Clinical Trials Logo
  1. Home
  2. Stress Disorders, Post-Traumatic
  3. NCT05212714

taVNS to Reduce PTSD Symptoms in WTC Responders — taVNS  

Stress Disorders, Post-Traumatic Clinical Trial

Official title:
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) to Reduce Post Traumatic Stress Disorder (PTSD) Symptoms in World Trade Center (WTC) Responders

Clinical Trial Summary

This study seeks to conduct a randomized, double-blind pilot study, to determine whether the Transcutaneous Auricular Vagus Nerve Stimulation and study procedure are feasible and acceptable for use with World Trade Center responders with Post Traumatic Stress Disorder.

Clinical Trial Description

Participants will be randomized to one of two groups; one that receives stimulation and one that does not. Once their device is ready (roughly 1 month), they will be asked to participate in a baseline questionnaire. They will also be given a phone to interface with the device and record their usage and will use the device for one 15-minute session under the supervision of members of the research team and be monitored using a combination of non-invasive equipment, including an brain activity monitoring cap, blood pressure cuff (to monitor blood pressure), a respiratory belt (to monitor respirations) and an eye tracking device (to monitor eye movement). Researchers are using these tests to see if there are any inflammatory, neural, and cardiovascular changes that relate to the treatment. A research nurse will collect 12 mL of blood (roughly 2 tsp) before and after their session. Blood will be drawn to look at markers of inflammation before using the device, after using the device, and again at the 6-week follow-up visit. They will then be asked to complete a survey regarding the stimulation device on an iPad. After their initial visit, they will be instructed to use the device twice a day, every day at home, for 15 minutes over 8 weeks. After 8 weeks, they will be asked to come in for a final visit, where they will be asked to complete another 15-minute device session, blood draw and survey regarding their experiences. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05212714
Study type Interventional
Source Northwell Health
Contact
Status Completed
Phase N/A
Start date March 31, 2022
Completion date February 15, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05620381 - Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018
Completed NCT02856412 - Improving Mind/Body Health and Functioning With Integrative Exercise N/A
Recruiting NCT05400200 - PTSD and Self-regulation: Coping, Emotional Regulation and Cognitive Control and Their Relationships to Symptom Management N/A
Not yet recruiting NCT06088303 - Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication N/A
Not yet recruiting NCT03652922 - Propranolol Reactivation Mismatch (PRM) Treatment for PTSD Phase 4
Completed NCT02875912 - Prospective Evaluation of Family Care Rituals in the ICU N/A
Completed NCT01589575 - Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives N/A
Completed NCT01291368 - Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care N/A
Completed NCT00990106 - Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD) N/A
Active, not recruiting NCT00657787 - Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans
Completed NCT00880152 - Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study N/A
Completed NCT00835627 - Treatment Trial for Psychogenic Nonepileptic Seizures Phase 4
Completed NCT01365247 - Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00419029 - Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment N/A
Completed NCT00514956 - Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT00333710 - Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD N/A
Completed NCT01120847 - Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
Completed NCT00069225 - Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder N/A
Completed NCT00055354 - Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00186212 - Alternative Support for Rural and Isolated Women in an HMO Phase 3