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Active transcutaneous vagus nerve stimulation for Depression

N/A
Waitlist Available
Led By Ronald G Garcia, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours

Summary

This trial will test if sending mild electrical pulses to a nerve in the neck can help people with major depression by improving their heart function, mood, and immune system.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cardiac autonomic function
Change in depressive symptoms assessed by the Beck Depression Inventory
Secondary study objectives
Change in serum levels of pro-inflammatory cytokines

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tVNS - 8 HzExperimental Treatment1 Intervention
Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 8 Hz stimulation frequency
Group II: Active tVNS - 30 HzExperimental Treatment1 Intervention
Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 30 Hz stimulation frequency
Group III: Active tVNS - 2 HzExperimental Treatment1 Intervention
Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 2 Hz stimulation frequency
Group IV: Active tVNS - 100 HzExperimental Treatment1 Intervention
Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 100 Hz stimulation frequency
Group V: Sham tVNSPlacebo Group1 Intervention
Sham transcutaneous vagus nerve stimulation on the left auricle

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,309,416 Total Patients Enrolled
192 Trials studying Depression
33,942 Patients Enrolled for Depression
Brain & Behavior Research FoundationOTHER
62 Previous Clinical Trials
2,906 Total Patients Enrolled
21 Trials studying Depression
1,165 Patients Enrolled for Depression
Ronald G Garcia, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
80 Total Patients Enrolled
~3 spots leftby Nov 2025
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