Competitive golfers during a 150-yard hitting task.
Device and Treatment Duration
VeRelief first generation prototype 10 minutes of vagus and great auricular nerve stimulation on both sides of neck (bilateral stimulation).
Results
36%
Clinically Significant Reduction (36%) in state-anxiety in active treatment group after single 10-min treatment.
18%
Reductionin state-anxiety in sham group.
Significant improvement in “feel” of each shot in active group alone.
No differences in safety and tolerability between active and sham treatments.
Pain, dizziness, blurred vision, headache, skin itching or irritation.
Significant increase in quality of feel of each shot in active group only.
STUDY THREE
Population
Patients with self-diagnosed Post Traumatic Stress Disorder and Panic Disorder
Device and Treatment Duration
VeRelief handheld device, 5-minutes of self-applied treatment on each side of the neck for a 10-minute totaltreatment time (unilateral stimulation)
Results
24%
Clinically Significant Reduction in State-Anxiety in active treatment group after single treatment
Non-significant improvement in sham group
31%
Active patients found treatment to be relaxing
Increase in Heart Rate Variability in active group alone.
0% change in sham group.
100%
Active patients found treatment to be relaxing
Of Active Users reported treatment to be "Relaxing."
33% of sham participants found treatment to be relaxing
Active participants were 2x more relaxed than sham participants
No differences in safety and tolerability between active and sham treatments.
Pain, dizziness, blurred vision, headache, skin itching or irritation.
CASE STUDY
Population
A 23 year-old-male with severe panic attacks and anxiety
Device and Treatment Duration
Hoolest bilateral and unilateral stimulation device comparison.
Use 2x per day for 8 weeks.
After 8 weeks of using the devices, patient was asked to rate each statement as Strongly Agree, Agree, Neutral, Disagree, or Strongly Disagree.
Results
"I feel better after using the device"
Strongly Agree
63%
of the time.
Agree
37%
of the time.
"The device decreases the severity of my symptoms"
Agree
75%
of the time.
Neutral
25%
of the time.
"I felt better having access to this device in case I have symptoms"
Strongly Agree
25%
of the time.
Agree
75%
Agree
"The Device is easy to use"
Strongly Agree
12.5%
of the time.
Agree
75%
of the time.
"The Device helps me relax"
Strongly Agree
37%
of the time.
Agree
63%
of the time.
Patient Statement:“It has stopped some panic attacks from getting worse and [felt like] I was melting into my bed. Complete mental and physical relaxation.”
VeRelief is Safe
VeRelief and early prototype versions were tested on over 150 people in multiple IRB-approved and sham-controlled clinical studies.
Vagus nerve stimulation was applied to both the left and rightauricular branch of the vagus nerve.
Safety and tolerability was assessed by asking patients to subjectively rate each of the following criteria on a scale of one to 10 for severity immediately after treatment and 24 hours after treatment:
Comfort
Relaxation
Blurred Vision
Dizziness
Discomfort or pain
Headache
Skin Itching or Irritation
No differences in subjective ratings in safety criteria between active and sham groups were found.
VeRelief was designed and built using a Quality Management System compliant to 21 CFR Part 820 required for all medical devices and medical-grade technologies. It was tested, verified, and validated for compliance with rigorous medical device safety standards including:
IEC 60601-1
“Medical electrical equipment –Part 1: General requirements for basic safety and essential performance”
IEC 60601-1-11
“Medical electrical equipment –Part 1-11 General requirements for basic safety and essential performance –Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment”
IEC 60601-1-2
“Medical electrical equipment –Part 1: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances– Requirements and tests”
IEC 60601-2-10, “Medical electrical equipment
“Medical electrical equipment –Particular requirements for the basic safety and essential performance of nerve and muscle stimulators”
VeRelief is now available in limited quantities through our Private Release program. Order yours today and be the first to first to add this powerful new mental health management tool now available to your daily routine.
Order comes with one VeRelief device, a jar of Veragel electrodes for 90-120 days of use, product support materials, and a 60-day money-back guarantee from your date of purchase.
