Tardive DyskinesiaNCT07173920
Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
A study testing repetitive Transcranial Magnetic Stimulation in people with Tardive Dyskinesia and Repetitive Transcranial Magnetic Stimulation, run by Peking University Sixth Hospital at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tardive Dyskinesia, Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Sixth Hosptial
Beijing
bingyan xie, 18715644290, xie@bjmu.edu.cn
About this study
Official title: A Single-Center, Double-Blind, Randomized, Placebo-Controlled Clinical Study on the Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation (rTMS) Under Precise Localization for Relieving Motor Symptoms of Tardive Dyskinesia
# 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.
Read more
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.
- Being tested
- repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treating tardive dyskinesia (TD) with active repetitive Transcranial Magnetic Stimulation (rTMS) | Experimental | Not described Receives: Device: repetitive Transcranial Magnetic Stimulation |
| Treating tardive dyskinesia (TD) with sham repetitive Transcranial Magnetic Stimulation (rTMS) | Placebo comparator | Not described Receives: Device: repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use the Abnormal Involuntary Movement Scale (AIMS) to assess the improvement in abnormal movements in patients with tardive dyskinesia (TD)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start8 Sep 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Bingyan, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173920
- Sponsor's protocol ID
- 2025-08-13-4
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Blind, Randomized, Placebo-Controlled Clinical Study on the Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation (rTMS) Under Precise Localization for Relieving Motor Symptoms of Tardive Dyskinesia
- ClinicalTrials.gov ID
- NCT07173920
- Acronym / sponsor ID
- 2025-08-13-4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
# 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive Transcranial Magnetic StimulationPatients 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. | Device | Treating tardive dyskinesia (TD) with active repetitive Transcranial Magnetic Stimulation (rTMS), Treating tardive dyskinesia (TD) with sham repetitive Transcranial Magnetic Stimulation (rTMS) |
Primary outcome
Use the Abnormal Involuntary Movement Scale (AIMS) to assess the improvement in abnormal movements in patients with tardive dyskinesia (TD)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation in people with Tardive Dyskinesia and Repetitive Transcranial Magnetic Stimulation, run by Peking University Sixth Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact bingyan xie (18715644290, xie@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use the Abnormal Involuntary Movement Scale (AIMS) to assess the improvement in abnormal movements in patients with tardive dyskinesia (TD) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.