Raynaud PhenomenonNCT03869008
Potential Benefit for Non Invasive Vagus Nerve Stimulation Using GammaCore in the Treatment of Raynaud's Phenomena.
A study testing gammaCore Sapphire in people with Raynaud Phenomenon and Primary Raynaud Phenomenon, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Raynaud Phenomenon, Primary Raynaud Phenomenon, Raynaud Disease
- What is being tested?
- gammaCore Sapphire
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 27 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of Primary Raynaud's Phenomenon
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Toledo Medical Center
Toledo, Ohio, 43614
About this study
Official title: Potential Benefit for Non Invasive Vagus Nerve Stimulation (nVNS) Using GammaCore in the Treatment of Raynaud's Phenomena.
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.
Read the detailed description
Raynaud's phenomenon (RP) is a common vascular disorder that that affects approximately 10% of the general population. RP causes some areas of the body (i.e. fingers and toes) to feel cold and numb in response to cold exposure or emotional stress. Raynaud's phenomenon is characterized by reversible vasospasm of the fingers and toes. This reversible narrowing of the small arteries induces episodes of color changes of the fingers and toes. During an attack of Raynaud's, affected areas of the skin usually first turn white, then they often turn blue and feel cold and numb (pins and needles). As the fingers warm and circulation improves the affected areas may turn red, throb and tingle.
Moreover, Raynaud's phenomenon can be associated with significant morbidity that may include ulceration of fingers and loss of the fingers and toes due to repeated episodes of reversible narrowing of arteries supplying blood to the finger and toes. It is well known that cold exposure leads to 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.
Raynaud's phenomenon is classified as Primary Raynaud's phenomenon (PRP) in the absence of other vascular or connective tissue disease. Raynaud's phenomenon is classified as Secondary Raynaud's phenomenon (SRP) if it is associated with connective tissue disease, like systemic sclerosis (SSc, Scleroderma).
Treatment of Raynaud's phenomenon is not satisfactory in general, as current therapy employing calcium channel blockers and other vasodilators are frequently ineffective or not well tolerated, due to significant side effects.
Noninvasive vagus nerve stimulation (nVNS) is currently FDA approved for therapeutic uses in patient ages 12 and above to treat cluster and migraine headaches. Recent studies have shown that vagal nerve stimulation has vasodilatory and anti-inflammatory properties which has led to more preclinical research examining vagus nerve stimulation as treatment for a wider range of inflammatory and autoimmune disorders. Vagus nerve stimulation has shown promising results in treating chronic inflammatory disorders such as sepsis, lung injury, rheumatoid arthritis, and diabetes. Although there are no direct data to demonstrate vagus nerve stimulation's effect in Raynaud's phenomenon, the investigators believe that VNS's success in treating headache and migraine attacks indirectly support its use in Raynaud's phenomenon by its direct effect on vasospasms (narrowing of blood vessels). In fact migraine has been found as a risk factor for the development of Raynaud's phenomenon further supports this notion.
GammaCore is a safe and effective non-drug treatment approved for treating cluster and migraine headaches. It is a patented device that activates the vagus nerve with gentle electrical stimulation. The vagus nerve is an important highway of communication between the brain and many parts of the body, it plays an important role in regulating pain. Noninvasive vagus nerve stimulation with GammaCore is believed to help block the pain signals that cause migraines and cluster headaches. Unlike traditional vagus nerve stimulation therapies, gammaGore stimulates the vagus nerve through the skin at the side of the neck without the need for surgery. This non-invasive method avoids many side effects and inconveniences associated with injectable, inhaled or pill-based medication.
The investigators' goal is to test the possibility that noninvasive vagus nerve stimulation using gammaCore may be an effective and well tolerated therapy for Raynaud's phenomenon. The investigators aim to gain a fundamental understanding of the role of noninvasive vagus nerve stimulation as a potential therapy for Raynaud's phenomenon, a truly unmet medical need.
- Being tested
- gammaCore Sapphire, Sham Device
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gammaCore SapphireDevice
gammaCore SapphireTM (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore provides a mild electrical stimulation to the vagus nerve, which runs through the neck and carries information to the central nervous system.
