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NCT03693105 · ClinicalTrials.gov registry record · Phase 2
The Effects of SAINT® Neuromodulation System on Explicit and Implicit Suicidal Cognition
A Phase 2 study, sponsored by Magnus Medical.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT03693105: Clinical Trial Phase 2 study, sponsored by Magnus Medical.
NCT03693105 is a Phase 2 study that was terminated before completion, run by Magnus Medical. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03693105, a Phase 2 study, was terminated before completion, sponsored by Magnus Medical.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This multi-site, double-blind, randomized, sham-controlled mechanistic trial aims to test the effects of Magnus Neuromodulation System (MNS) with Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) Technology on the neural circuitry of suicidal cognitions in psychiatrically hospitalized patients with Major Depressive Disorder (MDD) and active suicidal ideation (SI). This will be accomplished by applying the MNS with SAINT to a customized target within the left dorsolateral prefrontal cortex (L-DLPFC) identified with fMRI for five consecutive days and measuring resting-state functional connectivity (RS FC) between the subgenual anterior cingulate cortex (sgACC) and the default mode network (DMN) at baseline and immediate-post visit. The relationship between changes in RS FC and changes in both Explicit and Implicit Suicidal Cognitions (ESC and ISC, respectively) will be determined. This study will also determine the relationship between changes in RS FC in neural networks underlying mediators of suicidal cognitions and changes in such mediators with active versus sham SAINT.
Primary Outcome
We will assess resting state functional connectivity between sgACC and the DMN and within the DMN using magnetic resonance imaging.
Interventions
- DEVICE Sham SAINT Stimulation
- DEVICE Active SAINT Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2024-06-30 |
| Est. Completion | 2025-03-06 |
| Phase | Phase 2 |
Why NCT03693105 stopped before completion
NCT03693105 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham SAINT Stimulation is the first listed.
NCT03693105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03693105 about?
NCT03693105 is a clinical study titled "The Effects of SAINT® Neuromodulation System on Explicit and Implicit Suicidal Cognition". This multi-site, double-blind, randomized, sham-controlled mechanistic trial aims to test the effects of Magnus Neuromodulation System (MNS) with Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) Technology on the neural circuitry of suicidal cognitions in psychiatrically hospitaliz...
What is the current status of trial NCT03693105?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2024-06-30. Estimated completion is 2025-03-06.
What interventions are being tested in trial NCT03693105?
The interventions under investigation include: Sham SAINT Stimulation (DEVICE), Active SAINT Stimulation (DEVICE).
Who is sponsoring clinical trial NCT03693105?
This trial is sponsored by Magnus Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03693105's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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