improve speech with brain stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Ke Dong, MD
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease, Parkinson Disease, Secondary
- Interventions
- Temporal Interference Stimulation, Temporal Interference Stimulation
Summary For Families
Researchers are testing whether a short, intensive course of temporal interference brain stimulation can improve movement and speaking in people with Parkinson's disease or secondary Parkinson's syndrome. The treatment delivers accelerated temporal interference stimulation to both sides of a deep brain area involved in movement, called the subthalamic nucleus, over five consecutive days while magnetic resonance brain scans look for changes; half the participants will wear identical equipment but receive a sham version that looks the same and has no active effect. The trial is looking for adults with a confirmed diagnosis at an early-to-mid stage (Hoehn-Yahr 1.5 to 3) who can walk independently, have no cognitive impairment, can undergo magnetic resonance scanning, have not had deep brain stimulation surgery, and are not older than 80 years.
Locations
- Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Temporal Interference Stimulation. Researchers are testing whether a short, intensive course of temporal interference brain stimulation can improve movement and speaking in people with Parkinson's disease or secondary Parkinson's syndrome. The treatment delivers accelerated temporal interference stimulation to both sides of a deep brain area involved in movement, called the subthalamic nucleus, over five consecutive days while magnetic resonance brain scans look for changes; half the participants will wear identical equipment but receive a sham version that looks the same and has no active effect. The trial is looking for adults with a confirmed diagnosis at an early-to-mid stage (Hoehn-Yahr 1.5 to 3) who can walk independently, have no cognitive impairment, can undergo magnetic resonance scanning, have not had deep brain stimulation surgery, and are not older than 80 years.
- Who can participate?
- Participants must be 85 Years or younger.
- 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 8 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 4 groups, and 2 are sham (a pretend version of the procedure) groups. Because assignment is random, you have about a 2 in 4 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- You will receive treatment twice daily for a consecutive 5-day course, with each session lasting 40 minutes and at least 1 hour between sessions.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive). Confirm the full schedule with the study coordinator.