Trial results for an EEG synchronized Transcranial Magnetic Stimulation (TMS) study for depression were posted on ClinicalTrials.gov on 2025-08-14, indicating no significant difference in remission rates with a p-value of 0.6.
Background
Depression is a common mental health condition. Transcranial Magnetic Stimulation (TMS) is a treatment option that typically involves delivering pulses to the prefrontal cortex. The rationale behind this study explored whether timing these TMS pulses with the brain's natural rhythms, specifically its EEG phase, could enhance treatment effectiveness. This concept draws a parallel to cardiology, where knowing the heart's rhythm and phase is crucial for effective cardioversion.
Trial design
This Phase 2/Phase 3 trial enrolled 34 participants with Depression. The study compared two approaches to Transcranial Magnetic Stimulation (TMS): EEG Synchronized TMS (SYNC TMS) and Non-Synchronized TMS (Non-Sync TMS). The investigation aimed to determine if timing brain stimulation with the individual's brain phase, such as the alpha frequency rhythm, would impact treatment outcomes.
Key results
The trial reported on two key measurements:
- Remission Rate:
- In the SYNC TMS group, 2 participants achieved remission.
- In the Non-Sync TMS group, 3 participants achieved remission.
- Number of Participants With EEG Phase Synchronization Frequency Changes:
- In the SYNC TMS group, 3 participants showed changes.
- In the Non-Sync TMS group, 1 participant showed changes.
A Chi-squared analysis was performed for the categorical clinical remission data. This analysis yielded a p-value of 0.6.
What this means
The analysis of remission rates, with a p-value of 0.6, suggests that there was no statistically significant difference in clinical remission between EEG synchronized TMS and non-synchronized TMS in this study. While the study also measured EEG phase synchronization frequency changes, the primary analysis for clinical remission did not demonstrate a benefit for the synchronized approach. These results indicate that, based on this trial, synchronizing TMS pulses with brain rhythms may not significantly improve remission outcomes for patients with depression compared to traditional TMS.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03421808, titled "EEG Synchronized TMS Trial for Depression", were posted on 2025-08-14 on clinicaltrials.gov.
