tVNS for Depression

Santa Casa Medical School

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Depressive Disorder

Treatments: Device: Transcutaneous Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02562703

tVNS

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

ACTIVE tVNS

Active Comparator group

Description:

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.

Treatment:

Device: Transcutaneous Vagus Nerve Stimulation

SHAM tVNS

Sham Comparator group

Description:

tVNS will be applied by the external simulator (Monarch). The stimulation will be turned off after 60 seconds following previous trials.

Treatment:

Device: Transcutaneous Vagus Nerve Stimulation