Actively Recruiting
Intracalvarial Prefrontal Cortical Stimulation in Treatment-Resistant Depression
Led by Inner Cosmos Inc · Updated on 2026-04-15
20
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Inner Cosmos Inc
Lead Sponsor
W
Washington University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intracalvarial prefrontal cortical stimulation (IpCS), a minimally invasive brain stimulation device placed above the skull, for people with severe treatment-resistant depression (TRD). This study focuses on patients diagnosed with major depressive disorder who have not responded to at least two different antidepressant treatments and have had brief responses to non-invasive brain stimulation. The goal is to see if IpCS targeting the dorsolateral prefrontal cortex can reduce depression symptoms over time. Participants will have the neurostimulation device surgically implanted under the skull near the dorsolateral prefrontal cortex. The device will intermittently stimulate this brain area to affect mood regulation. This is an open trial enrolling up to 20 people with severe depression, followed for up to one year. During the study, participants will receive continuous brain stimulation and be monitored for changes in depression and cognitive function. Throughout the study, participants will undergo regular assessments including brain scans (CT and MRI), cognitive testing, and depression rating scales such as the Montgomery-Asberg Depression Rating Scale (MADRS). Researchers will track changes in depression symptoms over 12 months compared to the start of the study. Safety and cognitive effects will also be evaluated periodically. The study includes a baseline testing period before implantation and continuous follow-up to monitor participant health and device impact.
CONDITIONS
Brief Title
Brain Stimulation for Severe Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have chronic (2 or more years) or recurrent depression and currently experiencing a major depressive episode as defined by DSM V criteria
- Have a baseline Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or higher
- Have not had a sustained response to two or more adequately dosed antidepressant treatments from at least two different classes in the current episode
- Completed baseline testing including CT and MRI brain scans and cognitive testing before implant surgery
- Female participants must not be pregnant, agree to use birth control, or be unable to become pregnant
- Be between 21 and 80 years old
- Able to complete study evaluations including brain imaging
- Able to provide written informed consent and sign the consent form
You will not qualify if you...
- If the implant or procedure poses unacceptable surgical or medical risk
- Expected to require full body MRI during the study
- Acutely suicidal within 30 days before implant surgery
- History of schizophrenia, schizoaffective disorder, or psychotic depression
- Have neurological disorders such as epilepsy, dementia, delirium, or cognitive impairment
- History of brain injury causing cognitive impairment
- History of bony disorders affecting bone density or device implantation
- Female participants with a positive pregnancy test
- Taking monoamine oxidase inhibitors that pose anesthesia risks
- Disagreement to hold current pharmacotherapy constant for 4 months post enrollment
- Presence of frontal bone thickening over 20mm at the electrode implantation site seen on CT scan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial surgical procedure plus continuous device stimulation
Participants have a neurostimulation device placed in the skull and receive continuous stimulation to relieve symptoms of depression.
1 surgical visit (in-person)
Duration - Up to 12 months
Participants are monitored after device placement for effectiveness and safety, including assessments of depression symptoms and cognitive function.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
2
Washington University in St Louis School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
A
Arthur Gribetz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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