Phase 3 N=56 Randomized Single-blind Other

Closed Loop Vagal Nerve Stimulation for Patients With Posttraumatic Stress Disorder

PostTraumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02992899 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Level of Interleukin-6 (IL6) — 0.88; 0.84; 1.77; 2.11 pg/ml

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: GammaCore/electroCore non-invasive VNS device (Device); Sham gammaCore/electroCore (Device); O-15 water (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Level of Interleukin-6 (IL6)	0.88; 0.84; 1.77; 2.11	—
SECONDARY Level of Tryptophan	50.59; 55.80; 54.42; 57.79	—
SECONDARY Level of Kynurenine	4.72; 7.19; 5.04; 7.06	—
SECONDARY Level of Kynurenic Acid	35.71; 43.07; 38.81; 37.88	—
SECONDARY Level of 3-3 Hydroxykynurenine	—	—
SECONDARY Level of Anthranilic Acid	8.32; 7.02; 7.49; 6.90	—
SECONDARY Level of Tumor Necrosis Factor (TNF)-Alpha	2.81; 2.37; 2.63; 2.26	—
SECONDARY Level of Interferon-Gamma	4.75; 3.43; 4.86; 8.87	—
SECONDARY Level of Interleukin-1 Beta	0.056; 0.086; 0.071; 0.085	—
SECONDARY Level of Interleukin-2 (IL2)	0.29; 0.29; 0.36; 0.27	—
SECONDARY Level of Interleukin-4 (IL4)	—	—
SECONDARY Level of Interleukin-8 (IL8)	—	—
SECONDARY Level of Interleukin-10 (IL10)	—	—
SECONDARY Level of Interleukin-12p70 (IL12p70)	2.20; 3.22; 1.82; 2.96	—
SECONDARY Level of Interleukin-12p (IL12p)	—	—
SECONDARY Level of Interleukin-13 (IL13)	33.77; 43.10; 29.17; 43.55	—
SECONDARY Level of Macrophage Migration Inhibitory Factor	32,204; 31,309; 30,403; 30,515	—
SECONDARY Level of High-Mobility Group Protein B1	1,552; 1,734; 1,299; 1,691	—
SECONDARY Level of Adrenocorticotropic Hormone	—	—
SECONDARY Level of Cortisol	—	—
SECONDARY Level of Epinephrine	—	—
SECONDARY Level of Dopamine	—	—
SECONDARY Level of Norepinephrine	—	—

Summary

The tasks of the project are to map the potency and kinetics of the neurologic, autonomic peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (VNS) vs. sham treatment, at baseline and in response to stressful traumatic scripts related to personal traumatic events, as well as a series of other stressors.

Eligibility Criteria

Inclusion Criteria

Phase 1:

Do not meet criteria for post traumatic stress disorder (PTSD) or other major mental disorder as determined by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5 SCID) interview for PTSD
Have a history of psychological trauma as defined by DSM-5.

Phase 2:

Meet criteria for PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD.

Exclusion Criteria

Positive pregnancy test
Meningitis
Traumatic brain injury
Neurological disorder or organic mental disorder
History of loss of consciousness greater than one minute
Alcohol abuse or substance abuse or dependence based on the SCID within the past 12 months
Positive toxicology screen
Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the SCID
A history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
Evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (complete blood count (CBC), blood urea nitrogen (BUN), creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG)
Active implantable device (i.e. pacemaker)
Carotid atherosclerosis
Cervical vagotomy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02992899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.