Potential Benefit for Non Invasive Vagus Nerve Stimulation Using GammaCore in the Treatment of Raynaud's Phenomena.
Sponsored by University of Toledo Health Science Campus
About this trial
Last updated 5 years ago
Study ID
gammaCore RP
Status
Terminated
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18+ Years
All
Trial Timing
Ended 5 years ago
What is this trial about?
Raynaud's phenomenon (RP) is a common vascular disorder that affects approximately 10% of
the general population. RP is associated with significant morbidity that may include loss
of the digits due to repeated episodes of vasospasm of the digital arteries in addition
to significant impairment of quality of life. It is well known that cold exposure
precipitates episodes of RP, but the mechanism for cold sensitivity is not known, and
treatment of RP is not satisfactory to the patients and their physicians.
The goal in this study is to test the possibility that non invasive vagus nerve
stimulation (nVNS) with gammaCore which is already approved by the FDA for headaches and
migraines may be an effective and well tolerated therapy for Raynaud's Phenomenon.
What are the participation requirements?
Inclusion Criteria
• Clinical Diagnosis of Primary Raynaud's Phenomenon
Exclusion Criteria
- Less than 18 years of age - Pregnant women - Current smokers - Have Digital ulcers - Diagnosed Pulmonary hypertension - Currently on vasodilators (i.e. Phosphodiesterase type 5 inhibitors, prostacyclin, nitroglycerine, or other nitric oxide derivatives) - Currently on Calcium Channel Blockers