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

Sponsor
Santa Casa Medical School (Other)
Overall Status
Unknown status
CT.gov ID
NCT02105376
Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo (Other)
44
Enrollment
1
Location
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Trigeminal Nerve Stimulation (TNS)
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: Trigeminal Nerve Stimulation (TNS)
Trigeminal Nerve Stimulation (TNS)
Placebo Comparator: Sham

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.

Outcome Measures

Primary Outcome Measures

  1. Hamilton Depressive Rating Scale version 17 items (HDRS-17) [Change from baseline in depressive symptoms at 2 weeks]

    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

  1. Montreal Cognitive Assessment (MOCA) [Change from baseline in cognitive functioning at 2 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro de Atencao Integrada à Saúde Mental Sao Paulo SP Brazil 04017030

Sponsors and Collaborators

  • Santa Casa Medical School
  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

Investigators

  • Study Director: Quirino Cordeiro, MD, PhD, Santa Casa Medical School
  • Principal Investigator: Pedro Shiozawa, MD, Santa Casa Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Pedro Shiozawa, Pedro Shiozawa, Coordinator, Laboratory of Clinical Neuromodulation, Principal Investigator, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier:
NCT02105376
Other Study ID Numbers:
  • TNS_depression
First Posted:
Apr 7, 2014
Last Update Posted:
May 5, 2015
Last Verified:
May 1, 2015
Keywords provided by Pedro Shiozawa, Pedro Shiozawa, Coordinator, Laboratory of Clinical Neuromodulation, Principal Investigator, Faculdade de Ciências Médicas da Santa Casa de São Paulo
depression
cranial nerve stimulation
trigeminal stimulation
Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major

Study Results

No Results Posted as of May 5, 2015