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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Parkinson s Disease

In brief

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.

Key facts

Study ID

NCT07572903

Run by

The First Affiliated Hospital of Anhui Medical University

People needed

90

Starts

2026-05-06

Expected to finish

2026-08-01

Last updated by the study team

2026-07-20

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)

Full record on ClinicalTrials.gov

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