The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorThe First Affiliated Hospital of Anhui Medical University

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

Treatment groups

90 Participants
are divided into 3 treatment groups