Phase 3
Completed N=56
Closed Loop Vagal Nerve Stimulation for Patients With Posttraumatic Stress Disorder
Source: ClinicalTrials.gov NCT02992899 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Level of Interleukin-6 (IL6) — 0.88; 0.84; 1.77; 2.11 pg/ml
◆ Published Evidence
Established
74citations · ~12 / year
Transcutaneous cervical vagal nerve stimulation reduces sympathetic responses to stress in posttraumatic stress disorder: A double-blind, randomized, sham controlled trial.
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.
Linked Publications (3)
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Transcutaneous cervical vagal nerve stimulation reduces sympathetic responses to stress in posttraumatic stress disorder: A double-blind, randomized, sham controlled trial.
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Digital Cardiovascular Biomarker Responses to Transcutaneous Cervical Vagus Nerve Stimulation: State-Space Modeling, Prediction, and Simulation.
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Noninvasive Cervical Vagal Nerve Stimulation Alters Brain Activity During Traumatic Stress in Individuals With Posttraumatic Stress Disorder.
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 |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02992899) and the linked publication. 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. Informational only — not medical advice.