Trial results investigating at-home transcranial direct current stimulation (tDCS) for Major Depressive Disorder were posted on 2026-04-22. The study found that active stimulation was not superior to sham, with a statistically significant mean difference of 2.27 points on the Hamilton Depression Rating Scale (HDRS-17) (p=0.012) in favor of sham. The trial enrolled 174 participants.
Background
Major Depressive Disorder (MDD) is a common and serious mood disorder that significantly impacts daily life. While various treatments exist, including pharmacotherapy and psychotherapy, some individuals may not respond adequately or may experience side effects. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has been explored as a potential treatment option for depression, with interest in its feasibility for at-home use to improve accessibility and adherence.
Trial design
The completed Empower trial investigated whether active stimulation with the Flow FL-100 tDCS device was superior to sham stimulation for the treatment of Major Depressive Disorder when used at home. This study, which did not specify a phase, enrolled 174 participants diagnosed with Major Depressive Disorder. Participants performed up to 36 tDCS sessions by themselves without supervision during a blinded 10-week phase, followed by 30 more sessions during an unblinded open-label phase. The primary objective was to assess the superiority of active stimulation over sham based on changes in the Hamilton Depression Rating Scale (HDRS-17).
Key results
The trial's key measurements and analyses focused on the Hamilton Depression Rating Scale (HDRS-17), where lower scores indicate less severe depression:
- HDRS-17 - Hamilton Depression Rating Scale:
- For the Active Stimulation group, the mean score was 9.41 (Standard Deviation 6.25) units on a scale.
- For the Sham Stimulation group, the mean score was 7.14 (Standard Deviation 6.1) units on a scale.
A statistical analysis using a Mixed Model for Repeated Measures indicated a mean difference in final HDRS-17 values of 2.27 between the active and sham groups. This difference was statistically significant (p=0.012), with a 95.0% confidence interval ranging from 0.51 to 4.01.
What this means
The results of the Empower trial indicate that active tDCS using the Flow FL-100 device, when administered at home, was not superior to sham stimulation for individuals with Major Depressive Disorder. In fact, the statistically significant mean difference of 2.27 points on the HDRS-17 scale suggests that participants receiving sham stimulation achieved lower (better) depression scores than those receiving active stimulation. This outcome implies that the specific active tDCS intervention, as implemented in this study, did not demonstrate the intended therapeutic benefit over a placebo-like intervention.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05202119, titled "Empower: tDCS for Major Depressive Disorder at Home", were posted on 2026-04-22 on clinicaltrials.gov.