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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125966
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

schizophrenia

Interventions

Intervention group:Temporal Interference
Control group:Temporal Interference

Sponsors

Tianjin Anding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 70 years, regardless of sex; 2.Diagnosed with schizophrenia (first-episode or relapse) by a study physician according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3.Have a history of treatment with dopamine receptor blockers for at least 3 months; 4.The Abnormal Involuntary Movement Scale (AIMS) score meets at least 2 items = 2 points or at least 1 item = 3 points; 5.No changes to the schizophrenia treatment plan within 30 days prior to signing the informed consent and throughout the study period; 6.The involuntary movements exhibited by the patient are not caused by neurological disorders such as Parkinson’s disease, Huntington’s disease, or oral and facial abnormalities due to edentulism; 7.Possess sufficient ability in listening, speaking, reading, writing, and comprehension to complete the study scales; 8.Based on the study physician's judgment, the subject understands the purpose and procedures of this study, is able to comply with the protocol requirements, and can sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Presence of other psychiatric disorders, neurological disorders, or a history of substance abuse that, as judged by the investigator, may affect the determination of study efficacy; 2.History of seizures or previous epileptic convulsions; 3.Presence of metallic foreign objects in the head or metallic implants in the heart; 4.Presence of organic brain disease, history of severe head trauma, or history of head surgery; 5.Received electroconvulsive therapy or other physical treatments (e.g., transcranial magnetic stimulation, transcranial electrical stimulation) for the head within the last 30 days; 6.A score of 3 or greater on the suicide item of the Hamilton Depression Rating Scale (HAMD); 7.Currently pregnant, breastfeeding, or planning to conceive during the study period; 8.Currently participating in other clinical interventional trials; 9.Any other conditions deemed inappropriate for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Abnormal Involuntary Movement Scale;

Secondary

MeasureTime frame
Positive and Negative Syndrome Scale;Barnes Akathisia Rating Scale;World Health Organization Quality of Life;EEG;Extrapyramidal Symptom Rating Scale;MATRICS Consensus Cognitive Battery;MRI;Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale;Adverse events;

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: Jun 11, 2026