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Effects of Respiratory-Gated Transcutaneous Vagal Nerve Stimulation in Major Depression (Phase 1)
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
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
3,023 Previous Clinical Trials
13,317,934 Total Patients Enrolled
193 Trials studying Depression
34,062 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