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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

Awards & highlights

Study Summary

This trial will test if electrical stimulation of the vagus nerve can help improve symptoms of depression, by measuring changes in heart rate and immune function.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cardiac autonomic function

Change in depressive symptoms assessed by the Beck Depression Inventory

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,340 Total Patients Enrolled

185 Trials studying Depression

29,556 Patients Enrolled for Depression

Brain & Behavior Research FoundationOTHER

61 Previous Clinical Trials

2,799 Total Patients Enrolled

20 Trials studying Depression

1,135 Patients Enrolled for Depression

Ronald G Garcia, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being invited to take part in this medical experiment?

"Affirmative, the clinicaltrial.gov website confirms that this research is now recruiting individuals to participate in its protocols. This trial was first posted on November 2nd 2020 and has recently been updated as of March 9th 2022; it seeks 20 participants from one specific location."

Answered by AI

What eligibility criteria must potential participants meet in order to join this trial?

"This experiment is in search of 20 adults aged 24 to 45 struggling with melancholia. To be considered eligible, participants must have a previous diagnosis of Major Depressive Disorder and an active depressive episode at the time of enrolment; furthermore, they should not have been taking psychiatric medications for past 30 days or be on any stable therapeutic dosage prior to joining this research effort."

Answered by AI

Is this experiment accepting new participants at present?

"Correct. According to clinicaltrials.gov, this medical study began recruiting on November 2nd 2020 and is still ongoing; 20 participants are sought from a single site."

Answered by AI

Are individuals aged 45 and above able to participate in this medical research?

"This research trial is specifically searching for patients between the ages of 24 and 45. By contrast, there are 107 clinical trials available for minors under 18 years old and 594 studies that cater to those over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Respiratory-Gated Transcutaneous Vagal Nerve Stimulation in Major Depression (Phase 1)

Ronald Garcia 2020. "Effects of Respiratory-Gated Transcutaneous Vagal Nerve Stimulation in Major Depression (Phase 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04607226.