Depressive SymptomsPhase 1/2NCT02105376
TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial
A Phase 1/2 study testing Trigeminal Nerve Stimulation (TNS) in people with Depressive Symptoms, run by Santa Casa Medical School at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Trigeminal Nerve Stimulation (TNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Jun 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Atencao Integrada à Saúde Mental
São Paulo, São Paulo, 04017030
Pedro Shiozawa, MD, 55 11 34662100, pedroshiozawa@gmail.com
Pedro Shiozawa, MD
About this study
Official title: The Effects of Trigeminal Nerve Stimulation (TNS) for the Treatment of Major Depressive Disorder: a Phase II, Randomized, Sham Controlled Clinical Trial
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.
- Conditions
- Depressive Symptoms
- Being tested
- Trigeminal Nerve Stimulation (TNS)
- Keywords
- depression, cranial nerve stimulation, trigeminal stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigeminal Nerve Stimulation (TNS)Device
Trigeminal Nerve Stimulation (TNS)
| Study group | Role | What they receive |
|---|---|---|
| Trigeminal Nerve Stimulation (TNS) | Experimental | 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. Receives: Device: Trigeminal Nerve Stimulation (TNS) |
| Sham | Placebo comparator | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline in depressive symptoms at 2 weeks
Secondary outcomes (1)
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
Measured: Change from baseline in cognitive functioning at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santa Casa Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Responsible party
- Principal investigator, Pedro Shiozawa, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Investigators
- Quirino Cordeiro, MD, PhD, Study director, Santa Casa Medical SchoolPedro Shiozawa, MD, Principal investigator, Santa Casa Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105376
- Sponsor's protocol ID
- TNS_depression
- Status last verified
- May 2015
- First submitted
- 10 Feb 2014
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23773978DeGiorgio 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.
PubMed 21939843Schrader 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.
PubMed 21820361Shiozawa 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.
PubMed 24236617Riva-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.
PubMed 24229660Vuilleumier 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.
PubMed 24158724
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Trigeminal Nerve Stimulation (TNS) for the Treatment of Major Depressive Disorder: a Phase II, Randomized, Sham Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02105376
- Acronym / sponsor ID
- TNS_depression
- Conditions
- Depressive Symptoms
- Keywords
- depression, cranial nerve stimulation, trigeminal stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Santa Casa Medical SchoolUniversity, hospital or other
- Collaborators
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Study start
- May 2014
- Primary completion
- Jun 2015 (estimated)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trigeminal Nerve Stimulation (TNS) | Experimental | Device: 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. |
| Sham | Placebo comparator | –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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trigeminal Nerve Stimulation (TNS)Trigeminal Nerve Stimulation (TNS) | Device | Trigeminal Nerve Stimulation (TNS) |
Primary outcome
Hamilton Depressive Rating Scale version 17 items (HDRS-17)
Time frame: 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.
1 secondary outcome
Montreal Cognitive Assessment (MOCA)
Time frame: Change from baseline in cognitive functioning at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
- Background: PubMed 23773978Cook 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.
- Background: PubMed 21939843DeGiorgio 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.
- Background: PubMed 21820361Schrader 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.
- Background: PubMed 24236617Shiozawa 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.
- Background: PubMed 24229660Riva-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.
- Background: PubMed 24158724Vuilleumier 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.
Related trials for Depressive Symptoms
Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
Major Depressive Disorder
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Major Depressive Disorder (MDD), Depression in Adults
RecruitingObservational study
The Immunobiological Mechanisms of Depression in Perimenopause
Perimenopause, Major Depressive Episode (MDE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quirino Cordeiro, MD, PhD study director
Santa Casa Medical School
Pedro Shiozawa, MD principal investigator
Santa Casa Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trigeminal Nerve Stimulation (TNS) in people with Depressive Symptoms, run by Santa Casa Medical School at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Shiozawa, MD (55 11 34662100, pedroshiozawa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depressive Rating Scale version 17 items (HDRS-17) (time frame: Change from baseline in depressive symptoms at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02105376, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.