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Efficacy and Safety of Temporal Interference Stimulation in Treatment-Resistant Schizophrenia: An Exploratory Study.

NCT07773831 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-19

No results posted yet for this study

Summary

This exploratory study aims to evaluate the preliminary efficacy and safety of temporal interference (TI) stimulation in patients with treatment-resistant schizophrenia (TRS). TI is a noninvasive brain stimulation technique that uses two high-frequency electrical currents with slightly different frequencies to generate a lower-frequency modulation at a targeted deep brain region.

A total of 20 patients with TRS will receive 130-Hz TI stimulation targeting the anterior limb of the internal capsule (ALIC). Stimulation will be delivered at a total current intensity of 4 mA for 5 consecutive days, with four 40-minute sessions per day. Participants will continue their stable antipsychotic medication regimen during the study.

Clinical symptoms, cognitive function, social functioning, and safety will be assessed before treatment, after completion of the 5-day treatment course, and at a 2-week follow-up. The primary clinical outcome is the change in the Positive and Negative Syndrome Scale (PANSS) total score. Secondary assessments include PANSS subscale scores, the MATRICS Consensus Cognitive Battery (MCCB), Calgary Depression Scale for Schizophrenia (CDSS), Personal and Social Performance Scale (PSP), and Clinical Global Impression (CGI). Safety will be evaluated through daily monitoring of treatment-related discomfort and adverse events.

Magnetic resonance imaging (MRI) will also be performed before and after treatment to explore treatment-related changes in brain structure, functional activity, functional connectivity, activation, and cerebral blood flow. The study hypothesizes that TI stimulation targeting the ALIC may improve clinical symptoms in patients with TRS and may be associated with measurable changes in neuroimaging markers.

Conditions

Interventions

DEVICE

Temporal Interference Stimulation

Participants with treatment-resistant schizophrenia will receive 130-Hz temporal interference stimulation targeting the anterior limb of the internal capsule (ALIC). Stimulation will be delivered at a total current intensity of 4 mA for 5 consecutive days, with four 40-minute sessions per day and a 20-minute interval between sessions.

Sponsors & Collaborators

  • Zhimin Wang

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-05-31
Completion
2027-07-31

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Entities

Diseases

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 NCT07773831 on ClinicalTrials.gov