TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial
NCT ID: NCT02105376
Last Updated: 2015-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
44 participants
INTERVENTIONAL
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Trigeminal Nerve Stimulation (TNS)
Trigeminal Nerve Stimulation (TNS)
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.
No interventions assigned to this group
Interventions
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Trigeminal Nerve Stimulation (TNS)
Trigeminal Nerve Stimulation (TNS)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
69 Years
ALL
No
Sponsors
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Faculdade de Ciências Médicas da Santa Casa de São Paulo
OTHER
Santa Casa Medical School
OTHER
Responsible Party
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Pedro Shiozawa
Pedro Shiozawa, Coordinator, Laboratory of Clinical Neuromodulation, Principal Investigator
Principal Investigators
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Quirino Cordeiro, MD, PhD
Role: STUDY_DIRECTOR
Santa Casa Medical School
Pedro Shiozawa, MD
Role: PRINCIPAL_INVESTIGATOR
Santa Casa Medical School
Locations
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Centro de Atencao Integrada à Saúde Mental
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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TNS_depression
Identifier Type: -
Identifier Source: org_study_id
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