Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium - Maintenance

Starting soon · Not applicable

Conditions studied: Major Depressive Disorder (MDD)

In brief

The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif XCS System when used as indicated for treatment-resistant depression (TRD).

Key facts

Study ID: NCT07684794
Run by: Motif Neurotech, Inc.
People needed: 10
Starts: 2026-08-10
Expected to finish: 2027-12-31
Last updated by the study team: 2026-07-06

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has a diagnosis of unipolar non-psychotic Major Depressive Disorder (MDD) and is currently experiencing a major depressive episode (MDE) as defined by 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

You may not qualify if…

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
Has a history of bipolar disorder
Has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder
Has psychotic features in the current depressive episode
Has a chronic and clinically significant neurological disorder (epilepsy, dementia, delirium, amnestic disorder, brain tumor), or neuroimaging findings that would potentially impact the efficacy of treatment (e.g., extensive white matter disease, demyelinating lesions, atrophy, brain tumor)
Currently taking medication that would alter the seizure threshold, increasing potential seizure risks
Has a history of brain injury that resulted in current cognitive impairment
Has a history of bony disorders that impact the safe and effective use of the device as well as device implantation
Has a history of skin disorders that impact the safe and effective use of the device as well as device implantation
Has failed all attempts to achieve at least 50% reduction in depressive symptoms after completion of approved treatment courses of electroconvulsive therapy (ECT) or TMS for treatment of MDD
Is planning to receive any other neuromodulation therapy (e.g., ECT, TMS, tDCS, tACS, DBS, VNS, or focused ultrasound) during the study
Meets the DSM-5 criteria for alcohol use disorder or other substance use disorder (not including tobacco/nicotine) within 12 months prior to study enrollment or, in the opinion of the investigator, is using illicit drugs recreationally or therapeutically which could impact the safety or effectiveness of the therapy
Female who is pregnant at the time of inclusion, or planning to become pregnant during the duration of the study, or not willing to use an effective method of birth control
Has a life expectancy less than 12 months
In the opinion of the investigator, is considered to be acutely suicidal (e.g., Type 4 or 5 on the C-SSRS)
In the investigator's opinion, any known comorbidity that would complicate the assessment of safety or prevent participation in follow-up visits
Before implantation of the Motif DOT Implant, subjects must continue to meet all study eligibility criteria. Subjects must also meet the following additional criteria:
Psychiatric treatment regimen has remained stable
Has skull thickness ≥5.5 mm and ≤15.5 mm over the implant target

Full record on ClinicalTrials.gov

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