Plain-English translation of NCT05393622 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing intracalvarial prefrontal cortical stimulation (IpCS), a minimally invasive procedure in which a small electrode is placed above the inner table of the skull to deliver gentle electrical stimulation to a specific brain region involved in mood. Researchers believe this treatment may help people with severe depression that has not responded to at least two different types of antidepressant medications. The study will track up to 20 participants for one year to see if the treatment is safe and reduces depression symptoms.
Many people with severe depression do not get relief from standard antidepressant medications, even after trying multiple drugs at adequate doses. This trial exists to test whether directly stimulating a brain region known to control mood can provide relief for these people when other treatments have failed.
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You will undergo neurosurgery to have the stimulation device implanted above the inner table of your skull—a minimally invasive procedure. After implant, the device will be turned on and off periodically to stimulate your prefrontal cortex. You will visit the clinic regularly over the course of one year to have your depression and cognitive symptoms measured using rating scales and questionnaires, allowing researchers to monitor both the safety and effectiveness of the treatment.
AI-generated summary from trial data · Jun 11, 2026 · Not medical advice
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