TIS for Improving Cognitive Impairment in Schizophrenia
Official title: Efficacy and Safety of Time Interference Stimulation on Cognitive Impairment in Patients With Schizophrenia
Run by Central South University · NCT07647380 · Data updated 2026-11-12
A noninvasive brain stimulation study tests whether Temporal Interference Stimulation can improve thinking skills in adults with schizophrenia and cognitive impairment, compared to a sham treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | June 24, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | March 30, 2027 |
| Registry record updated | July 17, 2026 |
| Trial ID | NCT07647380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-50 with schizophrenia for up to 8 years, stable antipsychotic dosing, and measurable cognitive impairment (GDS MCCB ≥ 0.5).
✕Probably not a fit
Individuals with comorbidities or conditions excluding deep-brain stimulation approaches, or those without sufficient MCCB deficits, may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial tests whether temporal interference stimulation (TIS) targeting the hippocampus can improve cognitive impairment in schizophrenia. Participants receive active TIS or sham stimulation twice daily for two weeks, with assessments at baseline, after treatment, and four weeks later. Researchers will measure cognitive performance, clinical symptoms, and neural markers from EEG and MRI to understand potential mechanisms such as excitatory–inhibitory balance. The study focuses on a deep-brain target to overcome limitations of surface stimulation and seeks to clarify safety and efficacy in CIAS.
Why it matters
Potential benefit: If successful, participants may experience improvements in cognitive functioning and daily living for schizophrenia-related cognitive impairment.
How similar studies have gone: Prior noninvasive brain stimulation approaches have shown mixed results; this study explores a novel deep-targeted method (TIS) with limited prior clinical data in CIAS.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-50 years old; * meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnostic criteria; * the diagnosis of schizophrenia is confirmed by the Structured Clinical Interview for DSM-5 (SCID-5); * the disease duration does not exceed 8 years; * 1-2 antipsychotic drugs are taken, and the treatment dose of antipsychotic drugs was stable for at least 1 week before enrollment. Mood stabilizers, antidepressants, and excessive benzodiazepines (lorazepam when 2 doses exceeded 2 mg/d) are not allowed; * The type of antipsychotic drugs remains unchanged during treatment, and the dose is adjusted by no more than 25%; * Impaired functioning in daily activities; * The Global Deficit Score (GDS) for the MATRICS Consensus Cognitive Battery (MCCB) reaches 0.5 or above; * Agree to participate in this study and provide written informed consent Exclusion Criteria: * Presence of other psychiatric comorbidities, intellectual disability, obvious mood symptoms, or substance use disorders (other than caffeine and/or tobacco); * with clear drug-induced extrapyramidal reaction; * A history of seizures, meningitis, or encephalitis; * with contraindications to transcranial electrical stimulation; * History of intracranial tumors or surgery; * history of severe head trauma; * have received other regimens of electrical or magnetic therapy in 1 month before enrollment.
Where it's running
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Second Xiangya Hospital, Central South University
Changsha, Hunan, China Recruiting
Study contacts
- Study coordinator: Renrong Wu
- Email: wurenrong@csu.edu.cn
- Phone: 15874179855
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.