DepressionPhase 2NCT01343563
Trigeminal Nerve Stimulation for Depression: Dose Finding
A Phase 2 study testing Trigeminal Nerve Stimulation in people with Depression, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) when added onto antidepressant medications. Our primary objective is the examination of two different "doses" of TNS, in terms of pulse frequency. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Trigeminal Nerve Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2012
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with non-psychotic, unipolar Major Depressive Disorder assessed via the MINI structured interview
- A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
- A history of treatment failure with at least one adequate trial of an antidepressant over the previous 6 weeks, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study)
- Age range: 18 to 65 years old.
- Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm.
Who cannot join
- Patient is mentally or legally incapacitated, unable to give informed consent.
- Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
- Patients with exposure to ECT or VNS within the past 6 months.
- Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
- current pregnancy, breast feeding, plans to become pregnant in the 12-week treatment phase of the study, or not using a medically accepted means of contraception.
- Other medical contraindications to any of the study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Semel Institute for Neuroscience and Human Behavior at UCLA
Los Angeles, California, 90024
About this study
This study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) when added onto antidepressant medications. Our primary objective is the examination of two different "doses" of TNS, in terms of pulse frequency.
To accomplish our specific aims, the investigators will test the following specific hypotheses:
- Subjects will show greater improvement in ratings of mood and other symptoms of depression during the six-week of high frequency stimulation than during low frequency stimulation periods.
- Subjects will show greater improvement after 12 weeks of high frequency stimulation than after six weeks of high frequency stimulation.
- Subjects will show improvement in ratings of life functional capacity and quality of life with TNS.
- Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.
- Subjects will show significant differences in regional brain function at the end of the high frequency stimulation period compared with baseline, and significant differences between high and low frequency stimulation conditions.
Read the detailed description
A total of 20 subjects with Major Depressive Disorder (MDD), ages 18 to 65, will be consented and join this project at UCLA.
The project has two phases: a 12 week treatment phase and a 6 month follow-up phase. In the first phase, a double-blind one-way cross-over design will allow us to compare the clinical and physiologic responses to TNS at two frequencies of stimulation, "high" (~120 Hz) and "low " (~20 Hz). Subjects will be randomized to start a six week period at either high or low frequency stimulation (n=10 in each); both subjects and the staff who interact with them will be blinded to assignment, and a separate member of the team will program the device settings. At the six week point, the low frequency group subjects will be crossed over to high frequency, while the high frequency group will continue at high frequency. At the end of the 12 weeks, the TNS systems will be returned and the adjunctive treatment will end. All subjects will be followed for another six months with monthly telephone calls to monitor symptoms or changes in treatment that would signal a return of symptoms. The primary endpoint is the change in depression severity for the two groups at the week 6 visit.
- Conditions
- Depression
- Being tested
- Trigeminal Nerve Stimulation
- Keywords
- Depression, Major Depressive Disorder (MDD), EEG, Trigeminal Nerve Stimulation
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigeminal Nerve StimulationProcedure or surgery
External trigeminal nerve stimulation (TNS) as an adjunctive treatment added onto antidepressant medications.
| Study group | Role | What they receive |
|---|---|---|
| Low frequency to High | Active comparator | For the first six weeks, subjects randomized to this group will receive low frequency stimulation. At the six week point, the low frequency group subjects will be crossed over to high frequency for the remaining six weeks. Receives: Procedure: Trigeminal Nerve Stimulation |
| High frequency | Active comparator | Subjects randomized to this group will receive high frequency stimulation for the entire 12 weeks of the first phase of this study. Receives: Procedure: Trigeminal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale 17 score
Measured: baseline, week 6, week 12
Secondary outcomes (4)
Change in life functional capacity and quality of life scales
Life functional capacity and quality of life scales include: Short-form Health Survey-36 Item and Quality of Life Enjoyment and Satisfaction Questionnaire
Measured: baseline, week 6, week 12
Changes in Regional Brain Function
As measured by qualitative electroencephalographic (QEEG) recordings
Measured: baseline, week 6, week 12
Changes in vital signs recordings
Autonomic function (i.e. pulse and blood pressure) are monitored for 30 mins of stimulation at baseline, week 6, and week 12. Resting vital signs are recorded for each visit.
