Publication Library

gammaCore™ non-invasive vagus nerve stimulator (nVNS) was granted Breakthrough Device Designation for PTSD by the US Food and Drug Administration in January 2022.

Publications:

1. Schindler AG, Meabon JS, Baskin B, et al. Non-invasive vagus nerve stimulation for the prevention/treatment of comorbid mild traumatic brain injury and PTSD. Poster presented at: 3rd International Brain Stimulation Conference; February 24-27, 2019; Vancouver, BC, Canada.
2. Bremner JD, et al. Transcutaneous Cervical Vagal Nerve Stimulation in Patients with Posttraumatic Stress Disorder (PTSD): A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 Response to Stress. J Affect Disord Rep. 2021 Dec;6:100190. doi: 10.1016/j.jadr.2021.100190. Epub 2021 Jul 10. PMID: 34778863; PMCID: PMC8580056
3. Gurel NZ, et al. Transcutaneous cervical vagal nerve stimulation reduces sympathetic responses to stress in posttraumatic stress disorder: A double-blind, randomized, sham controlled trial. Neurobiol Stress. 2020 Oct 20;13:100264. doi: 10.1016/j.ynstr.2020.100264. PMID: 33344717; PMCID: PMC7739181.
4. Gazi AH, et al. Transcutaneous Cervical Vagus Nerve Stimulation Inhibits the Reciprocal of the Pulse Transit Time's Responses to Traumatic Stress in Posttraumatic Stress Disorder. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:1444-1447. doi: 10.1109/EMBC46164.2021.9630415. PMID: 34891557; PMCID: PMC10114282.
5. Choudhary T, et al. Effect of transcutaneous cervical vagus nerve stimulation on declarative and working memory in patients with Posttraumatic Stress Disorder (PTSD): A pilot study. J Affect Disord. 2023 Oct 15;339:418-425. doi: 10.1016/j.jad.2023.07.025. Epub 2023 Jul 12. PMID: 37442455.
6. Gurel NZ, et al. Effect of transcutaneous cervical vagus nerve stimulation on the pituitary adenylate cyclase-activating polypeptide (PACAP) response to stress: A randomized, sham controlled, double blind pilot study. Compr Psychoneuroendocrinol. 2020 Oct 27;4:100012. doi: 10.1016/j.cpnec.2020.100012. PMID: 35755625; PMCID: PMC9216713.
7. Gurel NZ, et al. Quantifying acute physiological biomarkers of transcutaneous cervical vagal nerve stimulation in the context of psychological stress. Brain Stimul. 2020;13(1):47-59. doi:10.1016/j.brs.2019.08.002.
8. Wittbrodt MT, et al. Non-invasive vagal nerve stimulation decreases brain activity during trauma scripts. Brain Stimul. 2020 Sep-Oct;13(5):1333-1348. doi: 10.1016/j.brs.2020.07.002. Epub 2020 Jul 10. PMID: 32659483; PMCID: PMC8214872
9. Wittbrodt, Matthew T. et al. Noninvasive Cervical Vaga l Nerve Stimulation Alters Brain Activity During Traumatic Stress in Individuals With Posttraumatic Stress Disorder. Psychosomatic Medicine 83(9):p 969-977, 11/12 2021. | DOI: 10.1097/PSY.0000000000000987
10. Moazzami K. et al, Transcutaneous vagal nerve stimulation modulates stress-induced plasma ghrelin levels: A double-blind, randomized, sham-controlled trial, Journal of Affective Disorders, Volume 342, 2023, Pages 85-90, ISSN 0165-0327, https://doi.org/10.1016/j.jad.2023.09.015.

gammaCore™ non-invasive vagus nerve stimulator (nVNS) has not been approved by FDA for use in Opioid Use Disorder (OUD) and the safety and effectiveness of gammaCore for OUD has not been established.