Subjects will be instructed to use the gammaCore Sapphire to stimulate 2 minutes on each side of the neck, twice a day, every day. The subject controls the intensity level of the electrical stimulation.
Sham DeviceDevice
The Sham device delivers no electrical stimulations but subjects randomized to the Sham device will received the same instructions to use the Sham device to stimulate 2 minutes on each side of the neck, twice a day, every day for the first 4 weeks after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Sham Device Group | Sham comparator | 15 patients will be randomized to the Sham device for the first half of the treatment window then switch to the gammaCore Sapphire device (study device) for the rest of the study.
The Sham device will look exactly like the gammaCore Sapphire device but will not deliver non invasive vagus nerve stimulation. Receives: Device: gammaCore Sapphire; Device: Sham Device |
| gammaCore Sapphire (Study Device) Group | Experimental | 15 patients will be randomized to the gammaCore Sapphire device for the full length of the treatment window. Receives: Device: gammaCore Sapphire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature in 4 Digits
Temperature measured by infrared thermography
Measured: Visit 1 which is Week -4 (Screening) to Visit 2 which is Week 0 (Randomization)
Secondary outcomes (1)
Condition Scores
The Raynaud's Condition Score is on a scale of 0 to 10 with "0" being no difficulty, "10" being extreme difficulty.
Measured: n/a - No data was collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start30 Apr 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Why it stopped: Funding is no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Raynaud PhenomenonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At randomization subjects are randomized to 2 groups, the Experimental group and the Sham group. The Experimental group will use the study device from randomization to the end of the study. The Sham group will use the Sham device for 4 weeks after randomization then be switched to the study device for the rest of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Collaborators
- ElectroCore INC
- Responsible party
- Principal investigator, Bashar Kahaleh, M.D, University of Toledo Health Science Campus
- Investigators
- Bashar Kahaleh, MD, Principal investigator, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869008
- Sponsor's protocol ID
- gammaCore RP
- Status last verified
- May 2025
- First submitted
- 20 Feb 2019
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Garner R, Kumari R, Lanyon P, Doherty M, Zhang W. Prevalence, risk factors and associations of primary Raynaud's phenomenon: systematic review and meta-analysis of observational studies. BMJ Open. 2015 Mar 16;5(3):e006389. doi: 10.1136/bmjopen-2014-006389.
PubMed 25776043Brand FN, Larson MG, Kannel WB, McGuirk JM. The occurrence of Raynaud's phenomenon in a general population: the Framingham Study. Vasc Med. 1997 Nov;2(4):296-301. doi: 10.1177/1358863X9700200404.
PubMed 9575602Merkel PA, Herlyn K, Martin RW, Anderson JJ, Mayes MD, Bell P, Korn JH, Simms RW, Csuka ME, Medsger TA Jr, Rothfield NF, Ellman MH, Collier DH, Weinstein A, Furst DE, Jimenez SA, White B, Seibold JR, Wigley FM; Scleroderma Clinical Trials Consortium. Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon. Arthritis Rheum. 2002 Sep;46(9):2410-20. doi: 10.1002/art.10486.
PubMed 12355489Matucci-Cerinic M, Kahaleh B, Wigley FM. Review: evidence that systemic sclerosis is a vascular disease. Arthritis Rheum. 2013 Aug;65(8):1953-62. doi: 10.1002/art.37988. No abstract available.
PubMed 23666787Ennis H, Anderson ME, Wilkinson J, Herrick AL. Calcium channel blockers for primary Raynaud's phenomenon. Cochrane Database Syst Rev. 2014 Jan 30;(1):CD002069. doi: 10.1002/14651858.CD002069.pub4.
PubMed 24482037Coleiro B, Marshall SE, Denton CP, Howell K, Blann A, Welsh KI, Black CM. Treatment of Raynaud's phenomenon with the selective serotonin reuptake inhibitor fluoxetine. Rheumatology (Oxford). 2001 Sep;40(9):1038-43. doi: 10.1093/rheumatology/40.9.1038.
