Brain Stimulation for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method where an electrode is placed inside the skull to stimulate a brain area involved in mood regulation. It targets patients with severe depression who haven't improved with other treatments. The goal is to see if this method can reduce their depression symptoms. This new treatment option is being scientifically evaluated for patients with major depression who have not responded to conventional treatments.
Will I have to stop taking my current medications?
You won't have to stop taking your current medications, but you will need to keep them the same for the first four months of the study. After that, you can change your medications if needed.
Is intracalvarial prefrontal cortical stimulation (IpCS) safe for humans?
Research on transcranial direct current stimulation (tDCS), a similar non-invasive brain stimulation technique, shows it is generally safe with low and temporary side effects, though some studies report minor skin issues. However, a home-based study was stopped early due to safety concerns, highlighting the need for careful monitoring.12345
How is Intracalvarial Prefrontal Cortical Stimulation (IpCS) different from other depression treatments?
Intracalvarial Prefrontal Cortical Stimulation (IpCS) is unique because it involves direct stimulation of the brain's prefrontal cortex, potentially offering a more targeted approach compared to non-invasive methods like transcranial direct current stimulation (tDCS), which uses weak electrical currents applied externally to the scalp.678910
What data supports the effectiveness of the treatment INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) for depression?
Research on a similar treatment, transcranial direct current stimulation (tDCS), shows it can reduce depression symptoms significantly. Studies found that tDCS applied to the prefrontal cortex led to a notable decrease in depression scores, with improvements seen as early as two weeks into treatment.37101112
Who Is on the Research Team?
Jon T Willie, MD, PhD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults aged 21-80 with severe depression that hasn't improved after trying at least two different types of antidepressants. They must have had some response to non-invasive neurostimulation, not be pregnant or able to become pregnant, and be capable of undergoing brain scans and cognitive tests.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Device Placement and Initial Stimulation
Placement of neurostimulation device and initial stimulation of the prefrontal cortex
Treatment
Intermittent activation of intracalvarial cortical stimulation to modulate brain regions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS)
INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) is already approved in United States for the following indications:
- Severe Treatment-Resistant Depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inner Cosmos Inc
Lead Sponsor
Washington University School of Medicine
Collaborator