The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD
Launched by YANGHUA TIAN · Apr 9, 2025
Trial Information
Current as of November 13, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This trial is studying whether a non-invasive brain treatment called transcranial temporal interference stimulation (tTIS) aimed at the right globus pallidus internus (GPi) can improve motor symptoms in people with Parkinson’s disease. In this randomized, double‑blind study, about 40 adults will receive either real tTIS for 10 days or a sham (fake) treatment. Motor symptoms are checked using the MDS-UPDRS scale while people are on their usual Parkinson’s medications, with assessments on Day 1, Day 10, and about a month after the treatment. Researchers will also look at emotional symptoms, using scales for anxiety and depression.
Who can participate and what to expect: Adults aged 50–80 with Parkinson’s disease (diagnosed by two neurologists), at various stages (Hoehn‑Yahr 1.5–4), and who have been stable on their meds for about four weeks can be considered. Participants must be right‑handed, have no significant depression or dementia, and not have other neuropsychiatric conditions or implants that would interfere with the study. The trial is taking place at Anhui Medical University in Hefei, China, and is currently enrolling by invitation. If you join, you’ll be randomly assigned to real or sham tTIS for 30 minutes per session, with careful monitoring of motor and emotional symptoms; results are not yet available, and this is an early study to assess safety and potential benefit.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Meeting the diagnostic criteria for Parkinson's disease in China (2016 version), diagnosed as PD by two neurologists;
- • 2. Hoehn-Yahr stage 1.5-4;
- • 3. Age \> 50 years old;
- • 4. No signs of moderate to severe depression: Beck Depression Inventory-II (BDI-II) score \< 20;
- • 5. No signs of dementia: Mini-Mental State Examination (MMSE) score \> 21;
- • 6. No change in medication regimen in the four weeks prior to enrollment;
- • 7. Right-handed.
- Exclusion Criteria:
- • 1. History of other neuropsychiatric disorders;
- • 2. History of alcohol or drug abuse;
- • 3. Previous history of TMS or traditional TES treatment;
- • 4. Presence of non-MRI compatible metal implants in the body, such as deep brain stimulation devices, pacemakers or stents.
About Yanghua Tian
Yanghua Tian is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing safe and effective therapies, Yanghua Tian collaborates with leading research institutions and healthcare professionals to facilitate clinical trials that adhere to the highest ethical and regulatory standards. The organization prioritizes patient safety and data integrity, striving to contribute meaningful advancements in the treatment of various health conditions. Through rigorous oversight and a commitment to scientific excellence, Yanghua Tian aims to enhance healthcare outcomes and improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hefei, Anhui, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported