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NCT Number: NCT07312279

Study on the Efficacy of Temporal Interference Stimulation (TIS) for Parkinson's Disease

The primary objective of this clinical study is to evaluate the therapeutic efficacy of Temporal Interference Stimulation (TIS), a non-invasive deep brain stimulation technique, in patients with Parkinson's disease, and to further investigate its potential mechanisms of action. Although TIS offers lower stimulation intensity and precision compared to conventional Deep Brain Stimulation (DBS), it possesses the distinct advantage of being non-invasive. This study utilizes TIS to explore different stimulation targets analogous to those used in DBS for Parkinson's disease, thereby providing valuable insights for subsequent DBS surgical interventions. The findings will contribute preliminary exploratory evidence regarding the application of non-invasive deep brain stimulation technology in the treatment of Parkinson's disease.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult males or females aged 40 years or above;
  • Diagnosed with idiopathic Parkinson's disease according to the UK Brain Bank Criteria, with onset after 40 years of age;
  • Previous or current dopaminergic replacement therapy (e.g., levodopa) with good response; (4) Hoehn and Yahr (H&Y) stage 1.5-2.5;
  • Ability to walk independently without assistive devices for at least 5 minutes;
  • Absence of severe freezing of gait (FOG);
  • Disease duration ≥2 years since diagnosis, with stable clinical condition and ability to comply with study assessments and interventions;
  • Stable medication dosage for at least 4 weeks prior to the study;
  • Hoehn and Yahr (H&Y) stage 1.5-2.5;
  • Signed informed consent, with the participant or legal guardian capable of understanding and willing to participate in the study.

Exclusion criteria

  • Presence of other neurological disorders that may interfere with the study
  • Mild or greater cognitive impairment (MoCA score ≤23)
  • Orthopedic or other health conditions that may affect gait or balance
  • Contraindications to MRI scanning, such as claustrophobia
  • History of antipsychotic, antidepressant, or other medications that may affect dopamine levels
  • Other significant psychiatric history
  • Contraindications including history of epilepsy, traumatic brain injury, or implanted metal devices in the brain or heart (e.g., stimulators, pacemakers)
  • History of electroconvulsive therapy
  • Concurrent participation in other gait- or balance-related intervention training
  • Physician-diagnosed cardiovascular risk factors for exercise.

Treatment and study plan

TIS

Device

Temporal Interference Stimulation

Primary outcomes

  1. UPDRS-3

    Time frame: From enrollment through the 3-month follow-up

    Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) scores from baseline to immediately after and 1 month after a single treatment session.

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

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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