Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium

Sponsor
Motif Neurotech, Inc.
Study ID
NCT07594483
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 85 Years
Healthy Volunteers
Not accepted

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

Study Details

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).

Key Dates

First listed
May 18, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Motif XCS System

Primary Outcome Measure

Incidence of device and/or procedure-related adverse events (AEs) [ Time Frame: During procedure to 12 months follow-up ]

Central Contacts

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