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Completed

NCT Number: NCT07572903

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Temporal Interference Stimulation

Other

Temporal Interference Stimulation

Primary outcomes

  1. The part III of MDS-Unified Parkinson's Disease Rating Scale

    Time frame: Baseline,Immediately after a single stimulation

Secondary outcomes

  1. Hoehn-Yahr Stage Scale

    Time frame: Baseline,Immediately after a single stimulation

  2. 3-Meter Timed Up and Go Test

    Time frame: Baseline,Immediately after a single stimulation

  3. 10-meter walking test

    Time frame: Baseline,Immediately after a single stimulation

  4. Upper and lower limb alternation

    Time frame: Baseline,Immediately after a single stimulation

  5. Clinical Global Impression

    Time frame: Baseline,Immediately after a single stimulation

    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).

  6. Resting-state electroencephalogram(rsEEG)

    Time frame: Baseline,Immediately after a single stimulation

  7. Transcranial Magnetic Stimulation-Electroencephalography(TMS-EEG)

    Time frame: Baseline,Immediately after a single stimulation

    Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a technique used to assess cortical excitability and causal network connectivity.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Official study title

The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease: A Three-arm, Randomized, Double-blind, Parallel-controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 7, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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