TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial

Study Overview
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Brief Summary
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This is a phase II, randomized, sham controlled, clinical trial. 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.

Official Title
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The Effects of Trigeminal Nerve Stimulation (TNS) for the Treatment of Major Depressive Disorder: a Phase II, Randomized, Sham Controlled Clinical Trial

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Device: Trigeminal Nerve Stimulation (TNS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients between 18 and 69 years patients with a diagnosis of depression according to the SCID score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode) agreement to participate in the study as recommended in the IC. Exclusion Criteria: patients with psychiatric indication for hospitalization patients with psychiatric comorbidity patients with a diagnosis of personality disorder presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trigeminal Nerve Stimulation (TNS)<br>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)<br>* Trigeminal Nerve Stimulation (TNS)<br>|
| Placebo Comparator: Sham<br>TNS 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 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. | Change from baseline in depressive symptoms at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MOCA) | 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 | Change from baseline in cognitive functioning at 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, cranial nerve stimulation, trigeminal stimulation