--- title: Testing stimulation for movement voice nct_id: NCT07721688 phase: NA status: RECRUITING sponsor: Ke Dong, MD study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT07721688" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07721688" last_fetched: "2026-07-24T14:02:29.122Z" source: "Parkinson's Pathways (curated)" --- # Testing stimulation for movement voice **Goal (in five words):** Testing stimulation for movement voice **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. **Trial ID:** [NCT07721688](https://clinicaltrials.gov/study/NCT07721688) ## Key Facts - **Phase:** NA - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** Ke Dong, MD - **Target Enrollment:** 60 participants - **Start Date:** 2026-07-20 - **Completion Date:** 2026-12-31 - **Conditions:** Parkinson Disease (PD) - **Interventions:** Temporal Interference Stimulation, Temporal Interference Stimulation - **Intervention Types:** DEVICE ## 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. ## What This Actually Involves **Placebo** _(From the protocol)_: 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. **Visits** _(From the protocol)_: There are two assessment visits (baseline and follow-up) and the intervention is administered as a consecutive 5-day fixed course. > "Receive continuous targeted intervention of either formal TIS or matched sham stimulation on bilateral subthalamic nuclei, with consecutive 5-day fixed-course administration in strict accordance with trial operating specifications. Complete unified fMRI brain scanning examinations and standardized motor function as well as speech function quantitative evaluation assessments at two fixed time nodes, including the baseline time point before intervention initiation and the follow-up time point after all intervention courses are completed." **Procedures** _(From the protocol)_: - MRI scan (Non-invasive) > "The stimulation target is the bilateral subthalamic nucleus, with individualized electrode placement and current intensity determined via personalized modeling based on each patient's magnetic resonance imaging (MRI) data." **Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long. **Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered. _Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._ ## 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") ## Eligibility - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: 1. Idiopathic Parkinson's disease diagnosed by neurologists according to the Movement Disorder Society Clinical Diagnostic Criteria; 2. Hoehn and Yahr stage 1.5-3.0; 3. Stable levodopa-based antiparkinsonian medication for at least 4 weeks before enrolment, with no planned medication change during the trial period; 4. Ability to walk independently; 5. Ability to understand and follow study instructions and complete the required assessments, with no severe cognitive impairment as screened by the Montreal Cognitive Assessment and/or Mini-Mental State Examination according to prespecified thresholds; 6. Willingness to participate and provide written informed consent. Exclusion Criteria: 1. Any contraindication to MRI or tTIS, including claustrophobia or ferromagnetic intracranial or subcutaneous implants; 2. Significant systemic disease that could increase study risk or interfere with trial participation; 3. Neurological disorders other than Parkinson's disease; 4. Major psychiatric disorder or severe depression or anxiety; 5. History of deep brain stimulation surgery; 6. Inability or unwillingness to complete all interventions and assessments. ``` ## Locations (1) - Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China _(23.1167, 113.2500)_ - Liu Hanjun, (CONTACT), +86 15920175118, lhanjun@mail.sysu.edu.cn ## Central Contacts - Dan Zi, (CONTACT), +8618922465578, 925343654@qq.com - Liu Hanjun, (CONTACT), +86 15920175118, lhanjun@mail.sysu.edu.cn ## 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. --- *Canonical: https://parkinsonspathways.com/trial/NCT07721688* *HTML version: https://parkinsonspathways.com/trial/NCT07721688* *Source data: https://clinicaltrials.gov/study/NCT07721688*