Non-invasive VNS Effects on Hyperarousal and Autonomic State in Patients with PTSD
Journal: Frontiers in Medicine (2017) Authors: Damon G. Lamb, Eric C. Porges, Greg F. Lewis and John B. Williamson Background: ...
top of page
Clinical
Research
PILOT TRIAL RESULTS
.jpg)
PTSD
The FDA requires a 50% responder rate and an average 6 pt reduction in the CAPS-5.
​
We are happy to report that the Phoenix exceeded these requirements and provided an average 18.4 pt reduction in CAPS-5, with only 1 non-responder and 1 non-compliant participant. These results were statistically and clinically significant with a p-value of .0100 and a 95%CI: 0.57, 0.98.
qUALITY OF LIFE
The Promis-29 looks at 7 aspects of quality of life and compares responses to the general population to determine severity of responses.
Clinical research
Why Research VNS?
The vagus nerve is the key component of the parasympathetic branch of the autonomic nervous system, the sympathetic and parasympathetic nervous systems act reciprocally. The vagus nerve is critical in many therapeutic areas due to its beneficial effect in restoring balance in cases where sympathetic activity is abnormally raised or parasympathetic activity is lowered.
Researchers are investigating: VNS mechanisms of action, restoration of autonomic balance, laying new neural pathways during tasks, reduction of symptoms and systemic imflammatory responses and much more...
Phoenix CR Trials
We are looking for medical clinics, hospitals and research facilities to conduct IRB supported clinical trials for the Phoenix CR device.
​
If you are interested in participating and have a PTSD specific protocol, please contact us. We will work with you throughout the entire process to assure that you and your clients are getting the support and care needed for success.
We appreciate all the clinics assisting in this stage of Phoenix CR's FDA approval process. We look forward to the day that we can make this life changing medical device available to the public.
Evren taVNS Research Areas
-
Traumatic Brain Injury
-
PTSD
-
Anxiety
-
Depression
-
Sleep Disruption
-
Adjustment Disorders
-
Fear
-
Cognition and Learning
-
Tinnitus
Phoenix CR
taVNS Research Device
The Phoenix® CR is designed specifically to produce high-quality transcutaneous auricular vagus nerve stimulation (taVNS) data from human clinical trials
This product has not been evaluated by the Food and Drug Administration and is not intended to diagnose, treat, cure or prevent any disease or medical condition. This device is not available for commercial sale in the United States. It is an investigational device limited by law to use under IRB protocol.
Easy-to-use & Portable
-
No hands needed during stimulation sessions
-
Use the CR device with minimal interruption to your daily life
-
Only charge once per week!
Fully programmable
-
Design & save custom programs
-
Adjust stimulation parameters
-
Choose stimulation ports
-
Select when to calibrate
-
Measure impedence
-
Track adherence
-
Download data
​
Impedance Monitoring
-
Monitors resistance to stimulation in real time
-
Ensures proper device usage and optimal stimulation as defined in clinical protocol
CR Device
Soft, Conforming Earpiece
-
Made of soft silicone.
-
Available in 3 sizes:
-
Small, Medium and Large
-
-
Programmable
-
Time
-
Intensity
-
Sham
-
-
Track usage & adherence
-
Long battery life
Clinical Research
support
-
Assist with protocol development
-
Full training and installation
-
Clinical support
-
IT support for data collection, download and interpretation
-
Repair, maintenance and replacement
“It’s not a drug that I’m putting in my system and its not something that I’m smoking. So, if you’re telling me that you can put something in my ear and make me better, sign me up every day of the week!”
- Andy, from Evren's PTSD Pilot Study
bottom of page