NCT05100888

Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms

Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms: a Double-blind, Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The major target of the study is to confirm the safety and efficacy of our augmented protocol of theta-burst TMS in schizophrenia. Our aim is to confirm the beneficial effects of rTMS treatment on multiple aspects of the disorder such as (1) clinical aspect in terms of PANSS, (2) cognitive aspect such as emotion recognition (ER) and working memory (WM) / distractor filtering (DF) performance, and (3) neurobiology in terms of electrophysiology correlates of ER, WM and DF such as ERPs, event related theta synchronization, resting state theta power, and network connectivity. Response prediction to (theta-burst) TB-rTMS will be the exploratory part of the study.

Detailed description

Response prediction will be based on spectral slope, individual alpha peak, and frontal alpha asymmetry, calculated from baseline resting-state EEG in the closed-eye condition (the open-eye condition may also be used). Baseline resting-state fMRI will also be used to predict responses.

Conditions

• Transcranial Magnetic Stimulation Repetitive
• Schizophrenia

Interventions

Type	Name	Description
DEVICE	repetitive Transcranial Magnetic Stimulation (rTMS)	Theta-burst stimulation

Timeline

• Start date: 2022-07-11
• Primary completion: 2026-03-24
• Completion: 2026-03-24
• First posted: 2021-10-29
• Last updated: 2026-03-30

Locations

1 site across 1 country: Hungary