Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium (NCT07594483) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
20 participantsStarted 2026-05
Plain-language summary
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).
Who can participate
Age range
22 Years – 85 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
. Has a diagnosis of unipolar non-psychotic Major Depressive Disorder (MDD) and is currently experiencing a major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
. Has a screening Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥20
. Has not had a sustained response to 2 or more adequately dosed antidepressant treatments from at least 2 different antidepressant treatment classes in at least one episode of major depressive disorder, according to the Antidepressant Treatment History Form (ATHF)
. Is willing and able to provide written informed consent
. Is 22-85 years of age
. Is willing and able to comply with the protocol, including follow-up visits
. Has been on a stable psychiatric treatment regimen for 30 days before the study screening MADRS and is willing to maintain a stable psychiatric treatment regimen through the Week 4 follow-up visit
Exclusion criteria
. Has a cranial implant (with the exception of dental implants), neurostimulator, implanted medication pump, spinal cord stimulator, or pacemaker/implantable cardioverter-defibrillator
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.
1Since this trial's primary goal is to measure safety events related to the device and procedure rather than whether it actually improves depression symptoms, what does that mean for what I could realistically expect to gain or learn from participating?
2The trial isn't recruiting yet — how long might it be before it opens, and is there a reason to wait for it rather than starting one of the standard treatments available to me right now?
3What kind of device or stimulation procedure is involved in this study, and what are the known risks of having it implanted or used based on similar devices already studied?
4Because this is a Phase NA trial focused on adverse events, how does that differ from a trial that has already established whether a treatment works, and should that change how I weigh this option?
5If I were to eventually enroll and experienced a device-related adverse event, what support and follow-up care would be in place to address that?
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
Incidence of device and/or procedure-related adverse events (AEs)
Timeframe: During procedure to 12 months follow-up
. Has knowledge of planned magnetic resonance imaging (MRIs) in the next 12 months, after implant
. Is unable to undergo imaging with computed tomography (CT), magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), or functional magnetic resonance imaging (fMRI)
. In the opinion of the investigator, the implant and therapy pose an unacceptable surgical or medical risk to the patient
. Is currently taking blood thinners and cannot be taken off blood thinners
. Has taken ketamine or esketamine in the past 30 days or is planning on taking ketamine or esketamine before the 4-week follow-up visit
. Has taken hallucinogenic or dissociative medications in the past 30 days or is planning on taking hallucinogenic or dissociative medications for the treatment of mood or anxiety disorders before the 4-week follow-up visit