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
The First Affiliated Hospital of Anhui Medical University
90 participants
May 6, 2026
INTERVENTIONAL
Conditions
Summary
This study aimed to observe the clinical efficacy and safety of single-target transcranial temporal stimulation (tTIS) intervention in Parkinson's disease (PD) patients and explore the neurophysiological mechanism of TIS intervention. The study was designed as a three-arm (A: GPi group, B: STN group, C: Sham group), randomized, double-blind, parallel-controlled trial. PD patients in the drug-off state (≥12 hours after drug withdrawal) were randomly assigned to receive either tTIS or sham stimulation targeting GPi/STN, with each stimulation lasting 30 minutes. Clinical symptom assessments were conducted before and after the intervention, and safety was monitored by researchers throughout the process.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria10
- Focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or above) on previous head MRI/CT scans;
- Various secondary Parkinson's syndromes (vascular Parkinson's syndrome, drug-induced Parkinson's syndrome, etc.);
- Severe craniocerebral trauma, cranial surgery or deep brain stimulation treatment;
- 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;
- 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.
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Interventions
Temporal Interference Stimulation
Locations(1)
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NCT07572903