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

Primary Purpose

Depressive Symptoms

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Trigeminal Nerve Stimulation (TNS)
Sponsored by
Santa Casa Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring depression, cranial nerve stimulation, trigeminal stimulation

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centro de Atencao Integrada à Saúde MentalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trigeminal Nerve Stimulation (TNS)

Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 10, 2014
Last Updated
May 3, 2015
Sponsor
Santa Casa Medical School
Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02105376
Brief Title
TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Santa Casa Medical School
Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
depression, cranial nerve stimulation, trigeminal stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trigeminal Nerve Stimulation (TNS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Trigeminal Nerve Stimulation (TNS)
Intervention Description
Trigeminal Nerve Stimulation (TNS)
Primary Outcome Measure Information:
Title
Hamilton Depressive Rating Scale version 17 items (HDRS-17)
Description
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.
Time Frame
Change from baseline in depressive symptoms at 2 weeks
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MOCA)
Description
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
Time Frame
Change from baseline in cognitive functioning at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Shiozawa, MD
Phone
55 11 34662100
Email
pedroshiozawa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quirino Cordeiro, MD, PhD
Organizational Affiliation
Santa Casa Medical School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pedro Shiozawa, MD
Organizational Affiliation
Santa Casa Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Atencao Integrada à Saúde Mental
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04017030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Shiozawa, MD
Phone
55 11 34662100
Email
pedroshiozawa@gmail.com
First Name & Middle Initial & Last Name & Degree
Pedro Shiozawa, MD
First Name & Middle Initial & Last Name & Degree
Quirino Cordeiro, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23773978
Citation
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.
Results Reference
background
PubMed Identifier
21939843
Citation
DeGiorgio CM, Fanselow EE, Schrader LM, Cook IA. Trigeminal nerve stimulation: seminal animal and human studies for epilepsy and depression. Neurosurg Clin N Am. 2011 Oct;22(4):449-56, v. doi: 10.1016/j.nec.2011.07.001.
Results Reference
background
PubMed Identifier
21820361
Citation
Schrader LM, Cook IA, Miller PR, Maremont ER, DeGiorgio CM. Trigeminal nerve stimulation in major depressive disorder: first proof of concept in an open pilot trial. Epilepsy Behav. 2011 Nov;22(3):475-8. doi: 10.1016/j.yebeh.2011.06.026. Epub 2011 Aug 4.
Results Reference
background
PubMed Identifier
24236617
Citation
Shiozawa P, Cordeiro Q, Fregni F, Brunoni AR. Is sertraline plus transcranial direct current stimulation the future of effective depression treatment? J Comp Eff Res. 2013 May;2(3):213-5. doi: 10.2217/cer.13.28. No abstract available.
Results Reference
background
PubMed Identifier
24229660
Citation
Riva-Posse P, Hermida AP, McDonald WM. The role of electroconvulsive and neuromodulation therapies in the treatment of geriatric depression. Psychiatr Clin North Am. 2013 Dec;36(4):607-30. doi: 10.1016/j.psc.2013.08.007. Epub 2013 Oct 6.
Results Reference
background
PubMed Identifier
24158724
Citation
Vuilleumier P, Sander D, Baertschi B. Changing the brain, changing the society: clinical and ethical implications of neuromodulation techniques in neurology and psychiatry. Brain Topogr. 2014 Jan;27(1):1-3. doi: 10.1007/s10548-013-0325-7. Epub 2013 Oct 25.
Results Reference
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TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial

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