TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial
The Effects of Trigeminal Nerve Stimulation (TNS) for the Treatment of Major Depressive Disorder: a Phase II, Randomized, Sham Controlled Clinical Trial
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2014
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedMay 5, 2015
May 1, 2015
1.1 years
February 10, 2014
May 3, 2015
Conditions
Keywords
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 patients with moderate / severe depressive episode.
Change from baseline in depressive symptoms at 2 weeks
Secondary Outcomes (1)
Montreal Cognitive Assessment (MOCA)
Change from baseline in cognitive functioning at 2 weeks
Study Arms (2)
Trigeminal Nerve Stimulation (TNS)
EXPERIMENTALTNS 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.
Sham
PLACEBO COMPARATORTNS 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.
Interventions
Trigeminal Nerve Stimulation (TNS)
Eligibility Criteria
You may qualify if:
- 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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro de Atencao Integrada à Saúde Mental
São Paulo, São Paulo, 04017030, Brazil
Related Publications (6)
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.
PMID: 23773978BACKGROUNDDeGiorgio 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.
PMID: 21939843BACKGROUNDSchrader 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.
PMID: 21820361BACKGROUNDShiozawa 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.
PMID: 24236617BACKGROUNDRiva-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.
PMID: 24229660BACKGROUNDVuilleumier 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.
PMID: 24158724BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Quirino Cordeiro, MD, PhD
Santa Casa Medical School
- PRINCIPAL INVESTIGATOR
Pedro Shiozawa, MD
Santa Casa Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pedro Shiozawa, Coordinator, Laboratory of Clinical Neuromodulation, Principal Investigator
Study Record Dates
First Submitted
February 10, 2014
First Posted
April 7, 2014
Study Start
May 1, 2014
Primary Completion
June 1, 2015
Last Updated
May 5, 2015
Record last verified: 2015-05