Trial results for a study assessing biomarker changes in Schizophrenia were posted on ClinicalTrials.gov on 2026-01-09, with 10 participants enrolled.
Background
Schizophrenia is a chronic and severe mental disorder affecting how a person thinks, feels, and behaves. It is characterized by a range of symptoms, including delusions, hallucinations, disorganized speech, and impaired cognitive function. Current treatments often involve antipsychotic medications, but these do not always fully address all symptoms, and some patients experience significant side effects. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has been explored for its potential therapeutic effects in various neurological and psychiatric conditions, including schizophrenia spectrum disorders (SSD). This study aimed to assess specific biomarkers related to SSD before and after rTMS administration to better understand its physiological impact.
Trial design
This completed study, designated as Phase NA, enrolled 10 participants to assess biomarker changes in individuals with Schizophrenia and Schizophrenia Schizoaffective disorder. Participants were exposed to both active and sham repetitive transcranial magnetic stimulation (rTMS) in separate sessions. The trial's objective was to assess schizophrenia spectrum disorder-related biomarkers before and after rTMS administration.
Key results
The trial results detailed changes in key biomarkers:
- Change of Resting-state Functional Connectivity (rsFC) by Active and Sham rTMS:
- For the Active rTMS group, the mean change was 0.018 (Standard Error: 0.018) z score of functional connectivity.
- For the Sham rTMS group, the mean change was 0.007 (Standard Error: 0.027) z score of functional connectivity.
- Change of Mismatch Negativity (MMN) From Electroencephalography (EEG) Signals by Active and Sham rTMS:
- For the Active rTMS group, the mean change was -0.106 (Standard Error: 0.367) microvolts.
- For the Sham rTMS group, the mean change was 0.044 (Standard Error: 0.217) microvolts.
What this means
This study provides initial data on how repetitive transcranial magnetic stimulation (rTMS) affects specific biomarkers in individuals with schizophrenia spectrum disorders. The observed mean changes in resting-state functional connectivity (rsFC) were 0.018 for active rTMS and 0.007 for sham rTMS, measured as a z score of functional connectivity. For mismatch negativity (MMN) from EEG signals, the mean change was -0.106 microvolts for active rTMS and 0.044 microvolts for sham rTMS. Given the small sample size of 10 participants and the exploratory nature of biomarker assessment, these findings contribute to understanding the physiological impact of rTMS, but do not yet indicate clinical efficacy or direct therapeutic benefit. Further research with larger cohorts would be needed to determine the clinical significance of these biomarker changes and their potential correlation with symptom improvement.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05660018, titled "TMS Related Biomarker Assessments", were posted on 2026-01-09 on clinicaltrials.gov.