Improve movement and speech function
- 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 movement and speech function
- 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
Summary For Families
The goal is to improve motor symptoms like slowness and tremor, plus vocal problems, by targeting the subthalamic nucleus, a deep brain area that contributes to movement and speech issues in Parkinson's and secondary parkinsonism. The approach uses accelerated temporal interference stimulation, a noninvasive electrical technique that mixes two high-frequency currents to produce a low-frequency effect deep in the brain, modulating neuronal firing in the subthalamic nucleus much like deep brain stimulation but without surgery, and it is intended to complement usual meds such as levodopa rather than replace them. The trial seeks about 60 adults with mild to mid-stage disease, Hoehn and Yahr stage 1.5 to 3, who can walk independently, have no cognitive impairment or prior DBS, can undergo MRI, and are generally under 80 years old.
Locations
- Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Temporal Interference Stimulation. The goal is to improve motor symptoms like slowness and tremor, plus vocal problems, by targeting the subthalamic nucleus, a deep brain area that contributes to movement and speech issues in Parkinson's and secondary parkinsonism. The approach uses accelerated temporal interference stimulation, a noninvasive electrical technique that mixes two high-frequency currents to produce a low-frequency effect deep in the brain, modulating neuronal firing in the subthalamic nucleus much like deep brain stimulation but without surgery, and it is intended to complement usual meds such as levodopa rather than replace them. The trial seeks about 60 adults with mild to mid-stage disease, Hoehn and Yahr stage 1.5 to 3, who can walk independently, have no cognitive impairment or prior DBS, can undergo MRI, and are generally under 80 years old.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 8 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.