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RecruitingNCT07173920Updated Dec 5, 2025

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

An interventional study of repetitive Transcranial Magnetic Stimulation in Tardive Dyskinesia and Repetitive Transcranial Magnetic Stimulation, sponsored by Peking University Sixth Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Peking University Sixth Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

# 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.

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Conditions studied

  • Tardive Dyskinesia
  • Repetitive Transcranial Magnetic Stimulation

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In context

Tardive Dyskinesia

58 studies on the registry are indexed under Tardive Dyskinesia; 9 are open to participants now.

This study's planned enrollment of 62 is close to the median of 60 across 48 interventional studies indexed under Tardive Dyskinesia.

Browse Tardive Dyskinesia studies →

Lead sponsor

Peking University Sixth Hospital is the lead sponsor of 19 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • (1) Age between 18 and 65 years; (2) Patients whose diagnosis is consistent with the tardive dyskinesia (TD) diagnostic criteria defined by the Schooler-Kane criteria, with a disease duration of at least 3 months before screening, and a history of treatment with dopamine receptor antagonists for at least 3 months (a minimum of 1 month for patients aged ≥ 60 years); other diseases that may cause involuntary movements are excluded

Exclusion Criteria:(1) Diagnosed with movement disorders other than tardive dyskinesia (TD); (2) A history of focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or higher) identified on previous head MRI/CT; (3) A personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant medications for seizure management; (4) Presence of metallic medical devices in the body (e.g., cardiac pacemakers, cochlear implants), other metallic foreign bodies, or any electronic devices implanted in the body; or having other contraindications to repetitive Transcranial Magnetic Stimulation (rTMS); (5) Presence of contraindications to MRI scanning, such as having metallic implants in the body or claustrophobia

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Treating tardive dyskinesia (TD) with active repetitive Transcranial Magnetic Stimulation (rTMS)

    Device: repetitive Transcranial Magnetic Stimulation

  • Placebo comparator
    Treating tardive dyskinesia (TD) with sham repetitive Transcranial Magnetic Stimulation (rTMS)

    Device: repetitive Transcranial Magnetic Stimulation

Interventions

  • Devicerepetitive Transcranial Magnetic Stimulation

    Patients will receive rTMS treatment for a total of 14 days. Prior to treatment, patients will undergo an MRI scan; the images will be preprocessed to construct a structural network, and precise localization of the pre-SMA (preSupplementary Motor Area) region and the SCAN (Somatosensory-Cognitive-Action Network) will be performed based on coordinates.

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What researchers measure

Primary outcomes

  1. Use the Abnormal Involuntary Movement Scale (AIMS) to assess the improvement in abnormal movements in patients with tardive dyskinesia (TD)

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Peking University Sixth Hosptial
    Beijing, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07173920
Lead sponsor
Peking University Sixth Hospital
Responsible party
Xie Bingyan (Ms.XIE, Peking University Sixth Hospital) — Principal investigator
First posted
Sep 15, 2025
Start date
Sep 8, 2025
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Dec 5, 2025

Study contacts

bingyan xie
Contact
xie@bjmu.edu.cn
18715644290

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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