Home-based Transcranial Temporal I… for Parkinson's (NCT07518290)
Can home stimulation improve movement
- Trial ID
- NCT07518290
- Official Title
- Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease: Protocol For a Double Blind Randomized Controlled Trial
- Goal
- Can home stimulation improve movement
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Shanghai University of Sport
- Study Type
- INTERVENTIONAL
- Enrollment
- 68 participants
- Conditions
- PARKINSON DISEASE (Disorder), Motor Symptoms
- Interventions
- Home-based Transcranial Temporal Interference Stimulation (HB-TIS)
Summary For Families
The study is testing whether doing temporal interference stimulation at home can improve Parkinson's movement problems, like slowed movement, stiffness, and trouble walking, and whether any benefits last after the treatment while also checking for side effects. Participants will use a home device that delivers temporal interference stimulation to the head once a day for four weeks under remote supervision; some people will get active stimulation and others a sham look-alike so researchers can compare results, and everyone will have clinic visits and online questionnaires to track changes. The trial is for adults 40 to 80 with mild-to-moderate Parkinson's (stages 1.5 to 3), who are on a stable Parkinson's medication plan and can walk unaided for at least two minutes; people with deep brain stimulators, certain metal implants or pacemakers, major memory problems, other serious brain conditions, or certain psychiatric illnesses are excluded.
Locations
- Shanghai University of Sport, Shanghai, Shanghai Municipality, China
- Shanghai University of Sport, Shanghai, Shanghai Municipality, 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 NCT07518290. It is the one about "Can home stimulation improve movement". 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?
- 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 Home-based Transcranial Temporal Interference Stimulation (HB-TIS). The study is testing whether doing temporal interference stimulation at home can improve Parkinson's movement problems, like slowed movement, stiffness, and trouble walking, and whether any benefits last after the treatment while also checking for side effects. Participants will use a home device that delivers temporal interference stimulation to the head once a day for four weeks under remote supervision; some people will get active stimulation and others a sham look-alike so researchers can compare results, and everyone will have clinic visits and online questionnaires to track changes. The trial is for adults 40 to 80 with mild-to-moderate Parkinson's (stages 1.5 to 3), who are on a stable Parkinson's medication plan and can walk unaided for at least two minutes; people with deep brain stimulators, certain metal implants or pacemakers, major memory problems, other serious brain conditions, or certain psychiatric illnesses are excluded.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 1 year and 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.