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

NCT07173920 | Recruiting

• 1 other identifier: 2025-08-13-4
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tardive Dyskinesia; Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

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

  2 years

Study Arms (2)

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

EXPERIMENTAL

Device: repetitive Transcranial Magnetic Stimulation

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

PLACEBO COMPARATOR

Device: repetitive Transcranial Magnetic Stimulation

Interventions

repetitive Transcranial Magnetic Stimulation DEVICE

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.

Treating tardive dyskinesia (TD) with active repetitive Transcranial Magnetic Stimulation (rTMS); Treating tardive dyskinesia (TD) with sham repetitive Transcranial Magnetic Stimulation (rTMS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

Sponsors & Collaborators

• Peking University Sixth Hospital: lead

Study Sites (1)

Peking University Sixth Hosptial

Beijing, China

RECRUITING

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

bingyan xie

CONTACT

18715644290; xie@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms.XIE

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)