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The Efficacy and Safety of Non-invasive Deep Brain Stimulation (TI) for Cognitive Impairment in Schizophrenia: A Randomized Controlled Trial

The Efficacy and Safety of Non-invasive Deep Brain Stimulation (TI) for Cognitive Impairment in Schizophrenia: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102724
Enrollment
Unknown
Registered
2025-05-19
Start date
2025-05-27
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Schizophrenia

Interventions

Sponsors

Tianjin Anding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Applicants must be between 18 and 65 years old (inclusive), regardless of gender; 2. Patients diagnosed with episodes of schizophrenia by the study physician in accordance with the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), with no limitation on the first episode or recurrence; 3. Patient's PANSS negative scale score>=20 points; 4. The patient's MCCB-T score < 40 points; 5. No change in schizophrenia medication regimen within 30 days prior to signing the informed consent form until the trial period; 6. Have certain listening, speaking, reading, writing and comprehension skills, and be able to complete the research scale; 7. According to the judgment of the study doctor, the subject understands the purpose and procedures of this study, is able to comply with the requirements of the study protocol and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of other psychiatric disorders, neurological diseases, or substance abuse, as determined by the investigator to potentially interfere with efficacy evaluation; 2. History of epileptic seizures or documented epileptic convulsions; 3. Presence of metallic implants in the skull or cardiac devices (e.g., pacemakers); 4. Diagnosed with organic brain diseases, or history of severe head trauma or cranial surgery; 5. Received intracranial electroconvulsive therapy (ECT) or other physical therapies (e.g., transcranial magnetic stimulation [TMS], transcranial electrical stimulation) within the past 30 days; 6. A score =3 on the suicide item of the 17-item Hamilton Depression Rating Scale (HAMD-17); 7. Currently pregnant, breastfeeding, or planning pregnancy during the trial period; 8. Concurrent participation in another interventional clinical trial; 9. Any other condition deemed by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Cognitive function;

Secondary

MeasureTime frame
Negative symptom;Anxiety symptom;Quality of life;Adverse event;Sleep quality;Positive and Negative Syndrome;Resting-State Functional Magnetic Resonance Imaging;Depression symptom;

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