TBS-AH

Behandlung auditorischer Halluzinationen bei Schizophrenie mit bilateraler Theta Burst Stimulation - Fortsetzungsantrag

01.12.2021 bis 30.11.2024

Auditory verbal hallucinations (AH), a cardinal symptom of schizophrenia, are severely distressing and increase the risk for violence and suicide. Their perception is associated with increased activity in speech-related temporoparietal areas of the brain. In up to 25%-30% of patients, AH resist therapeutic efforts. Repetitive transcranial magnetic stimulation (rTMS) can reduce focal brain hyperactivity and, applied to the left temporoparietal cortex, has been shown to ameliorate AH. However, controlled multicentre clinical trials are still missing, effect sizes are moderate, and the treatment is time-consuming. With continuous theta burst stimulation (cTBS), an advanced form of rTMS with brief stimulation sessions is available for a quicker and potentially more effective modulation of cortical hyperactivity and associated AH. With this multicentre, sham-controlled clinical trial, we aim at providing evidence for the efficacy and safety of cTBS in the treatment of AH in patients with schizophrenia. Patients will receive a three weeks course of daily (5/week) cTBS or sham treatment to the left and right temporoparietal cortex (1200 impulses daily). Sham stimulation will be applied by an active sham-coil that allows for a double-blind treatment. Efficacy on AH will be compared between both groups by the PSYRATS-AH subscale at the end of treatment. Secondary endpoints are psychotic symptom severity (PANSS), global functioning (GAF), and clinical global impression (CGI). Follow-up assessments 1, 3 and 6 months after treatment will investigate the stability of treatment effects.
This study refers to stage II of TBS-AH, which relied on an adaptive design. After the interim analysis, the sample size adaptation resulted in a total number of 137 patients (the initial sample size resulted in n=86).