RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Motif XCS System for Major Depressive Disorder

The objective of this study is to measure the safety, tolerability, and preliminary how well it works of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).

Official registry: https://clinicaltrials.gov/study/NCT07594483 · Motif Neurotech, Inc. · enrollment listed as 20

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Motif XCS System. The registry lists allocation as na. The objective of this study is to measure the safety, tolerability, and preliminary how well it works of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).

They plan to enroll about 20 people at 4 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium

Interventions: Motif XCS System

Primary outcome (registry wording): Incidence of device and/or procedure-related adverse events (AEs)

Who it is for (from inclusion criteria)

Ages 22 Years to 85 Years
Has a diagnosis of unipolar non-psychotic Major Depressive Disorder (major depression) 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 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

Who the registry excludes

Has a cranial implant (with the exception of dental implants), neurostimulator, implanted medication pump, spinal cord stimulator, or pacemaker/implantable cardioverter-defibrillator
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

Public study contact (from the registry)

Brandon Thio

201-381-1534

support@motifneuro.tech

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

Emory Healthcare — Atlanta, Georgia (recruiting)
University of Iowa — Iowa City, Iowa (recruiting)
UTHealth Houston — Houston, Texas (recruiting)
Brain Health Consultants and TMS Center — Houston, Texas (recruiting)

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FAQ about this NCT record

Is NCT07594483 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07594483?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07594483?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary