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
- Registry Record Last Updated
- 2026-07-21 (this month)
- Estimated Commitment
- Lower commitment estimated from the protocol (based on: placebo or control group). This reflects time and procedures only — confirm details with the study coordinator.
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.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Hoehn and Yahr stage 1.5 to 3
- Deep brain stimulation: Cannot join after DBS surgery (deep brain stimulation) (criteria text: "history of deep brain stimulation (dbs) surgery")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people up to age 85.
- This trial does not enroll people who have had (or are scheduled for) DBS surgery.
- This trial requires Hoehn and Yahr stage 1.5 to 3.
Locations
- Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07568067. It is the one about "Improve speech with brain stimulation". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: Participants will receive a consecutive 5-day treatment course and will have fMRI scans at two fixed time points (baseline before treatment and after completion). Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 4 groups, and 2 are sham (a pretend version of the procedure) groups. Whether you are placed in the sham group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the sham group would be.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
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?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; 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 4 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. Whether you are placed in the sham group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the sham group would be.
- How many visits does this trial involve?
- Participants will receive a consecutive 5-day treatment course and will have fMRI scans at two fixed time points (baseline before treatment and after completion).
- 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.