Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07173920

Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation (rTMS) with Precise Localization for Motor Symptoms in Tardive Dyskinesia: A Randomized, Double-Blind, Placebo-Controlled Study

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

62

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Tardive Dyskinesia (TD) is a movement disorder caused by long-term use of dopamine receptor blockers and related drugs. It results in involuntary movements that persist and cause lasting neurological damage, significantly impacting patients' daily functioning. Researchers are evaluating whether repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, can improve motor symptoms in people with TD. This study focuses on a specific rTMS mode called continuous theta-Burst Stimulation (cTBS), which may offer more lasting benefits through precise brain targeting. Participants will receive rTMS treatment for 14 days using cTBS. Before treatment, they will undergo an MRI scan to create a personalized brain map, allowing precise localization of the stimulation areas in the motor and sensory networks. The study includes two groups: one receiving active rTMS and the other receiving sham (placebo) rTMS. This design allows comparison to assess the treatment's effect on TD motor symptoms under double-blind conditions. During the study, participants will be regularly assessed using the Abnormal Involuntary Movement Scale (AIMS) over two years to measure changes in abnormal movements. Researchers will monitor safety and treatment effects throughout this period. Participation involves MRI scans, rTMS sessions, and follow-up visits to evaluate motor symptoms and overall response to the intervention.

CONDITIONS

Brief 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
  • Diagnosis of tardive dyskinesia based on Schooler-Kane criteria
  • Disease duration of at least 3 months before screening
  • History of treatment with dopamine receptor antagonists for at least 3 months (or at least 1 month if aged 60 years or older)
  • No other diseases causing involuntary movements
Not Eligible

You will not qualify if you...

  • Diagnosis of movement disorders other than tardive dyskinesia
  • History of focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or higher) on prior MRI/CT
  • Personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsants for seizures
  • Presence of metallic medical devices, metallic foreign bodies, or implanted electronic devices
  • Contraindications to repetitive Transcranial Magnetic Stimulation (rTMS)
  • Contraindications to MRI scanning such as metallic implants or claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Approximately 14 days

Participants undergo an MRI scan for precise localization before receiving repetitive Transcranial Magnetic Stimulation (rTMS) treatment targeting motor symptoms of tardive dyskinesia.

Daily visits for up to 14 days

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored for improvement in abnormal movements using the Abnormal Involuntary Movement Scale (AIMS).

Visits scheduled periodically over 2 years

Trial Site Locations

Total: 1 location

1

Peking University Sixth Hosptial

Beijing, China

Actively Recruiting

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Research Team

B

bingyan xie

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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