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RECRUITING
NCT07647380
NA

TIS for Improving Cognitive Impairment in Schizophrenia

Sponsor: Central South University

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Time Interference Stimulation on Cognitive Impairment in Patients With Schizophrenia

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-06-24

Completion Date

2027-03-30

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

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.

Locations (1)

Second Xiangya Hospital, Central South University

Changsha, Hunan, China