Closed Loop Vagal Nerve Stimulation for Patients With Posttraumatic Stress Disorder

• Status: Completed
• Trial end date: 2019-09-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Georgia Institute of Technology

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