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Behavioural Intervention

tVNS for Depression (tVNS_MDD_Sex Trial)

N/A
Recruiting
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
Current or past diagnosis of recurrent Major Depressive Disorder
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights

tVNS_MDD_Sex Trial Summary

This trial will study the effects of a new treatment, expiratory-gated transcutaneous vagus nerve stimulation (tVNS), on major depressive disorder (MDD). 80 adults with MDD will be randomized to receive either active tVNS or a sham treatment during an fMRI session, while their mood and physiology are assessed. The trial will study whether tVNS can effectively modulate brainstem-cortical pathways of the stress circuitry in a sex-dependent manner, and whether it can attenuate physiological deficits in MDD.

Who is the study for?
This trial is for adults over 50 with a current or past diagnosis of recurrent Major Depressive Disorder. It's not suitable for those with traumatic brain injury, MRI/tVNS contraindications like claustrophobia or metallic implants, history of psychosis, recent severe substance use disorder, significant heart/cerebrovascular disease, CNS diseases (like MS or epilepsy), or pregnant women due to potential risks.Check my eligibility
What is being tested?
The study tests if transcutaneous vagus nerve stimulation (tVNS) can affect stress response in depression differently based on sex. Participants will be randomly assigned to receive either active tVNS or a sham treatment during an fMRI scan while mood and physiological responses are monitored.See study design
What are the potential side effects?
Potential side effects from tVNS may include discomfort at the stimulation site, headache, voice changes due to laryngeal muscle stimulation, shortness of breath if respiratory muscles are affected and possible skin irritation.

tVNS_MDD_Sex Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Major Depressive Disorder more than once.

tVNS_MDD_Sex Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain activity during functional magnetic resonance imaging (fMRI)
Cardiac autonomic function during functional magnetic resonance imaging (fMRI)
Secondary outcome measures
Change in depressive symptoms assessed by the Beck Depression Inventory
Change in serum cortisol levels
Change in serum levels of pro-inflammatory cytokines

tVNS_MDD_Sex Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tVNSExperimental Treatment1 Intervention
Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle
Group II: Sham tVNSPlacebo Group1 Intervention
Sham transcutaneous vagus nerve stimulation on the left auricle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
active tVNS
2019
N/A
~20

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,938 Previous Clinical Trials
13,199,214 Total Patients Enrolled
186 Trials studying Depression
29,613 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,793 Previous Clinical Trials
2,694,308 Total Patients Enrolled
669 Trials studying Depression
253,225 Patients Enrolled for Depression
Ronald G Garcia, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

tVNS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04448327 — N/A
Depression Research Study Groups: Active tVNS, Sham tVNS
Depression Clinical Trial 2023: tVNS Highlights & Side Effects. Trial Name: NCT04448327 — N/A
tVNS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04448327 — N/A

Frequently Asked Questions

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

What are the prerequisites for joining this medical trial?

"80 individuals that have been diagnosed with melancholia, aged between 50 and 65 years old, are eligible to join this research trial. The primary requirement is meeting the criteria of a current or past diagnosis of recurrent Major Depressive Disorder."

Answered by AI

Are geriatric patients being recruited for the trial?

"This research project is only open to individuals aged 50-65. Conversely, 107 trials cater to younger persons and 596 are specifically for seniors."

Answered by AI

How many subjects are being treated as part of this investigation?

"Confirmed. According to clinicaltrials.gov, recruitment is ongoing for this scientific study which was first posted on January 29th 2021 and updated most recently on December 6th 2021. 80 patients are being sought from 1 location."

Answered by AI

Is this research program actively enrolling participants?

"The clinical trial is still in progress, as evidenced by its date of last modification on December 6th 2021. It was initially published to the public on January 29th 2021 per information found on clinicialtrials.gov."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Impact of Transcutaneous Vagal Nerve Stimulation on Stress Response in Major Depression
Ronald Garcia 2021. "Impact of Transcutaneous Vagal Nerve Stimulation on Stress Response in Major Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04448327.
All > Depression Boston
~4 spots leftby Jul 2024
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