Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07173920

Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD

Led by Peking University Sixth Hospital · Updated on 2025-12-05

62

Participants Needed

1

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

\# Brief Summary (English Version) Tardive Dyskinesia (TD) is a hyperkinetic movement disorder induced by long-term use of dopamine receptor blockers and related drugs. Characterized by involuntary spasms or choreiform movements involving the tongue, lower face, jaw, and limbs (persisting for at least several weeks), TD causes irreversible neurological damage that persists even after discontinuing the causative drugs, significantly impairing patients' functional outcomes. rTMS is a non-invasive neuromodulation technique: time-varying currents in a coil generate magnetic fields that penetrate the scalp and skull to act on brain neurons, inducing depolarization, neural network activation, neurotransmitter release, metabolic changes, and gene expression, thereby producing physiological effects \[9\]. In recent years, rTMS has gained attention for treating movement disorders (e.g., Parkinson's disease, motor neuron disease, dystonia, essential tremor, Huntington's disease) due to its non-invasiveness, high safety, and repeatability. Studies have reported that rTMS can significantly improve motor symptoms in TD patients \[10, 11\]; however, existing research is limited by small sample sizes, conventional treatment parameters, large inter-individual variability, and unclear long-term efficacy. rTMS efficacy in TD is strongly influenced by parameters including stimulation targets, localization methods, sequences, and cycles. Optical navigation (using personalized MRI) is the most accurate and yields the best therapeutic effects, compared to manual localization or positioning caps . Regarding stimulation sequences, 1Hz and 20Hz rTMS have shown efficacy but with short-lived effects. Continuous theta-Burst Stimulation (cTBS)-a specialized rTMS mode that delivers rapid pulse trains mimicking endogenous theta-wave bursts-provides higher therapeutic doses in less time, enabling more durable efficacy and effectively reducing motor cortex excitability . Therefore, this study aims to investigate the effect of cTBS (under precise localization) on improving motor symptoms in patients with TD.

CONDITIONS

Official Title

Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Diagnosed with tardive dyskinesia according to Schooler-Kane criteria
  • Disease duration of at least 3 months before screening
  • History of dopamine receptor antagonist treatment for at least 3 months (minimum 1 month if age 60 or older)
  • No other diseases causing involuntary movements
Not Eligible

You will not qualify if you...

  • Diagnosed with movement disorders other than tardive dyskinesia
  • History of focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or higher) on prior MRI/CT
  • History of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant drugs for seizures
  • Presence of metallic medical devices or other contraindications to rTMS
  • Contraindications to MRI, such as metallic implants or claustrophobia

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Peking University Sixth Hosptial

Beijing, China

Actively Recruiting

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Research Team

B

bingyan xie

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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