Publications:

1. Gazi, A. H., Harrison, A. B., Lambert, T. P., Nawar, A., Obideen, M., Driggers, E. G., ... & Bremner, J. D. (2022). Pain is reduced by transcutaneous cervical vagus nerve stimulation and correlated with cardiorespiratory variability measures in the context of opioid withdrawal. Frontiers in Pain Research, 3, 1031368. https://www.frontiersin.org/journals/pain-research/articles/10.3389/fpain.2022.1031368/full
2. Klaming, R., Harlé, K.M, Lerman, I., Fong C., Hu, R., Norman, S. B., Simmons, A. N., Spadoni, A. D., & Lerman, I. (2024). NONINVASIVE VAGAL NERVE STIMULATION AS NOVEL TREATMENT FOR ALCOHOL USE DISORDER – INITIAL EVIDENCE FOR SYMPTOM REDUCTION AND ALTERED NEURAL RESPONSE TO PAIN. Presented at the Research Society on Alcoholism Annual Meeting, Minneapolis, MN, USA. June 22, 2024. https://onlinelibrary.wiley.com/doi/10.1111/acer.15318
3. Gazi, A. H., Harrison, A. B., Lambert, T. P., Obideen, M., Alavi, P., Murrah, N., ... & Bremner, J. D. (2022). Transcutaneous cervical vagus nerve stimulation reduces behavioral and physiological manifestations of withdrawal in patients with opioid use disorder: a double-blind, randomized, sham-controlled pilot study. Brain stimulation, 15(5), 1206-1214. https://www.sciencedirect.com/science/article/pii/S1935861X22001954

gammaCore™ non-invasive vagus nerve stimulator (nVNS) has not been approved by the FDA for use in the treatment of gastrointestinal diseases, and the safety and effectiveness of gammaCore for gastrointestinal diseases has not been established.

Publications:

1. Paulon E, Nastou D, Jaboli F, Marin J, Liebler E, Epstein O. Proof of concept: short-term non-invasive cervical vagus nerve stimulation in patients with drug-refractory gastroparesis. Frontline Gastroenterol. 2017 Oct;8(4):325-330. doi: 10.1136/flgastro-2017-100809. Epub 2017 May 24. PMID: 29067158; PMCID: PMC5641854.
2. Gottfried-Blackmore A, Adler EP, Fernandez-Becker N, Clarke J, Habtezion A, Nguyen L. Open-label pilot study: non-invasive vagal nerve stimulation improves symptoms and gastric emptying in patients with idiopathic gastroparesis. Neurogastroenterol Motil. 2020;32(4):e13769. doi:10.1111/nmo.13769
3. Chapman, Stephen J., et al. "Non-invasive, vagus nerve stimulation to reduce ileus after colorectal surgery: protocol for a feasibility trial with nested mechanistic studies." BMJ open 11.7 (2021): e046313.
4. Barahona, Guillermo, et al. "S1846 Non-Invasive Vagal Nerve Stimulation Reduces Nausea Rescue Medication in Patients With Gastroparesis and Related Disorders, With Additional Benefits on Multiple Other Associated Symptoms." Official journal of the American College of Gastroenterology| ACG 118.10S (2023): S1373.
5. Gottfried-Blackmore, Andres, Aida Habtezion, and Linda Nguyen. "Noninvasive vagal nerve stimulation for gastroenterology pain disorders." Pain Management 11.1 (2021): 89-96.

gammaCore™ non-invasive vagus nerve stimulator (nVNS) has not been approved by the FDA for use in the treatment of Parkinson's Disease, and the safety and effectiveness of gammaCore for Parkinson's Disease has not been established.

Publications:

1. Sigurdsson, Hilmar P., et al. "Noninvasive vagus nerve stimulation in Parkinson’s disease: current status and future prospects." Expert Review of Medical Devices 18.10 (2021): 971-984.
2. Mondal, Banashree, et al. "Effects of non-invasive vagus nerve stimulation on clinical symptoms and molecular biomarkers in Parkinson’s disease." Frontiers in Aging Neuroscience 15 (2024): 1331575.
3. Torrecillos, Flavie, et al. "Non-invasive vagus nerve stimulation modulates subthalamic beta activity in Parkinson's disease." Brain Stimulation: Basic, Translational, and Clinical Research in Neuromodulation 15.6 (2022): 1513-1516.

gammaCore™ non-invasive vagus nerve stimulator (nVNS) has not been approved by the FDA for use in the treatment of brain injury, and the safety and effectiveness of gammaCore for brain injury has not been established.

