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Efficacy and Mechanism of Subthalamic Nucleus–Targeted Noninvasive Deep Brain Stimulation (TI) for the Treatment of Tardive Dyskinesia in Schizophrenia

Efficacy and Mechanism of Subthalamic Nucleus–Targeted Noninvasive Deep Brain Stimulation (TI) for the Treatment of Tardive Dyskinesia in Schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112914
Enrollment
Unknown
Registered
2025-11-20
Start date
2025-11-20
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Tardive Dyskinesia

Interventions

Sponsors

Tianjin Anding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years, inclusive, regardless of sex; 2. Diagnosed by the study physician as experiencing an episode of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), whether first episode or recurrent; 3. A medical history of treatment with a dopamine receptor blocking agent for at least 3 months; 4. Scores on the Abnormal Involuntary Movement Scale (AIMS) meet the criterion of at least two items rated >= 2 or at least one item rated >= 3; 5. No change in schizophrenia medication regimen within 30 days prior to signing the informed consent form until the trial period; 6. The patient's involuntary movements are not caused by neurological diseases such as Parkinson's disease, Huntington's chorea, or oral and facial abnormalities due to edentulism; 7. Possesses a certain level of listening, speaking, reading, writing, and comprehension skills, capable of completing study assessments; 8. Based on the judgment of the research physician, the subject understands the purpose and procedures of the study, is able to comply with the study protocol requirements, and can sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals with a history of other psychiatric disorders, neurological diseases, or substance abuse that, in the researcher's judgment, may affect the assessment of the study's efficacy; 2. Individuals with a history of epilepsy or previous seizure episodes; 3. Individuals with metal foreign objects in the cranial cavity or metal implants in the heart; 4. Individuals with organic brain disease, a history of severe head injury, or previous head surgeries; 5. Individuals who have undergone electroconvulsive therapy (ECT) or other physical treatments (e.g., transcranial magnetic stimulation, transcranial electrical stimulation, etc.) within the past 30 days; 6. Individuals with a HAMD (Hamilton Depression Rating Scale) suicide item score of 3 or higher; 7. Individuals currently pregnant, breastfeeding, or planning to conceive during the trial period; 8. Individuals currently participating in other interventional clinical trials; 9. Any other situation deemed unsuitable for participation in the study by the researcher.

Design outcomes

Primary

MeasureTime frame
Symptoms of tardive dyskinesia;

Secondary

MeasureTime frame
Adverse event;Quality of life;Positive and Negative Syndrome;Functional magnetic resonance imaging (fMRI);Changes in electroencephalogram (EEG) signals;Cognitive function;Antipsychotic-induced extrapyramidal symptoms (EPS);Depression symptom;Anxiety symptom;Degree of akathisia severity;

Countries

China

Contacts

Public ContactShen Li

Tianjin Anding Hospital

lishen@tmu.edu.cn+86 13752115075

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026