PubMed 11561116Pauling JD, Shipley JA, Harris ND, McHugh NJ. Use of infrared thermography as an endpoint in therapeutic trials of Raynaud's phenomenon and systemic sclerosis. Clin Exp Rheumatol. 2012 Mar-Apr;30(2 Suppl 71):S103-15. Epub 2012 May 30.
PubMed 22691218James PB. Cooling patterns in Raynaud's phenomenon and allied peripheral vascular disorders. Br J Surg. 1968 Nov;55(11):860. No abstract available.
PubMed 5686991Zaproudina N, Varmavuo V, Airaksinen O, Narhi M. Reproducibility of infrared thermography measurements in healthy individuals. Physiol Meas. 2008 Apr;29(4):515-24. doi: 10.1088/0967-3334/29/4/007. Epub 2008 Apr 9.
PubMed 18401069Pauling JD, Shipley JA, Raper S, Watson ML, Ward SG, Harris ND, McHugh NJ. Comparison of infrared thermography and laser speckle contrast imaging for the dynamic assessment of digital microvascular function. Microvasc Res. 2012 Mar;83(2):162-7. doi: 10.1016/j.mvr.2011.06.012. Epub 2011 Jul 1.
PubMed 21763703Schlager O, Gschwandtner ME, Herberg K, Frohner T, Schillinger M, Koppensteiner R, Mlekusch W. Correlation of infrared thermography and skin perfusion in Raynaud patients and in healthy controls. Microvasc Res. 2010 Jul;80(1):54-7. doi: 10.1016/j.mvr.2010.01.010. Epub 2010 Feb 6.
PubMed 20144625Johnson RL, Wilson CG. A review of vagus nerve stimulation as a therapeutic intervention. J Inflamm Res. 2018 May 16;11:203-213. doi: 10.2147/JIR.S163248. eCollection 2018.
PubMed 29844694Silberstein SD, Calhoun AH, Treppendahl C, Dodick DW, Rapoport AM, Mamidi A, Vargas P, Ebert TH, Tepper SJ. The emerging role of gammaCore(R) in the management of cluster headache: expert panel recommendations. Am J Manag Care. 2017 Nov;23(17 Suppl):S326-S333.
PubMed 29144718
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Benefit for Non Invasive Vagus Nerve Stimulation (nVNS) Using GammaCore in the Treatment of Raynaud's Phenomena.
- ClinicalTrials.gov ID
- NCT03869008
- Acronym / sponsor ID
- gammaCore RP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding is no longer available
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Collaborators
- ElectroCore INC
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Raynaud's phenomenon (RP) is a common vascular disorder that that affects approximately 10% of the general population. RP causes some areas of the body (i.e. fingers and toes) to feel cold and numb in response to cold exposure or emotional stress. Raynaud's phenomenon is characterized by reversible vasospasm of the fingers and toes. This reversible narrowing of the small arteries induces episodes of color changes of the fingers and toes. During an attack of Raynaud's, affected areas of the skin usually first turn white, then they often turn blue and feel cold and numb (pins and needles). As the fingers warm and circulation improves the affected areas may turn red, throb and tingle.
Moreover, Raynaud's phenomenon can be associated with significant morbidity that may include ulceration of fingers and loss of the fingers and toes due to repeated episodes of reversible narrowing of arteries supplying blood to the finger and toes. It is well known that cold exposure leads to 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.
Raynaud's phenomenon is classified as Primary Raynaud's phenomenon (PRP) in the absence of other vascular or connective tissue disease. Raynaud's phenomenon is classified as Secondary Raynaud's phenomenon (SRP) if it is associated with connective tissue disease, like systemic sclerosis (SSc, Scleroderma).
Treatment of Raynaud's phenomenon is not satisfactory in general, as current therapy employing calcium channel blockers and other vasodilators are frequently ineffective or not well tolerated, due to significant side effects.
