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Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium

ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-85
SponsorMotif Neurotech, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 dorsolateral prefrontal cortex (DLPFC), without penetrating the dura.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Motif XCS SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
During procedure to 12 months follow-up

Secondary outcomes

1

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

MADRS Scale: 0-60 (higher score indicates worse outcome)

Time frame
After treatment to 12 months follow-up
2

The incidence of stimulation-induced side effects

Time frame
After treatment to 12 months follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Motif Neurotech, Inc.

Lead sponsor

Bright Research Partners

Collaborator

Source ClinicalTrials.gov
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