NCT03869008

Potential Benefit for Non Invasive Vagus Nerve Stimulation Using GammaCore in the Treatment of Raynaud's Phenomena.

Terminated NA Results posted Last updated 15 July 2025

What this trial tests

NA trial testing gammaCore Sapphire in Raynaud Phenomenon in 6 participants. Terminated before completion.

Timeline

30 April 2019

Primary endpoint
27 February 2020

27 February 2020

Quick facts

Lead sponsor	University of Toledo Health Science Campus
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	6
Start date	30 April 2019
Primary completion	27 February 2020
Estimated completion	27 February 2020
Sites	1 location across United States

Drugs / interventions tested

• gammaCore Sapphire
• Sham Device — full drug profile →

Conditions studied

• Raynaud Phenomenon — all drugs for Raynaud Phenomenon →
• Primary Raynaud Phenomenon — all drugs for Primary Raynaud Phenomenon →
• Raynaud Disease — all drugs for Raynaud Disease →
• Raynaud Syndrome — all drugs for Raynaud Syndrome →

Sponsor

University of Toledo Health Science Campus

Who can join

18 and older, any sex, with Raynaud Phenomenon or Primary Raynaud Phenomenon. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Temperature in 4 Digits Primary · Visit 1 which is Week -4 (Screening) to Visit 2 which is Week 0 (Randomization)

Temperature measured by infrared thermography

baseline right digit visit 1

Group	Value	95% CI
gammaCore	29.48	± 2.43

baseline right digit 2 visit 1

Group	Value	95% CI
gammaCore	28.53	± 4.36

baseline right digit 3 visit 1

Group	Value	95% CI
gammaCore	28.70	± 4.57

baseline right digit 4 visit 1

Group	Value	95% CI
gammaCore	28.88	± 4.49

baseline left digit visit 1

Group	Value	95% CI
gammaCore	29.43	± 1.89

baseline left digit 2 visit 1

Group	Value	95% CI
gammaCore	28.53	± 4.04

baseline left digit 3 visit 1

Group	Value	95% CI
gammaCore	28.15	± 3.87

baseline left digit 4 visit 1

Group	Value	95% CI
gammaCore	28.23	± 3.99

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Control of inflammation using non-invasive neuromodulation: past, present and promise.
   Tynan A, Brines M, Chavan SS. · · 2022 · cited 30× · PMID 34558623 · DOI 10.1093/intimm/dxab073
2. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
   Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124