Vagus Nerve Stimulation Clinical Trial
Official title:
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Basic Autonomic Nervous System Activity
Verified date | October 2023 |
Source | Bahçesehir University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Transcutaneous Auricular Vagus nerve stimulation may be successful in cardiac modulation because of the cardiac connections of the vagal nerve. Therefore, in order to observe the cardiac effects, it was analysed the changes in pulse rate, systolic and diastolic blood pressure after transcutaneous auricular vagus nerve stimulation application.
Status | Completed |
Enrollment | 72 |
Est. completion date | September 10, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Age between 18 and 40 years old. - No previous vagus nerve stimulation Exclusion Criteria: - Using of any drug, alcohol or smoking. - Pregnancy. - Known history of acute or chronic illness. - Being in the post or peri-menopausal stage. |
Country | Name | City | State |
---|---|---|---|
Turkey | Igdir University | Igdir | Merkez |
Lead Sponsor | Collaborator |
---|---|
Bahçesehir University |
Turkey,
Badran BW, Dowdle LT, Mithoefer OJ, LaBate NT, Coatsworth J, Brown JC, DeVries WH, Austelle CW, McTeague LM, George MS. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Brain Stimul. 2018 May-Jun;11(3):492-500. doi: 10.1016/j.brs.2017.12.009. Epub 2017 Dec 29. — View Citation
Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23. — View Citation
Borovikova LV, Ivanova S, Zhang M, Yang H, Botchkina GI, Watkins LR, Wang H, Abumrad N, Eaton JW, Tracey KJ. Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin. Nature. 2000 May 25;405(6785):458-62. doi: 10.1038/35013070. — View Citation
Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr;236(4):588-611. doi: 10.1111/joa.13122. Epub 2019 Nov 19. — View Citation
Milby AH, Halpern CH, Baltuch GH. Vagus nerve stimulation for epilepsy and depression. Neurotherapeutics. 2008 Jan;5(1):75-85. doi: 10.1016/j.nurt.2007.10.071. — View Citation
Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23. — View Citation
Sclocco R, Garcia RG, Kettner NW, Isenburg K, Fisher HP, Hubbard CS, Ay I, Polimeni JR, Goldstein J, Makris N, Toschi N, Barbieri R, Napadow V. The influence of respiration on brainstem and cardiovagal response to auricular vagus nerve stimulation: A multimodal ultrahigh-field (7T) fMRI study. Brain Stimul. 2019 Jul-Aug;12(4):911-921. doi: 10.1016/j.brs.2019.02.003. Epub 2019 Feb 10. — View Citation
Sigurdsson HP, Raw R, Hunter H, Baker MR, Taylor JP, Rochester L, Yarnall AJ. Noninvasive vagus nerve stimulation in Parkinson's disease: current status and future prospects. Expert Rev Med Devices. 2021 Oct;18(10):971-984. doi: 10.1080/17434440.2021.1969913. Epub 2021 Sep 8. — View Citation
Sinniger V, Pellissier S, Fauvelle F, Trocme C, Hoffmann D, Vercueil L, Cracowski JL, David O, Bonaz B. A 12-month pilot study outcomes of vagus nerve stimulation in Crohn's disease. Neurogastroenterol Motil. 2020 Oct;32(10):e13911. doi: 10.1111/nmo.13911. Epub 2020 Jun 8. — View Citation
Wang Y, Li SY, Wang D, Wu MZ, He JK, Zhang JL, Zhao B, Hou LW, Wang JY, Wang L, Wang YF, Zhang Y, Zhang ZX, Rong PJ. Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application. Neurosci Bull. 2021 Jun;37(6):853-862. doi: 10.1007/s12264-020-00619-y. Epub 2020 Dec 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulse Rate | The pulse rate of the participants was measured with an electronic blood pressure monitor. | Up to 6 Months | |
Primary | Systolic Blood Pressure | The systolic blood pressure of the participants was measured with an electronic blood pressure monitor. | Up to 6 Months | |
Primary | Diastolic Blood Pressure | The diastolic blood pressure of the participants was measured with an electronic blood pressure monitor. | Up to 6 Months |
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