TNS for Treating Major Depressive Disorder in the Elderly

NCT02562677 | Unknown Phase 1

• 1 other identifier: TNS for Elderly
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase II, open-label clinical trial. This clinical trial has as primary objective to evaluate changes in EEG of a Trigeminal Nerve Stimulation (TNS) treatment protocol for elderly patients with moderate / severe depressive episode.

Conditions

Major Depressive Disorder; Elderly

Outcome Measures

Primary Outcomes (1)

• 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 elderly patients with moderate / severe depressive episode

  Change from baseline in depressive symptoms at 2 weeks ]

Study Arms (1)

ACTIVE tNS

EXPERIMENTAL

TNS 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 on the forehead just above the supraorbital foramen bilaterally. The study protocol will follow the rational of our previous trials with TNS.

Device: Transcutaneous Trigeminal Nerve Stimulation

Interventions

Transcutaneous Trigeminal Nerve Stimulation DEVICE

ACTIVE tNS

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patients between 65 and 99 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santa Casa Medical School: lead

Related Publications (2)

• Shiozawa P, Duailibi MS, da Silva ME, Cordeiro Q. Trigeminal nerve stimulation (TNS) protocol for treating major depression: an open-label proof-of-concept trial. Epilepsy Behav. 2014 Oct;39:6-9. doi: 10.1016/j.yebeh.2014.07.021. Epub 2014 Aug 23.

  PMID: 25150403 RESULT

• Shiozawa P, Silva ME, Carvalho TC, Cordeiro Q, Brunoni AR, Fregni F. Transcutaneous vagus and trigeminal nerve stimulation for neuropsychiatric disorders: a systematic review. Arq Neuropsiquiatr. 2014 Jul;72(7):542-7. doi: 10.1590/0004-282x20140061.

  PMID: 25054988 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Alisson P Trevizol, MD

CONTACT

alisson.trevizol@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator - Interdisciplinary Center for Clinical Neuromodulation

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: September 29, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: September 29, 2015

Record last verified: 2015-09