tVNS for Depression | NCT02562703 | Trialant

tVNS for Depression | NCT02562703 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACTIVE tVNS	Active Comparator	tVNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed over the mastoid process bilaterally. The study protocol will follow the rational of our previous trials with TNS.	Device: Transcutaneous Vagus Nerve Stimulation
SHAM tVNS	Sham Comparator	tVNS will be applied by the external simulator (Monarch). The stimulation will be turned off after 60 seconds following previous trials.	Device: Transcutaneous Vagus Nerve Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcutaneous Vagus Nerve Stimulation	Device	tVNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed over the mastoid process bilaterally. The study protocol will follow the rational of our previous trials with TNS.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• Hamilton Depressive Rating Scale version 17 items (HDRS-17)	This clinical trial has as primary objective to evaluate the effect of the tVNS on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.	Change from baseline in depressive symptoms at 2 weeks

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26358492	Result	Trevizol AP, Sato IA, Bonadia B, Liquidato BM, Barros MD, Cordeiro Q, Shiozawa P. Trigeminal Nerve Stimulation (TNS) for Major Depressive Disorder in Pregnancy: A Case Study. Brain Stimul. 2015 Sep-Oct;8(5):988-9. doi: 10.1016/j.brs.2015.07.034. Epub 2015 Jul 23. No abstract available.
25150403	Result	Shiozawa P, Duailibi MS, da Silva ME, Cordeiro Q. Trigeminal nerve stimulation (TNS) protocol for treating major depression: an open-label proof-of-concept trial. Epilepsy Behav. 2014 Oct;39:6-9. doi: 10.1016/j.yebeh.2014.07.021. Epub 2014 Aug 23.