Noninvasive vagus nerve stimulation (nVNS) is currently FDA approved for therapeutic uses in patient ages 12 and above to treat cluster and migraine headaches. Recent studies have shown that vagal nerve stimulation has vasodilatory and anti-inflammatory properties which has led to more preclinical research examining vagus nerve stimulation as treatment for a wider range of inflammatory and autoimmune disorders. Vagus nerve stimulation has shown promising results in treating chronic inflammatory disorders such as sepsis, lung injury, rheumatoid arthritis, and diabetes. Although there are no direct data to demonstrate vagus nerve stimulation's effect in Raynaud's phenomenon, the investigators believe that VNS's success in treating headache and migraine attacks indirectly support its use in Raynaud's phenomenon by its direct effect on vasospasms (narrowing of blood vessels). In fact migraine has been found as a risk factor for the development of Raynaud's phenomenon further supports this notion.
GammaCore is a safe and effective non-drug treatment approved for treating cluster and migraine headaches. It is a patented device that activates the vagus nerve with gentle electrical stimulation. The vagus nerve is an important highway of communication between the brain and many parts of the body, it plays an important role in regulating pain. Noninvasive vagus nerve stimulation with GammaCore is believed to help block the pain signals that cause migraines and cluster headaches. Unlike traditional vagus nerve stimulation therapies, gammaGore stimulates the vagus nerve through the skin at the side of the neck without the need for surgery. This non-invasive method avoids many side effects and inconveniences associated with injectable, inhaled or pill-based medication.
The investigators' goal is to test the possibility that noninvasive vagus nerve stimulation using gammaCore may be an effective and well tolerated therapy for Raynaud's phenomenon. The investigators aim to gain a fundamental understanding of the role of noninvasive vagus nerve stimulation as a potential therapy for Raynaud's phenomenon, a truly unmet medical need.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- At randomization subjects are randomized to 2 groups, the Experimental group and the Sham group. The Experimental group will use the study device from randomization to the end of the study. The Sham group will use the Sham device for 4 weeks after randomization then be switched to the study device for the rest of the study.
| Arm | Type | Receives |
|---|---|---|
| Sham Device Group | Sham comparator | Device: gammaCore Sapphire, Device: Sham Device15 patients will be randomized to the Sham device for the first half of the treatment window then switch to the gammaCore Sapphire device (study device) for the rest of the study. The Sham device will look exactly like the gammaCore Sapphire device but will not deliver non invasive vagus nerve stimulation. |
| gammaCore Sapphire (Study Device) Group | Experimental | Device: gammaCore Sapphire15 patients will be randomized to the gammaCore Sapphire device for the full length of the treatment window. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical Diagnosis of Primary Raynaud's Phenomenon
Key exclusion criteria (7 listed)
- Less than 18 years of age
- Pregnant women
- Current smokers
- Have Digital ulcers
- Diagnosed Pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gammaCore SapphiregammaCore SapphireTM (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore provides a mild electrical stimulation to the vagus nerve, which runs through the neck and carries information to the central nervous system. Subjects will be instructed to use the gammaCore Sapphire to stimulate 2 minutes on each side of the neck, twice a day, every day. The subject controls the intensity level of the electrical stimulation. | Device | Sham Device Group, gammaCore Sapphire (Study Device) Group |
| Sham DeviceThe Sham device delivers no electrical stimulations but subjects randomized to the Sham device will received the same instructions to use the Sham device to stimulate 2 minutes on each side of the neck, twice a day, every day for the first 4 weeks after randomization. | Device | Sham Device Group |
Primary outcome
Temperature in 4 Digits
Time frame: Visit 1 which is Week -4 (Screening) to Visit 2 which is Week 0 (Randomization)
Temperature measured by infrared thermography
1 secondary outcome
Condition Scores
Time frame: n/a - No data was collected.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25776043Garner R, Kumari R, Lanyon P, Doherty M, Zhang W. Prevalence, risk factors and associations of primary Raynaud's phenomenon: systematic review and meta-analysis of observational studies. BMJ Open. 2015 Mar 16;5(3):e006389. doi: 10.1136/bmjopen-2014-006389.
