RecruitingNot ApplicableNCT07658898

dACC-Targeted Temporal Interference for Negative and Cognitive Symptoms in Schizophrenia

A Randomized Controlled Trial Exploring the Efficacy of Temporal Interference Stimulation for Negative Symptoms and Cognitive Impairment in Schizophrenia


Sponsor

Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University

Enrollment

74 participants

Start Date

Jun 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized, double-blind, sham-controlled trial aims to evaluate the efficacy and safety of dorsal anterior cingulate cortex-targeted temporal interference stimulation in individuals with schizophrenia. Participants will be randomly assigned to receive either active or sham stimulation for 10 sessions over two consecutive weeks. The primary outcome is the change in negative symptoms, assessed using the Negative Symptom Subscale of the Positive and Negative Syndrome Scale. Cognitive performance, detailed dimensions of negative symptoms, psychosocial functioning, quality of life, and treatment-related adverse events will also be evaluated. Neuroimaging assessments will be conducted before and after the intervention to explore potential neural mechanisms underlying the clinical effects of temporal interference stimulation.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sham Temporal Interference Stimulation and a medical device called Temporal Interference Stimulation for people with schizophrenia disorder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETemporal Interference Stimulation

Participants will receive active temporal interference stimulation targeting the dorsal anterior cingulate cortex. Two high-frequency alternating currents at 2000 Hz and 2006 Hz will be delivered using an individualized electrode configuration determined by electric field modeling. Each session will last 30 minutes. Treatment will be administered five times per week for two consecutive weeks, for a total of 10 sessions.

DEVICESham Temporal Interference Stimulation

Participants will receive sham temporal interference stimulation using the same electrode placement and session schedule as the active stimulation group. Brief ramp-up and ramp-down periods will be applied to mimic the sensations associated with active stimulation, but sustained temporal interference stimulation will not be delivered. Each session will last 30 minutes. Treatment will be administered five times per week for two consecutive weeks, for a total of 10 sessions.


Locations(1)

Shanghai Pudong New Area Mental Health Center

Shanghai, China

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NCT07658898


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