Measured: At every visit for 12 weeks
Changes in Safety Assessment Measures
Safety Assessment measures will be administered at each visit and include: Survey of Acceptability of TNS, Systematic Assessment for Treatment Emergent Events-Systematic Inquiry (SAFTEE-SI), and Frequency, Intensity, and Burden of Side Effects Scale (FIBSER)
Measured: At every visit for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian A. Cook, M.D., University of California, Los Angeles
- Investigators
- Ian A Cook, MD, Principal investigator, Semel Institute for Neuroscience and Human Behavior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343563
- Sponsor's protocol ID
- 10-000480
- Other IDs
- 10-000480
- Status last verified
- Feb 2013
- First submitted
- 5 Apr 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigeminal Nerve Stimulation for Depression: Dose Finding
- ClinicalTrials.gov ID
- NCT01343563
- Acronym / sponsor ID
- 10-000480
- Conditions
- Depression
- Keywords
- Depression, Major Depressive Disorder (MDD), EEG, Trigeminal Nerve Stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Apr 2011 (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 study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) when added onto antidepressant medications. Our primary objective is the examination of two different "doses" of TNS, in terms of pulse frequency.
To accomplish our specific aims, the investigators will test the following specific hypotheses:
- Subjects will show greater improvement in ratings of mood and other symptoms of depression during the six-week of high frequency stimulation than during low frequency stimulation periods.
- Subjects will show greater improvement after 12 weeks of high frequency stimulation than after six weeks of high frequency stimulation.
- Subjects will show improvement in ratings of life functional capacity and quality of life with TNS.
- Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.
- Subjects will show significant differences in regional brain function at the end of the high frequency stimulation period compared with baseline, and significant differences between high and low frequency stimulation conditions.
Detailed description
A total of 20 subjects with Major Depressive Disorder (MDD), ages 18 to 65, will be consented and join this project at UCLA.
The project has two phases: a 12 week treatment phase and a 6 month follow-up phase. In the first phase, a double-blind one-way cross-over design will allow us to compare the clinical and physiologic responses to TNS at two frequencies of stimulation, "high" (~120 Hz) and "low " (~20 Hz). Subjects will be randomized to start a six week period at either high or low frequency stimulation (n=10 in each); both subjects and the staff who interact with them will be blinded to assignment, and a separate member of the team will program the device settings. At the six week point, the low frequency group subjects will be crossed over to high frequency, while the high frequency group will continue at high frequency. At the end of the 12 weeks, the TNS systems will be returned and the adjunctive treatment will end. All subjects will be followed for another six months with monthly telephone calls to monitor symptoms or changes in treatment that would signal a return of symptoms. The primary endpoint is the change in depression severity for the two groups at the week 6 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low frequency to High | Active comparator | Procedure: Trigeminal Nerve StimulationFor the first six weeks, subjects randomized to this group will receive low frequency stimulation. At the six week point, the low frequency group subjects will be crossed over to high frequency for the remaining six weeks. |
| High frequency | Active comparator | Procedure: Trigeminal Nerve StimulationSubjects randomized to this group will receive high frequency stimulation for the entire 12 weeks of the first phase of this study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients with non-psychotic, unipolar Major Depressive Disorder assessed via the MINI structured interview
- A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
- A history of treatment failure with at least one adequate trial of an antidepressant over the previous 6 weeks, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study)
- Age range: 18 to 65 years old.
- Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm.
Key exclusion criteria (6 listed)
- Patient is mentally or legally incapacitated, unable to give informed consent.
- Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
- Patients with exposure to ECT or VNS within the past 6 months.
- Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
- current pregnancy, breast feeding, plans to become pregnant in the 12-week treatment phase of the study, or not using a medically accepted means of contraception.
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 StimulationExternal trigeminal nerve stimulation (TNS) as an adjunctive treatment added onto antidepressant medications. | Procedure or surgery | High frequency, Low frequency to High |
Primary outcome
Change in Hamilton Depression Rating Scale 17 score
Time frame: baseline, week 6, week 12
4 secondary outcomes
Change in life functional capacity and quality of life scales
Time frame: baseline, week 6, week 12
Changes in Regional Brain Function
Time frame: baseline, week 6, week 12
Changes in vital signs recordings
Time frame: At every visit for 12 weeks
Changes in Safety Assessment Measures
Time frame: At every visit for 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
Related trials for Depression
Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
Recruiting
EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
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.
Ian A Cook, MD principal investigator
Semel Institute for Neuroscience and Human Behavior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trigeminal Nerve Stimulation in people with Depression, run by University of California, Los Angeles at 1 site in United States.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 6 Feb 2013. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale 17 score (time frame: baseline, week 6, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2013.