TIS for Improving Cognitive Impairment in Schizophrenia

NCT07647380 · tracked via the Priya Life Science China tracker

Sponsor

Central South University

Phase

Not applicable

Started

2026-06-24

Last updated

2026-07-17

Condition(s) studied

Schizophrenia DisorderCognitive Impairments

Investigational drug(s) / intervention(s)

temporal interference stimulationSham stimulation

temporal interference stimulation: TIS will use 2 pairs of electrodes placed according to a 10-10 EEG system and fixed with conductive paste to produce a theta burst stimulation pattern. Electric field modeling will be performed utilizing MRI T1 images to optimize the individualized electrode configuration to generate electric field intensities above 0.6 V/m in the hippocampus of each patient. Each session of stimulation lasts 30 minutes.

Sham stimulation: The sham stimulation only includes a 15-second ramp-up at the start and ramp-down at the beginning of each stimulus, which could simulate the scalp pulsing sensation caused by the change of current at the beginning and end of the stimulus.

Study summary

This study aims to evaluate the efficacy, safety, and underlying neural mechanisms of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Researchers will compare active TIS to a sham control to see if TIS works to treat CIAS. Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, E/I imbalance index recorded by EEG, and MRI data, will be collected at baseline, at the end of the 2-week intervention, and 4 weeks after the intervention.

Eligibility

Sex

ALL

Min age

18 Years

Max age

50 Years

Healthy volunteers

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.

Primary outcome measure(s)

changes on the MATRICS Consensus Cognitive Battery (MCCB) scores — Baseline, after 2-week intervention, 4 weeks post-treatment
The MATRICS Consensus Cognitive Battery (MCCB) can be used for cognitive assessment of schizophrenia, bipolar disorder, and other neuropsychiatric diseases. The MCCB covers nine cognitive domains, including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function, and fine motor skills. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test.

Trial sites (1)

Facility	City	Region	Status
Second Xiangya Hospital, Central South University	Changsha	Hunan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07647380 on ClinicalTrials.gov ↗ ← All trials in China