Publications:

1. Arsava, Ethem Murat, et al. "Assessment of safety and feasibility of non-invasive vagus nerve stimulation for treatment of acute stroke." Brain stimulation 15.6 (2022): 1467-1474.
2. van der Meij, Anne, et al. "NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial." Trials 21 (2020): 1-6.
3. Andalib, Sasan, et al. "Vagus Nerve Stimulation in Ischemic Stroke." Current neurology and neuroscience reports 23.12 (2023): 947-962.
4. Lindemann, Jan, et al. "Vagus nerve stimulation reduces spreading depolarization burden and cortical infarct volume in a rat model of stroke." PLoS One 15.7 (2020): e0236444.
5. Ay, Ilknur, Eric Liebler, and Hakan Ay. "Effect of non-invasive vagus nerve stimulation in hemorrhagic brain injury and permanent ischemic stroke in rats (P10-10.005)." Neurology 98.18_supplement (2022): 1758.
6. Ay, Ilknur, et al. "Transcutaneous cervical vagus nerve stimulation ameliorates acute ischemic injury in rats." Brain stimulation 9.2 (2016): 166-173.
7. Ayata, Cenk, et al. "Suppression of cortical spreading depression in migraine prophylaxis." Annals of Neurology: Official Journal of the American Neurological Association and the Child Neurology Society 59.4 (2006): 652-661.
8. Morais, A., Liu, T. T., Qin, T., Sadhegian, H., Ay, I., Yagmur, D., ... & Ayata, C. (2020). Vagus nerve stimulation inhibits cortical spreading depression exclusively through central mechanisms. Pain, 161(7), 1661-1669.
9. Liu, Tzu-Ting, et al. "Efficacy profile of noninvasive vagus nerve stimulation on cortical spreading depression susceptibility and the tissue response in a rat model." The Journal of Headache and Pain 23.1 (2022): 12.
10. Chen, S. P., Ay, I., De Morais, A. L., Qin, T., Zheng, Y., Sadeghian, H., ... & Ayata, C. (2016). Vagus nerve stimulation inhibits cortical spreading depression. Pain, 157(4), 797-805.
11. Yang, L. Y., Bhaskar, K., Thompson, J., Duval, K., Torbey, M., & Yang, Y. (2022). Non-invasive vagus nerve stimulation reduced neuron-derived IL-1β and neuroinflammation in acute ischemic rat brain. Brain Hemorrhages, 3(2), 45-56.
12. Morais, A., Chung, J. Y., Wu, L., Ayata, C., Simon, B., & Whalen, M. J. (2024). Non-Invasive Vagal Nerve Stimulation Pre-Treatment Reduces Neurological Dysfunction After Closed Head Injury in Mice. Neurotrauma Reports, 5(1), 150-158.
13. Yang, Yirong, et al. "Non-invasive vagus nerve stimulation reduces blood-brain barrier disruption in a rat model of ischemic stroke." Brain stimulation 11.4 (2018): 689-698.
14. Divani, A. A., Salazar, P., Ikram, H. A., Taylor, E., Wilson, C. M., Yang, Y., ... & Bragin, D. E. (2023). Non-invasive Vagus nerve stimulation improves brain lesion volume and neurobehavioral outcomes in a rat model of traumatic brain injury. Journal of neurotrauma, 40(13-14), 1481-1494.
15. Divani, A. A., Taylor, E., Ikram, H. A., Salazar, P., Yang, Y., SantaCruz, K., ... & Bragin, D. E. (2022). Noninvasive Vagus Nerve Stimulation Reduces Brain Lesion Volume in a Rat model of Traumatic Brain Injury.