Actively Recruiting
Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder
Led by Pulvinar Neuro, LLC · Updated on 2025-04-16
40
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
Sponsors
P
Pulvinar Neuro, LLC
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research study is to study a closed-loop transcranial alternating current stimulation (tACS) device to evaluate feasibility of the product in a clinical trial and collect preliminary data on potential effects on symptoms of depression in people with major depressive disorder.
CONDITIONS
Official Title
Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender, aged 18 - 70
- Provided signed and dated informed consent
- Willing to follow all study procedures and available for the study duration
- Diagnosed with unipolar, non-psychotic major depressive disorder per DSM-5
- Hamilton Depression Rating Scale (HDRS-17) score of 14 or higher
- Low suicide risk with no active ideation in past month and no attempts or significant self-harm in past 2 years
- Able to understand study risks and benefits (informed consent)
- For those able to become pregnant, using highly effective contraception for at least 1 month before screening and agreeing to continue during study
You will not qualify if you...
- Severe alcohol use disorder diagnosed within last 12 months
- Moderate to severe substance use disorder (excluding tobacco) diagnosed within last 12 months
- Lifetime history of bipolar disorder
- Diagnosis of schizophrenia spectrum or other psychotic disorders
- History of autism spectrum disorder
- Started new psychotropic medication or changed dose in last 6 weeks
- Started new psychotherapy in last 6 weeks
- Received neurostimulation treatment in last 6 weeks
- History of seizures (except childhood febrile seizures or ECT-induced seizures)
- Neurological disorders increasing risk or confounding results (e.g., dementia, stroke, Parkinson's, multiple sclerosis, serious brain injury, ruptured aneurysm, CNS radiation)
- Failed to respond to ECT or transcranial magnetic stimulation
- Prior brain surgery or brain implants
- Implanted electrical medical device
- Currently pregnant or breastfeeding
- Enrolled in another depression clinical trial
- Contraindication to MRI (for optional MRI session)
- Unstable medical conditions or other safety concerns per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
Research Team
A
Athena Stein, PhD
CONTACT
Z
Zachary Stewart
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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