Vagal Nerve Stimulation in mTBI (VNS mTBI)
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|ClinicalTrials.gov Identifier: NCT04437498|
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : March 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|PTSD mTBI||Device: sham stimulation Device: nVNS||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Veterans are randomized to double blind treatment with active non-invasive Vagal Nerve Stimulation (nVNS) or a sham control.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||code for active and sham devices kept by non study personnel.|
|Official Title:||Non-Invasive Vagal Nerve Stimulation in Veterans With Mild Traumatic Brain Injury (mTBI)|
|Actual Study Start Date :||February 25, 2021|
|Estimated Primary Completion Date :||September 20, 2024|
|Estimated Study Completion Date :||January 15, 2025|
non invasive vagal nerve stimulation
active vns stimulation
Sham Comparator: sham
Device: sham stimulation
non invasive vagal nerve stimulation
- CAPS [ Time Frame: three months ]The Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) is a measure of PTSD symptoms with a range of 0-80 and higher score indicating more severe PTSD symptoms. We will compare change from baseline to post treatment with active vagal nerve stimulation (VNS) or sham stimulation twice daily.
- insula [ Time Frame: 10 minutes ]Blood flow in the insula is measured with positron emission tomography (PET) and radiolabelled water during the performance of stress tasks. We compare blood flow in the insula to whole brain blood flow ratio during stress tasks (listening to personalized traumatic scripts) versus control tasks in the VNS versus sham groups with hypothesis of blocked insula blood flow with VNS
- HVLT-R % retention [ Time Frame: baseline versus three months ]The Hopkins Verbal Learning Test-Revised (HVLT-R) is a test of declarative memory learning that involves the learning of 12 nouns, four from each of three semantic categories, learned over three learning trials, followed 20 minutes later by a delayed free recall trial and recognition trial composed of 24 words with 12 false positives. The percent (%) retention is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3. HLVT-R % retention has a range of 0-100 with 100 being best and 0 worst performance. Baseline and three months post treatment paired with sham or active stimulation are compared.
- Change in IL6 Concentration in Blood with Stress [ Time Frame: Baseline to 120 minutes after stress ]Interleukin-6 (IL6) response to stress paired with active or sham stimulation. IL6 is an inflammatory biomarker measured in blood. We compare IL6 response to stress in VNS versus sham treated groups.
- hippocampal activation [ Time Frame: 10 minutes ]Blood flow in the hippocampus is measured with positron emission tomography (PET) and radiolabelled water during the performance of declarative memory tasks. We compare blood flow in the hippocampus to whole brain blood flow ratio during memory tasks versus control tasks in the VNS versus sham groups with hypothesis of increased hippocampal blood flow with VNS
- PPG amplitude [ Time Frame: Change from baseline to 5 seconds after the termination of stimulation paired with stress ]Photoplethysmography (PPG) amplitude is a measure of peripheral vasoconstriction which is a marker of sympathetic response to stress with active or sham. PPG amplitude is the diameter of the blood vessel in the finger, we measure change from baseline to post active vagal nerve stimulation versus sham stimulation with stress.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437498
|Contact: Doug Bremner, MD||(404) 712-9569||James.Bremner@va.gov|
|Contact: Anna Woodbury, MD||(404) 321-6111 ext 6939||Anna.Woodbury@va.gov|
|United States, Georgia|
|Atlanta VA Medical and Rehab Center, Decatur, GA||Recruiting|
|Decatur, Georgia, United States, 30033|
|Contact: Ashley N Scales 404-321-6111 ext 23952 Ashley.Scales@va.gov|
|Contact: Michael Hart, MD (404) 321-6111 ext 206170 Michael.Hart3@va.gov|
|Principal Investigator: Doug Bremner, MD|
|Principal Investigator:||Doug Bremner, MD||Atlanta VA Medical and Rehab Center, Decatur, GA|