Temporal Interference Stimulation for Parkinson's (NCT07721688)
Testing stimulation for movement voice
- Trial ID
- NCT07721688
- Official Title
- A Single-Center, Double-Blind Randomized Controlled Trial of Different Frequency Temporal Interference Stimulation Applied to Bilateral Subthalamic Nucleus for Improving Motor and Vocal Functions in Patients With Parkinson's Disease.
- Goal
- Testing stimulation for movement voice
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Ke Dong, MD
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- Temporal Interference Stimulation, Temporal Interference Stimulation
Summary For Families
The study is testing whether accelerated temporal interference stimulation can improve movement and speech problems in people with Parkinson's disease. It delivers targeted electrical stimulation to a small deep brain area called the subthalamic nuclei, with the side opposite the worse symptoms getting 130 hertz and the other side getting 60 hertz, given as a continuous five-day course and compared with a matching sham procedure. Researchers will use functional magnetic resonance imaging (fMRI) before and after the treatment to look for measurable changes in brain activity. The trial is looking for people with Parkinson's at mid stages of the disease (Hoehn and Yahr 1.5 to 3.0), who can walk independently, are on a stable levodopa-based medication plan for at least four weeks, have no major cognitive or psychiatric problems, have no implants or other reasons they cannot have MRI, and can give written consent.
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 surgery")
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 NCT07721688. It is the one about "Testing stimulation for movement voice". 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: There are two assessment visits (baseline and follow-up) and the intervention is administered as a consecutive 5-day fixed course. 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 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.
- 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. The study is testing whether accelerated temporal interference stimulation can improve movement and speech problems in people with Parkinson's disease. It delivers targeted electrical stimulation to a small deep brain area called the subthalamic nuclei, with the side opposite the worse symptoms getting 130 hertz and the other side getting 60 hertz, given as a continuous five-day course and compared with a matching sham procedure. Researchers will use functional magnetic resonance imaging (fMRI) before and after the treatment to look for measurable changes in brain activity. The trial is looking for people with Parkinson's at mid stages of the disease (Hoehn and Yahr 1.5 to 3.0), who can walk independently, are on a stable levodopa-based medication plan for at least four weeks, have no major cognitive or psychiatric problems, have no implants or other reasons they cannot have MRI, and can give written consent.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- 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 5 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?
- There are two assessment visits (baseline and follow-up) and the intervention is administered as a consecutive 5-day fixed course.
- 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.