A Phase 1/2 interventional study of Transcutaneous Vagus Nerve Stimulation in Depressive Disorder, sponsored by Santa Casa Medical School. Status unknown. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2015-09-29.
Sponsored by Santa Casa Medical School · Phase 1/2, Interventional, and Treatment
This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Santa Casa Medical School is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
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.
• 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.
Time frame: Change from baseline in depressive symptoms at 2 weeks
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Santa Casa Medical School