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Noninvasive Brain Stimulation

Soterix Medical mini-CT tDCS stimulator for Major Depressive Disorder

Phase 1
Waitlist Available
Led By Abhishek Datta, PhD
Research Sponsored by Soterix 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 weeks 1-10. patients who receive maintenance sessions will also report at the end of weeks 11-18, 20, 22, 24, 26, 28, 30
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a home-use device that sends gentle electrical signals to the brain can safely and effectively improve mood in adults with unipolar depression.

Eligible Conditions
  • Depression
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1-10. patients who receive maintenance sessions will also report at the end of weeks 11-18, 20, 22, 24, 26, 28, 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1-10. patients who receive maintenance sessions will also report at the end of weeks 11-18, 20, 22, 24, 26, 28, 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Mood
Secondary study objectives
Adverse Effects: Pain
Adverse Effects: Suicidal Ideation
Columbia Suicide Severity Rating Scale (C-SSRS)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active tDCSExperimental Treatment1 Intervention
Active Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soterix Medical mini-CT tDCS stimulator
2021
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

NYU Langone HealthOTHER
1,408 Previous Clinical Trials
855,735 Total Patients Enrolled
Soterix MedicalLead Sponsor
10 Previous Clinical Trials
325 Total Patients Enrolled
Abhishek Datta, PhDPrincipal InvestigatorSoterix Medical Inc.
2 Previous Clinical Trials
85 Total Patients Enrolled
~11 spots leftby Nov 2025
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