real transcranial temporal interfe… for Parkinson's (NCT07625540)
Reduce movement and nonmotor symptoms
- Trial ID
- NCT07625540
- Official Title
- Study on the Efficacy and Safety of Subthalamic Nucleus (STN)-Targeted Transcranial Temporal Interference Stimulation (tTIS) for Motor and Non-Motor Symptoms in Parkinson's Disease (PD): A Randomized, Double-Blind, Controlled Exploratory Trial
- Goal
- Reduce movement and nonmotor symptoms
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study Type
- INTERVENTIONAL
- Enrollment
- 32 participants
- Conditions
- Parkinson's Disease (PD)
- Interventions
- real transcranial temporal interference stimulation, sham transcranial temporal interference stimulation
Summary For Families
The goal is to see whether a non-invasive deep brain stimulation method called transcranial temporal interference stimulation, or tTIS, can safely reduce both movement problems and non-movement symptoms in people with Parkinson's disease. The approach uses daily tTIS targeted to the subthalamic nucleus on both sides for five days, with 20 minutes per side using two high-frequency currents (2000 and 2130 hertz, giving a 130 hertz difference); each person gets a brain MRI and a computer model to guide electrode placement, while the control group follows the same steps but receives only brief fade-in and fade-out currents so participants stay blinded. People aged 50 to 85 with a clinical Parkinson's diagnosis and at least stage 2 on the Hoehn-Yahr scale who are on a stable Parkinson's medication plan can join, while those with prior invasive brain stimulation, certain implants or MRI problems, recent brain stimulation treatments, epilepsy, pregnancy, or major cognitive or psychiatric issues are excluded.
Locations
- Shanghai General Hospital, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying real transcranial temporal interference stimulation. The goal is to see whether a non-invasive deep brain stimulation method called transcranial temporal interference stimulation, or tTIS, can safely reduce both movement problems and non-movement symptoms in people with Parkinson's disease. The approach uses daily tTIS targeted to the subthalamic nucleus on both sides for five days, with 20 minutes per side using two high-frequency currents (2000 and 2130 hertz, giving a 130 hertz difference); each person gets a brain MRI and a computer model to guide electrode placement, while the control group follows the same steps but receives only brief fade-in and fade-out currents so participants stay blinded. People aged 50 to 85 with a clinical Parkinson's diagnosis and at least stage 2 on the Hoehn-Yahr scale who are on a stable Parkinson's medication plan can join, while those with prior invasive brain stimulation, certain implants or MRI problems, recent brain stimulation treatments, epilepsy, pregnancy, or major cognitive or psychiatric issues are excluded.
- Who can participate?
- Participants must be between 50 Years and 85 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 10 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 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 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?
- The tTIS intervention period is 5 days, with follow-up assessments immediately after the intervention, 10 days post-intervention, and 30 days post-intervention.
- 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.