Depressive Symptoms | TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial
Depressive Symptoms research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. patients between 18 and 69 years 2. patients with a diagnosis of depression according to the SCID 3. score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode) 4. agreement to participate in the study as recommended in the IC. Exclusion Criteria: 1. patients with psychiatric indication for hospitalization 2. patients with psychiatric comorbidity 3. patients with a diagnosis of personality disorder 4. presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Trigeminal Nerve Stimulation (TNS)Trigeminal Nerve Stimulation (TNS)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
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.
ShamTNS 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.
Start Date: May 2014
Phase: Phase 1/Phase 2
Primary Outcome: Hamilton Depressive Rating Scale version 17 items (HDRS-17)
Secondary Outcome: Montreal Cognitive Assessment (MOCA)
Study sponsors, principal investigator, and references
Principal Investigator: Quirino Cordeiro, MD, PhD
Lead Sponsor: Santa Casa Medical School
Collaborator: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Cook IA, Schrader LM, Degiorgio CM, Miller PR, Maremont ER, Leuchter AF. Trigeminal nerve stimulation in major depressive disorder: acute outcomes in an open pilot study. Epilepsy Behav. 2013 Aug;28(2):221-6. doi: 10.1016/j.yebeh.2013.05.008. Epub 2013 Jun 14.