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Personalized iTBS in Real-World Clinical Settings for Schizophrenia

NCT07176468 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-30

No results posted yet for this study

Summary

This study is designed to determine whether neuronavigation-guided, personalized Intermittent Theta-Burst Stimulation (iTBS) can produce clinically benefits for patients with schizophrenia when delivered in real-world treatment settings. By situating the intervention within real-world treatment settings-without imposing restrictions on concurrent pharmacotherapy-this trial seeks to generate evidence that is both scientifically rigorous and clinically relevant.

The main questions it seeks to address are:

Does the personalized iTBS target TMS protocol improve clinical symptoms in patients with schizophrenia within real-world treatment settings? What neural circuit changes, as assessed by functional MRI, occur following TMS treatment?

Participants will:

Undergo personalized,personalized iTBS target treatment daily for 2 weeks. Complete baseline and post-treatment assessments, including clinical symptom scales (PANSS, HAMA, HAMD) and neuropsychological tests (MoCA, DST, VFT, Stroop Test, and AVLT).

Have structural and resting-state functional MRI scans before and after treatment.

Be monitored for any treatment-related adverse events.

Conditions

Interventions

OTHER

Neuronavigation-guided individualized iTBS

Participants will receive individualized iTBS for 14 consecutive days in addition to their usual medication regimen. iTBS parameters: 50 Hz bursts every 200 ms (5 Hz), 2s on/8s off, total 600 pulses per session;6 sessions/day (3 in morning, 3 in afternoon, 3600 pulses/day); 100% RMT intensity; Neuronavigation: Brainsight system (Rogue Research, Canada)

Sponsors & Collaborators

  • Anhui Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2026-09-20
Completion
2026-09-20

Countries

  • China

Study Locations

More Related Trials

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 NCT07176468 on ClinicalTrials.gov