Raynaud Phenomenon Clinical Trial
Official title:
Potential Benefit for Non Invasive Vagus Nerve Stimulation (nVNS) Using GammaCore in the Treatment of Raynaud's Phenomena.
Verified date | November 2020 |
Source | University of Toledo Health Science Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | October 16, 2020 |
Est. primary completion date | October 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Unversity of Toledo Medical Center | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Toledo Health Science Campus | ElectroCore INC |
United States,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Response rates | Observe response rates in an open label fashion after subjects randomized to the sham device are transitioned to the gammaCore nVNS device. | 12 weeks | |
Primary | Evaluate the clinical efficacy of the gammaCore nVNS device at preventing vasospasms, thus reducing the number of and duration of Raynaud's attacks in patients with Primary Raynaud's Phenomenon. | Evaluate the clinical efficacy of gammaCore (15 patients) vs sham device (15 patients) in preventing vasospasms in 30 PRP patients.
The clinical efficacy of the nVNS device will be accessed through subject reported outcomes by way of the diary that will be handed out to subjects for the duration of the study, both before and after subjects have started using the gammaCore device. The diary will track daily the number of attacks of Raynaud's phenomenon and the duration of these attacks each day. The combination of the number of RP attacks and their duration will be used to evaluate the efficacy of the nVNS device at preventing vasospasms by analyzing changes in frequency and duration of RP attacks in subjects before and after they have started using the gammaCore device. |
12 weeks | |
Secondary | Evaluate improvements in Raynaud's condition scores after using the gammaCore nVNS device. | Evaluate the clinical efficacy of gammaCore (15 patients) vs sham device (15 patients) on Raynaud's symptoms and chronic PRP in 30 patients for four weeks using Raynaud's condition score.
The Raynaud's Condition Score is presented in the diary that will be handed out to subjects for the duration of the study. The Raynaud's Condition Score will ask subjects from a scale of 0 to 10, "0" being no difficulty, "10" being extreme difficulty, the number that best indicates the difficulty the subjects had each day with Raynaud's condition. The Raynaud's Condition Score is for subjects to rate how much difficulty the subjects had with Raynaud's each day by considering how much pain, numbness or other symptoms the Raynaud's caused in subjects' fingers and how much Raynaud's alone affected the use of the subjects' hands each day |
12 weeks |
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