TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT02105376|
Recruitment Status : Unknown
Verified May 2015 by Pedro Shiozawa, Faculdade de Ciências Médicas da Santa Casa de São Paulo.
Recruitment status was: Recruiting
First Posted : April 7, 2014
Last Update Posted : May 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms||Device: Trigeminal Nerve Stimulation (TNS)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of Trigeminal Nerve Stimulation (TNS) for the Treatment of Major Depressive Disorder: a Phase II, Randomized, Sham Controlled Clinical Trial|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||June 2015|
Experimental: Trigeminal Nerve Stimulation (TNS)
TNS active group
TNS will be applied by the external simulator EMS400. The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 200 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia (approximately 0.5-2mA). The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed on the forehead just above the supraorbital foramen bilaterally.
Device: Trigeminal Nerve Stimulation (TNS)
Trigeminal Nerve Stimulation (TNS)
Placebo Comparator: Sham
The placebo intervention will consist of an initial stimulation until a mild paresthesia is achieved, and then turn off the machine after 60 seconds, after which period there is a tendency of reduction natural feeling secondary to skin sensitization paresthesia.
- Hamilton Depressive Rating Scale version 17 items (HDRS-17) [ Time Frame: Change from baseline in depressive symptoms at 2 weeks ]This clinical trial has as primary objective to evaluate the effect of the Trigeminal Nerve Stimulation (TNS) on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.
- Montreal Cognitive Assessment (MOCA) [ Time Frame: Change from baseline in cognitive functioning at 2 weeks ]We also use the questionnaire Montreal Cognitive Assessment (MOCA) for assessment of cognitive function, considering the level of consciousness and global functioning in order to compare your score with estimates made by other instruments. It will also serve to assess possible cognitive damage and whether there are improvements in some specific cognitive functions with treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105376
|Contact: Pedro Shiozawa, MD||55 11 firstname.lastname@example.org|
|Centro de Atencao Integrada à Saúde Mental||Recruiting|
|Sao Paulo, SP, Brazil, 04017030|
|Contact: Pedro Shiozawa, MD 55 11 34662100 email@example.com|
|Principal Investigator: Pedro Shiozawa, MD|
|Sub-Investigator: Quirino Cordeiro, MD, PhD|
|Study Director:||Quirino Cordeiro, MD, PhD||Santa Casa Medical School|
|Principal Investigator:||Pedro Shiozawa, MD||Santa Casa Medical School|