Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium - Maintenance
- Sponsor
- Motif Neurotech, Inc.
- Study ID
- NCT07684794
- Status
- Not Yet Recruiting
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Conditions
- Major Depressive Disorder (MDD)
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Motif XCS System — DEVICEThe 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.
Study Details
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 Dates
- First listed
- Jul 6, 2026
- Start date
- Aug 10, 2026
- Status verified
- Jul 2026
- Primary completion
- Nov 1, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 10 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
- Catherine Lapp201-381-1534
- Esther Elliott+61 (0) 405 916 797
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