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

NCT07658898 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-08-21

No results posted yet for this study

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.

Conditions

  • Schizophrenia Disorder

Interventions

DEVICE

Temporal 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.

DEVICE

Sham 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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658898 on ClinicalTrials.gov