Status:
COMPLETED
Vagal Nerve Stimulation to Probe Inflammation and Brain in Post-traumatic Stress
Lead Sponsor:
VA Office of Research and Development
Conditions:
Post-traumatic Stress
Eligibility:
MALE
21-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The proposal aims to determine if non-invasive vagus nerve stimulation(nVNS) will alter: 1) the peripheral inflammatory biomarker profile, 2) the neural correlates of change in pain stimuli and 3) PTS...
Detailed Description
Rates of posttraumatic stress disorder (PTSD) are high among combat Veterans with estimates of PTSD within Iraq and Afghanistan Veterans at nearly 17% of active duty and over 24% of reserve service me...
Eligibility Criteria
Inclusion
- Male subjects between 21 and 65 years, any race or ethnicity.
- For PTSD: Previously deployed, experienced a traumatic event, and meets Clinician-Administered PTSD Scale for DSM-5(CAPS-5) symptom cluster severity criteria for PTSD diagnosis, as well as CAPS total cut-off score \> 33. 3. For CC: Previously deployed, experienced a traumatic event, and fails to meet CAPS-5 symptom cluster severity criteria for PTSD diagnosis with CAPS total cut-off score \< 20.
- Capable of complying with study schedule, procedures, and speaks English.
- Able to provide voluntary written informed consent prior to initiation of Visit 1; and be able to commit to the return visit at the end of the study.
Exclusion
- Rule out significant mental illness, e.g. psychosis, bipolar disorder as well as major depression pre-dating PTSD, based on Structured Clinical Interview for DSM-5(SCID) interview.
- At risk for suicide or homicide(based upon Columbia Suicide Risk Severity Scale(C-SSRS) or BDI-2 screen and follow-up clinical interview).
- Any subject who has undergone evidence-based treatment(CPT or PE) within one month prior to study enrollment or plans to undergo CPT or PE during the study.
- History of head trauma involving loss of consciousness\>1 minute and post-concussive symptoms(PCS).
- Chronic pain as defined by pain persisting beyond its ecological alerting function, and clinically defined as lasting longer than 3 months, and/or currently under the care of a chronic pain physician.
- Any condition or therapy that, in the opinion of the investigator and research team, may be significantly worsened by the administration of study treatment or is likely to interfere with the successful collection of the measures required.
- Clinically significant uncontrolled/unstable medical illness or clinically significant surgery within 1 month of the screening visit.
- Evidence of a maladaptive pattern of alcohol use or abuse(based on AUDIT-C interview) one month prior to the screening visit and or illicit drug use or abuse as measured by urine screen positive for illicit substances at the screening Visit 1 or follow up Visit 2.
- Participation in a pharmaceutical trial or exposure to investigational drugs within 1 month of the screening visit.
- Standard of care medications used to treat PTSD will be continued. Any subject that takes anti-inflammatory medications for chronic medical conditions or takes other medications for chronic pain will be excluded.
- MRI-related exclusion criteria: A cardiac pacemaker; metal fragments in eyes/skin/body(shrapnel), subjects who have ever been metal workers/welders; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, bypass surgery/coronary artery clips, hearing aid, heart-valve replacement, subjects with an intrauterine device, a shunt(ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators; vision problems uncorrectable with lenses; claustrophobia; inability to lie still on their backs for approximately 60 minutes; prior neurosurgery; or unwillingness or inability to remove nose, ear, tongue, or face rings. Any implants will be reviewed for safety.
- Vagus nerve stimulation related criteria: history of carotid endarterectomy, severe carotid artery disease\[e.g. bruits on physical exam or history of transient ischemic attack(TIA) or stroke\], congestive heart failure(CHF), cardiac arrhythmia, known severe coronary artery disease or recent myocardial infarction(within 5 years), or a history or seizure or syncope(within the last 1 year), or prior neck surgery will be excluded.
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03858985
Start Date
February 4 2019
End Date
March 31 2025
Last Update
April 10 2025
Active Locations (1)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002