- Background: PubMed 9575602Brand FN, Larson MG, Kannel WB, McGuirk JM. The occurrence of Raynaud's phenomenon in a general population: the Framingham Study. Vasc Med. 1997 Nov;2(4):296-301. doi: 10.1177/1358863X9700200404.
- Background: PubMed 12355489Merkel PA, Herlyn K, Martin RW, Anderson JJ, Mayes MD, Bell P, Korn JH, Simms RW, Csuka ME, Medsger TA Jr, Rothfield NF, Ellman MH, Collier DH, Weinstein A, Furst DE, Jimenez SA, White B, Seibold JR, Wigley FM; Scleroderma Clinical Trials Consortium. Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon. Arthritis Rheum. 2002 Sep;46(9):2410-20. doi: 10.1002/art.10486.
- Background: PubMed 23666787Matucci-Cerinic M, Kahaleh B, Wigley FM. Review: evidence that systemic sclerosis is a vascular disease. Arthritis Rheum. 2013 Aug;65(8):1953-62. doi: 10.1002/art.37988. No abstract available.
- Background: PubMed 24482037Ennis H, Anderson ME, Wilkinson J, Herrick AL. Calcium channel blockers for primary Raynaud's phenomenon. Cochrane Database Syst Rev. 2014 Jan 30;(1):CD002069. doi: 10.1002/14651858.CD002069.pub4.
- Background: PubMed 11561116Coleiro B, Marshall SE, Denton CP, Howell K, Blann A, Welsh KI, Black CM. Treatment of Raynaud's phenomenon with the selective serotonin reuptake inhibitor fluoxetine. Rheumatology (Oxford). 2001 Sep;40(9):1038-43. doi: 10.1093/rheumatology/40.9.1038.
- Background: PubMed 22691218Pauling JD, Shipley JA, Harris ND, McHugh NJ. Use of infrared thermography as an endpoint in therapeutic trials of Raynaud's phenomenon and systemic sclerosis. Clin Exp Rheumatol. 2012 Mar-Apr;30(2 Suppl 71):S103-15. Epub 2012 May 30.
- Background: PubMed 5686991James PB. Cooling patterns in Raynaud's phenomenon and allied peripheral vascular disorders. Br J Surg. 1968 Nov;55(11):860. No abstract available.
- Background: PubMed 18401069Zaproudina N, Varmavuo V, Airaksinen O, Narhi M. Reproducibility of infrared thermography measurements in healthy individuals. Physiol Meas. 2008 Apr;29(4):515-24. doi: 10.1088/0967-3334/29/4/007. Epub 2008 Apr 9.
- Background: PubMed 21763703Pauling JD, Shipley JA, Raper S, Watson ML, Ward SG, Harris ND, McHugh NJ. Comparison of infrared thermography and laser speckle contrast imaging for the dynamic assessment of digital microvascular function. Microvasc Res. 2012 Mar;83(2):162-7. doi: 10.1016/j.mvr.2011.06.012. Epub 2011 Jul 1.
- Background: PubMed 20144625Schlager O, Gschwandtner ME, Herberg K, Frohner T, Schillinger M, Koppensteiner R, Mlekusch W. Correlation of infrared thermography and skin perfusion in Raynaud patients and in healthy controls. Microvasc Res. 2010 Jul;80(1):54-7. doi: 10.1016/j.mvr.2010.01.010. Epub 2010 Feb 6.
- Background: PubMed 29844694Johnson RL, Wilson CG. A review of vagus nerve stimulation as a therapeutic intervention. J Inflamm Res. 2018 May 16;11:203-213. doi: 10.2147/JIR.S163248. eCollection 2018.
- Safety information on the gammaCore Sapphire device.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bashar Kahaleh, MD principal investigator
University of Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gammaCore Sapphire in people with Raynaud Phenomenon and Primary Raynaud Phenomenon, run by University of Toledo Health Science Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature in 4 Digits (time frame: Visit 1 which is Week -4 (Screening) to Visit 2 which is Week 0 (Randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869008, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.