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Neuromodulation

SAINT® Stimulation for Depression (OLO Trial)

N/A
Recruiting
Research Sponsored by Magnus Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, 12 month follow up visit
Awards & highlights

Summary

The goal of this observational study is to demonstrate effectiveness in the treatment of Major Depressive Disorder The primary objective is to assess the effectiveness in the treatment of Major Depressive Disorder using the CGI-I at the end of the treatment Participants will receive 10 treatments per day for 5 days (M-F) of SAINT®

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, 12 month follow up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, 12 month follow up visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Clinical Global Impression Improvement Scale (CGI-I) score at the end of treatment (Day 5 SAINT® therapy)
Secondary study objectives
Cambridge Brain Science Tools assessment score change in comparison with change in MADRS scores from baseline to cessation of stimulation
Montgomery-Asberg Depression Rating Scale (MADRS) score change from baseline to cessation of stimulation in comparison with bioimaging assessments MADRS score change from baseline to cessation of stimulation in comparison with bioimaging assessments
To test the durability of the antidepressant effect by assessing the Clinical Global Impression Severity Scale (CGI-S) after cessation of stimulation
Other study objectives
Safety - Adverse Event Reporting assessment for causality and severity

Trial Design

1Treatment groups
Experimental Treatment
Group I: SAINT® StimulationExperimental Treatment1 Intervention
All participants will receive 10 treatments per day for 5 days (M-F) of SAINT® stimulation therapy.

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Who is running the clinical trial?

Magnus MedicalLead Sponsor
4 Previous Clinical Trials
250 Total Patients Enrolled
2 Trials studying Depression
50 Patients Enrolled for Depression
~571 spots leftby Oct 2026
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