19 completed, 7 terminated, 4 withdrawn, 2 recruiting. 29 Not applicable, 1 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 29 | Completed 17, Terminated 6, Withdrawn 4, Recruiting 2 |
| Phase 1 | 1 | Completed 1 |
| Phase 2 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD) non-invasive vagus nerve stimulation - PTSD, Post Traumatic Stress Disorder PTSD | Not applicable | Recruiting | Acacia Clinics | 40 | 2026-03-02 | 2026-10-08 |
| Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage gammaCore - Subarachnoid Hemorrhage, Aneurysmal | Not applicable | Recruiting | Massachusetts General Hospital | 25 | 2022-10-04 | 2026-05-14 |
| Non-invasive Vagus Nerve Stimulation in the Treatment of Crohn's Disease - A Pilot Study Vagal Nerve Stimulator - Crohn Disease | Not applicable | Terminated | Indiana University | 4 | 2021-11-30 | 2025-03-06 |
| Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress nVNS, SOC - Acute Respiratory Distress Syndrome, Acute Lung Injury | Not applicable | Completed | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | 3 | 2021-08-04 | 2026-05-29 |
| Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients With Gastroparesis and Related Disorders nVNS (gammaCore) - Chronic Unexplained Nausea and Vomiting, Gastroparesis | Not applicable | Completed | Johns Hopkins University | 49 | 2021-04-19 | 2024-10-15 |
| Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms gammaCore® Sapphire (non-invasive vagus nerve stimulator), Standard of care therapies - COVID, Corona Virus Infection | Not applicable | Terminated | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | 21 | 2020-05-15 | 2024-05-01 |
| Treatment of Complications to Diabetic Autonomic Neuropathy With Vagus Nerve Stimulation Non-invasive transcutaneous vagus nerve stimulation, Sham vagus nerve stimulation - Gastrointestinal Dysfunction, Diabetes Mellitus | Not applicable | Completed | Aalborg University Hospital | 120 | 2020-01-20 | 2023-06-07 |
| Study of Gammacore Sapphire for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH) gammaCore Sapphire, sham gammaCore Sapphire - Post-Traumatic Headache | Not applicable | Withdrawn | University of Texas Southwestern Medical Center | 2020-01-01 | 2020-03-10 | |
| Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke non-invasive Vagus Nerve Stimulator - Ischemic Stroke | Not applicable | Completed | Leiden University Medical Center | 150 | 2019-10-09 | 2025-05-14 |
| A Randomized, Multicenter, Study for the prEvention and Acute Treatment of Migraine (REAL) non-invasive vagus nerve stimulation - Migraine | Not applicable | Withdrawn | ElectroCore INC | 2019-05-15 | 2019-06-14 | |
| Non-invasive TRanscutaneous Cervical Vagus Nerve Stimulation as a Treatment for Acute Stroke; Safety and Feasibility Study Gammacore device, Gammacore sham device - Stroke, Acute, Stroke, Ischemic | Not applicable | Completed | Turkish Stroke Research and Clinical Trials Network | 69 | 2019-05-10 | 2021-10-05 |
| Potential Benefit for Non Invasive Vagus Nerve Stimulation Using GammaCore in the Treatment of Raynaud's Phenomena. gammaCore Sapphire, Sham Device - Raynaud Phenomenon, Primary Raynaud Phenomenon | Not applicable | Terminated | University of Toledo Health Science Campus | 6 | 2019-04-30 | 2025-07-15 |
| Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines gammaCore Sapphire active, gammaCore Sapphire Sham - Migraine Disorders | Not applicable | Completed | ElectroCore INC | 231 | 2018-11-02 | 2020-09-11 |
| Neuromodulation in Patients With Painful Chronic Pancreatitis GammaCore Device, Sham Device - Painful Chronic Pancreatitis, Visceral Pain | Not applicable | Completed | Jens Brøndum Frøkjær | 28 | 2018-01-11 | 2022-02-17 |
| Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury gammaCore active device, gammaCore sham device - Traumatic Brain Injury, Acute Brain Injuries | Phase 1 | Completed | CentraCare | 14 | 2016-10-01 | 2021-02-04 |
| RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks gammaCore-S, gammaCore-S Sham - Migraine | Not applicable | Completed | ElectroCore INC | 285 | 2016-01-01 | 2019-08-02 |
| A Randomized, Sham-controlled Study of gammaCore ® (nVNS) for Prevention of Episodic Migraine gammaCore®-R, gammaCore®-R Sham - Migraine | Not applicable | Completed | ElectroCore INC | 477 | 2015-06-01 | 2019-08-19 |
| A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G gammaCore®-G - Dyspepsia, Irritable Bowel Syndrome | Not applicable | Completed | ElectroCore INC | 91 | 2014-06-01 | 2018-03-07 |
| A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache. gammaCore - Cluster Headache | Not applicable | Completed | ElectroCore INC | 102 | 2013-08-01 | 2019-02-26 |
| Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy gammaCore - Seizure | Not applicable | Terminated | ElectroCore INC | 13 | 2013-07-01 | 2019-04-23 |
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Migraine Disorders (7) · Asthma (4) · Cluster Headache (3) · Brain Injuries, Traumatic (2) · Bronchiolitis Obliterans Syndrome (2) · Ischemic Stroke (2) · Pulmonary Disease, Chronic Obstructive (2) · Respiratory Distress Syndrome (2) · Acute Lung Injury (1) · Aneurysm (1) · Aneurysm, Ruptured (1) · Brain Diseases (1) · Brain Infarction (1) · Brain Injuries (1) · Brain Ischemia (1)
United States (16) · Denmark (5) · Germany (5) · United Kingdom (5) · Italy (3) · Netherlands (3) · Belgium (2) · Spain (2) · Australia (1) · Canada (1) · Greece (1) · Norway (1) · South Africa (1) · Turkey (Türkiye) (1)
Alexandra Sinclair, MD (1) · Aman B Patel, MD (1) · Bashar Kahaleh, MD (1) · Boyle Cheng, PhD (1) · Brian Rowe, M.D. (1) · Charly Gaul, Dr med (1) · Cristina Tassorelli, MD, PhD (1) · Dale Cilliers (1) · David Walega, MD (1) · Elmin Steyn, MD (1) · Ethem M Arsava, MD (1) · Hakan Ay, MD (1) · Hans-Christoph Diener, Professor (1) · JP Errico (1)
PMID 31246132, PMID 23510361, PMID 24607501, PMID 27102120, PMID 27412146, PMID 27593728, PMID 29907608, PMID 30340460, PMID 30382909, PMID 31522546, PMID 31603076, PMID 33106174, PMID 33408197, PMID 33635894, PMID 35001643, PMID 36356829, PMID 38546822, PMID 41100038