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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University

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 (Actual): July 16, 2026
• Study Completion (Actual): 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): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 8, 2026
• Last Verified: July 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