Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

NCT05517304 | Recruiting FDA Device

• 2 other identifiers: MHBP-004-21FI01CX002331
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans with posttraumatic stress disorder (PTSD). Veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcVNS or sham stimulation at home.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Stress Disorders, Post-Traumatic; PTSD; Vagus Nerve

Outcome Measures

Primary Outcomes (2)

• Change in PTSD symptoms

  Change in PTSD symptoms measured with the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist (PCL) in tcVNS versus sham conditions

  Baseline to three months

• Brain Activation

  Change in brain activation in insula measured with PET in response to trauma scripts with VNS compared to sham

  Baseline

Secondary Outcomes (2)

• Sympathetic function

  Baseline

• Interleukin-6

  Baseline

Study Arms (2)

tcVNS

EXPERIMENTAL

Stimulation twice daily with transcutaneous Vagal Nerve Stimulation (tcVNS)

Device: tcVNS

Sham

ACTIVE COMPARATOR

Stimulation with sham

Device: Sham

Interventions

tcVNS DEVICE

Active stimulation with transcutaneous Vagal Nerve Stimulation (tcVNS)

tcVNS

Sham DEVICE

Sham stimulation

Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans between the ages of 18 and 75 will be included with a diagnosis of PTSD based on DSM-5 criteria

You may not qualify if:

• Subjects will be excluded with:
• a history of mild traumatic brain injury (mTBI) based on VA Criteria
• moderate or greater TBI
• positive pregnancy test
• meningitis or other neurological disorder
• alcohol or substance abuse use disorder based on DSM-5 criteria within the past 12 months
• current or lifetime history of schizophrenia, schizoaffective disorder, bipolar I disorder, anorexia nervosa or bulimia, based on DSM-5
• active suicidal ideation with a plan
• a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness that would preclude participation based on clinical judgment of the PI
• active opiate or benzodiazepine treatment
• history of structural abnormality on brain MRI or CT if one has been performed in the past

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Doug J Bremner, MD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doug J Bremner, MD

CONTACT

(404) 712-9569; James.Bremner@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham stimulation comparison
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: tcVNS versus sham stimulation

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 26, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): July 8, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Three months after study completion
• Access Criteria: Three months after study completion for twelve months

Locations

US (1)