About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.;
Trial design
Treatments tested in this trial
- Temporal Interference Stimulation