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 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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson s Disease
• Intervention / Treatment: Other: Temporal Interference Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junjun Wu; Phone Number: +86 0551 62923704; Email: 2445011385@stu.ahmu.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Junjun Wu; Phone Number: +86 0551 62923704; Email: 2445011385@stu.ahmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham group	Other: Temporal Interference Stimulation; Temporal Interference Stimulation
Experimental: GPi group	Other: Temporal Interference Stimulation; Temporal Interference Stimulation
Experimental: STN group	Other: Temporal Interference Stimulation; Temporal Interference Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The part III of MDS-Unified Parkinson's Disease Rating Scale	Baseline，Immediately after a single stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hoehn-Yahr Stage Scale		Baseline，Immediately after a single stimulation
3-Meter Timed Up and Go Test		Baseline，Immediately after a single stimulation
10-meter walking test		Baseline，Immediately after a single stimulation
Upper and lower limb alternation		Baseline，Immediately after a single stimulation
Clinical Global Impression	CGI comprehensively quantifies the severity of a patient's illness and the net benefit of treatment by assessing disease severity (CGI-S), overall improvement (CGI-I), and the balance between efficacy and side effects (Efficacy Index EI).	Baseline，Immediately after a single stimulation
Resting-state electroencephalogram（rsEEG）		Baseline，Immediately after a single stimulation
Transcranial Magnetic Stimulation-Electroencephalography（TMS-EEG）	Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a technique used to assess cortical excitability and causal network connectivity.	Baseline，Immediately after a single stimulation

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Temporal Interference Stimulation; Parkinson s Disease
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: AHMU-single TIS-PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No