Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium - Maintenance

NCT07684794 | Not Yet Recruiting

• 1 other identifier: TP-31
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Major Depressive Disorder (MDD)

Keywords

Depression; treatment resistant depression

Outcome Measures

Primary Outcomes (1)

• Incidence of device and/or procedure-related adverse events (AEs)

  During procedure to 12 months follow-up

Secondary Outcomes (2)

• Change in score on clinical outcome measures of treatment-resistant depression (Montgomery-Åsberg Depression Rating Scale [MADRS])

  After treatment to 12 months follow-up

• The incidence of stimulation-induced side effects

  After treatment to 12 months follow-up

Study Arms (1)

Motif XCS System

EXPERIMENTAL

Device: Motif XCS System

Interventions

Motif XCS System DEVICE

The Motif XCS System is a programmable device that delivers stimulation through surface electrodes implanted in a burr hole in the skull, positioned over the left DLPFC, without penetrating the dura.

Motif XCS System

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Motif Neurotech, Inc.: lead

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Esther Elliott

  Alithia Life Sciences

  STUDY DIRECTOR

Central Study Contacts

Catherine Lapp

CONTACT

201-381-1534; cate@motifneuro.tech

Esther Elliott

CONTACT

+61 (0) 405 916 797; esther.elliott@alithialifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 6, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share