Status:
ACTIVE_NOT_RECRUITING
Impact of Transcutaneous Vagal Nerve Stimulation on Stress Response in Major Depression
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
50-65 years
Phase:
NA
Brief Summary
This study will identify the sex-dependent impact of expiratory-gated transcutaneous vagus nerve stimulation (tVNS) on the modulation of the stress response circuitry and associated physiology in majo...
Detailed Description
Major depressive disorder (MDD) is a leading cause of morbidity and disability worldwide with abnormalities in the stress response circuitry and central autonomic network. Many of these regions are se...
Eligibility Criteria
Inclusion
- Current or past diagnosis of recurrent Major Depressive Disorder
Exclusion
- History of neuroleptic use
- Any psychiatric disorder involving a history of psychosis (e.g. schizophrenia, bipolar I disorder)
- Active suicidal ideation with intent and/or plan or history of a suicide attempt within the last year
- Moderate or severe substance use disorder within the past 12 months
- Diagnosis of significant cardiovascular or cerebrovascular disease (e.g. congestive heart failure, stroke, cardiac conduction disorders, history of asystole or non-sustained ventricular tachycardia)
- Diseases affecting the CNS (e.g. MS, epilepsy, neurodegenerative diseases, etc.)
- Traumatic brain injury with cognitive sequelae
- MRI or tVNS contraindications (e.g. claustrophobia, metallic implants or devices)
- Pregnancy (uncommon, given the age of this cohort is 50+ years) due to unknown health risks for the fetus
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04448327
Start Date
January 29 2021
End Date
May 31 2026
Last Update
December 29 2025
Active Locations (1)
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1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129