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

NCT ID: NCT07173920

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-08
• Study Completion Date: 2028-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation

Intervention Type: 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 sham repetitive Transcranial Magnetic Stimulation (rTMS)

Group Type: PLACEBO_COMPARATOR

repetitive Transcranial Magnetic Stimulation

Intervention Type: 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.

Interventions

repetitive 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.

Intervention Type: DEVICE

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Sixth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xie Bingyan

Ms.XIE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Sixth Hosptial

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

bingyan xie

Role: CONTACT

xie@bjmu.edu.cn

18715644290

Facility Contacts

bingyan xie

Role: primary

xie@bjmu.edu.cn

18715644290

Other Identifiers

2025-08-13-4

Identifier Type: -

Identifier Source: org_study_id