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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Temporal Interference Stimulation
Other interventionTemporal Interference Stimulation
Treatment groups
Trial outcomes
Primary outcomes
The part III of MDS-Unified Parkinson's Disease Rating Scale
Secondary outcomes
Hoehn-Yahr Stage Scale
3-Meter Timed Up and Go Test
10-meter walking test
Upper and lower limb alternation
Sponsors and contacts
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