NCT04318977

rTMS Add on Value for Amelioration of Negative Symptoms of Schizophrenia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of Regensburg · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Treatment of depression with repetitive transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. The treatment of negative symptoms with the same protocol in schizophrenia is considered as possible effective. Theta burst stimulation is a new protocol which is characterized by shorter sessions showing first evidence that it's efficacy is comparable to the high-frequency rTMS. In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated.

Detailed description

In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated. The active study arms are high-frequency rTMS and iTBS of the left dorsolateral prefrontal cortex to treat negative symptoms in schizophrenia. The control arm will include the same number of patients as each active arm and includes both sham rTMS and sham iTBS in the same proportion as the active treatments. Standards of the trial will be harmonized across four clinical centers with the aim to pool data for analysis. Each center is responsible for ethical approval and adherence to good clinical practice by itself (Sponsor). Interim analysis: Several meta-analyses of the effect of rTMS/iTBS on negative symptoms in schizophrenia showing heterogeneous effect sizes have been published since begin of the trial. Thefore, an interim analysis after inclusion of at least 15 patients in each arm was added to the protocol. In case of null findings and low effect sizes (no differences of either rTMS or TBS vs. sham in the primary outcome), the trial will be terminated.

Conditions

• Negative Symptoms With Primary Psychotic Disorder
• Schizophrenia

Interventions

Type	Name	Description
DEVICE	high-frequency rTMS	repetitive transcranial magnetic stimulation
DEVICE	TBS	theta burst stimulation
DEVICE	placebo	placebo transcranial magnetic stimulation

Timeline

• Start date: 2020-02-01
• Primary completion: 2024-08-14
• Completion: 2025-12-30
• First posted: 2020-03-24
• Last updated: 2025-09-19

Locations

4 sites across 2 countries: Czechia, Germany