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

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.

Inclusion Criteria:

1. Age >= 40 years;
2. Meet the diagnostic criteria for primary Parkinson's disease (MDS Parkinson's Disease Diagnostic Criteria (2015 Edition));
3. No medication adjustment in the 4 weeks before and during each stimulation;
4. MDS-UPDRS III score >= 8 points, Hoehn-Yahr score 1-4 points

Exclusion Criteria:

1. Focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or above) on previous head MRI/CT scans;
2. Various secondary Parkinson's syndromes (vascular Parkinson's syndrome, drug-induced Parkinson's syndrome, etc.);
3. Severe craniocerebral trauma, cranial surgery or deep brain stimulation treatment;
4. Ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.;
5. A history of epilepsy, unexplained loss of consciousness, or taking anticonvulsant drugs for epileptic seizures;
6. Diagnosed with neuropsychiatric diseases other than Parkinson's disease;
7. A history of drug abuse or drug use;
8. Participated in any clinical trial in the past 3 months;
9. Pregnant/lactating women or subjects (including men) who plan to have children within 6 months;
10. Other situations that the researchers consider unsuitable for inclusion.