Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder (NCT06874374) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder
United States40 participantsStarted 2025-04-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any gender, aged 18 - 70
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* DSM-5 diagnosis of unipolar, non-psychotic MDD as evidenced by the DIAMOND
* HDRS-17 score ≥14
* Low suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the C-SSRS screen and triage version with further exploration of positive responses.
* Capacity to understand all relevant risks and potential benefits of the study (informed consent)
* For people of childbearing potential: use of highly effective contraception as determined by the Investigator for at least 1 month prior to screening and agreement to use such a method during study participation
Exclusion Criteria:
* DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND
* DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND
* Lifetime history of bipolar disorder, as evidenced by DIAMOND
* Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND
* History of autism spectrum disorder
* Initiated any new psychotropic medication in the 6 weeks prior to screening or had a dose change in the precedi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be focused on testing whether a device can correctly deliver and log personalized brain stimulation based on EEG readings — rather than directly measuring whether depression symptoms improve — so should I understand this is more of a device validation study than a treatment trial, and what would that mean for my expectations of benefit?
2Since this trial uses transcranial alternating current stimulation (tACS) tailored to my individual brainwave patterns, can you explain how that differs from standard or non-individualized brain stimulation approaches, and whether there's existing safety data I should know about for this type of stimulation?
3The trial is listed as 'active not recruiting,' meaning they are no longer enrolling new participants — does that mean this specific study is not an option for me right now, and are there similar or follow-up studies you could refer me to?
4Given that the primary outcomes are all about device accuracy and technical performance rather than depression symptom relief, would you recommend I first consider other established treatments for my depression while research like this continues to develop?
5Since this appears to be a Phase NA study focused on device feasibility, what does that tell us about how early in the research process this technology is, and how would you weigh that uncertainty against my current treatment needs?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correct Assignment by Device of Study Arm
Timeframe: 5 days
2
Accuracy of Device Study Arm Parameters by Device
Timeframe: 5 days
3
Accuracy of Stimulation Initiation Based on EEG by Device
Timeframe: 5 days
4
Accuracy of Device Logs Uploaded to Cloud by Device