Actively Recruiting
The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease
Led by The First Affiliated Hospital of Anhui Medical University · Updated on 2026-05-12
90
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3E= 40 years
- Diagnosed with primary Parkinson's disease according to MDS 2015 criteria
- No medication changes for Parkinson's disease in the 4 weeks before and during stimulation
- MDS-UPDRS III score �3E= 8 points
- Hoehn-Yahr stage between 1 and 4 points
You will not qualify if you...
- Focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or above) on prior MRI/CT scans
- Secondary Parkinson's syndromes such as vascular or drug-induced Parkinson's syndrome
- Severe head trauma, brain surgery, or prior deep brain stimulation treatment
- Presence of ferromagnetic implants like cochlear implants or pacemakers
- History of epilepsy, unexplained loss of consciousness, or use of anticonvulsant drugs
- Neuropsychiatric diseases other than Parkinson's disease
- History of drug abuse
- Participation in any clinical trial within the past 3 months
- Pregnant or breastfeeding women, or planning to have children within 6 months
- Other conditions deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
Research Team
J
Junjun Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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