NCT07572903Completed
The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease
The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease: A Three-arm, Randomized, Double-blind, Parallel-controlled Study
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
This study aimed to evaluate the clinical efficacy and safety of temporal interference stimulation (TIS) targeting different targets in patients with Parkinson's disease (PD), and to investigate the associated neurophysiological mechanisms. A three-arm, randomised, double-blind, parallel-group design was employed, consisting of a right globus pallidus internus (GPi) stimulation group, a right subthalamic nucleus (STN) stimulation group, and a sham stimulation group. PD patients in the OFF-medication state (≥12 hours after the last dopaminergic dose) were randomly assigned to receive either active TIS targeting the GPi or STN, or sham stimulation, with each session lasting 30 minutes. Clinical symptom assessments were conducted before and immediately after the intervention, and safety was monitored throughout by the research team.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 27 Apr 2026
- Start date
- 6 May 2026
- Primary completion date
- 16 Jul 2026
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Diseases
- Parkinson disease
- NCT number
- NCT07572903
What you commit to
- Study type: Interventional
- Participants enrolled: 96
- From 6 May 2026 to the primary completion date, 16 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or above) on previous head MRI/CT scans;
- Severe craniocerebral trauma, cranial surgery or deep brain stimulation treatment;
Other illness
- Various secondary Parkinson's syndromes (vascular Parkinson's syndrome, drug-induced Parkinson's syndrome, etc.);
- Ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.;
- A history of epilepsy, unexplained loss of consciousness, or taking anticonvulsant drugs for epileptic seizures;
- Diagnosed with neuropsychiatric diseases other than Parkinson's disease;
- A history of drug abuse or drug use;
Other
- Participated in any clinical trial in the past 3 months;
- Pregnant/lactating women or subjects (including men) who plan to have children within 6 months;
- Other situations that the researchers consider unsuitable for inclusion.
Who the study is looking for
- Age \>= 40 years;
- Meet the diagnostic criteria for primary Parkinson's disease (MDS Parkinson's Disease Diagnostic Criteria (2015 Edition));
- No medication adjustment in the 4 weeks before and during each stimulation;
- MDS-UPDRS III score \>= 8 points, Hoehn-Yahr score 1-4 points
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.