DepressionEarly Phase 1NCT01192685
Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring
A Early Phase 1 study testing Transcranial Magnetic Stimulation (TMS) and near infrared spectroscopy (NIRS) in people with Depression, run by Boston University at 1 site in United States.
Trial summary
This a 12- week study (1-4 week screening, 6 weeks treatment, 2 weeks follow-up) outpatient open label clinical trial. Twenty-five subjects diagnosed with depression with a Montgomery Asberg Depression Rating Scale (MADRAS) score of 26 or higher, will be enrolled into this trial, up to fifty subjects will be… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) and near infrared spectroscopy (NIRS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2013
- Phase
- Early Phase 1
- 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
- Depressive disorder Diagnostic Statistical Manual of Mental Disorders, fourth Edition, Text Revision (DSM-IV-TR).
- MADRAS score of 26 or above and history of depression, as defined by meeting DSM-IV criteria for major depression, dysthymic disorder, or substance-induced mood disorder.
- Male or female aged 18 to 65.
- Females who are not pregnant or nursing.
- Individuals able to provide informed written consent and are able to comply with study procedures.
- Subjects who have received or are receiving anti-depressant medication.
- Patients who are depressed as assessed by the above criteria and have not had optimum response to their antidepressant medication in their current episode.
Who cannot join
- Any Axis I diagnosis that, in the opinion of the investigators, may interfere with the course of the trial.
- Any current diagnoses of alcohol abuse or dependence.
- Any current substance use disorder.
- Medical or neurological illness that in the investigators judgment would make study compliance difficult or would be a contraindication for use with TMS.
- Currently receiving any medication that markedly increases the risks for seizures, for example: tricyclic antidepressants, INH, meperidine, lidocaine, and clozapine.
- Subjects who have implanted metallic devices or non-removable metallic objects in or around the head that can be magnetized, however metal fillings, braces, and dental implants are acceptable.
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- Subjects who have implanted devices that emit physiological signals including cardioverter defibrillators (ICDs), and vagus nerve stimulators.
- Subjects who have received any investigational drug during the prior 30 days.
- Clinically significant abnormal lab values as assesses by the Investigator.
- Risk for suicidal behavior based on clinician assessment and a score of greater than 5 on the suicidal thought item of the MADRS or a score of 4 on the suicide item of the Hamilton Depression rating scale.
- Subjects who have had a serious suicide attempt in the past year as assessed by the Investigator.
- Current other somatic antidepressant therapy, i.e. vagus nerve stimulation, electroconvulsive therapy, or phototherapy.
- Started psychotherapy in the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Magnetic Stimulation in Major Depression With EEG and NIRS Monitoring
This a 12- week study (1-4 week screening, 6 weeks treatment, 2 weeks follow-up) outpatient open label clinical trial. Twenty-five subjects diagnosed with depression with a Montgomery Asberg Depression Rating Scale (MADRAS) score of 26 or higher, will be enrolled into this trial, up to fifty subjects will be consented. The primary purpose of the current study is to determine: 1) if changes in electrical activity of the brain measured by EEG in specific areas is associated with changes in the blood flow of the brain 2) Which areas of the brain show changes in electrical activity and treatment response.
Read the detailed description
Transcranial magnetic stimulation (TMS) has demonstrated efficacy as a treatment for major depression. No objective markers have been identified that indicate which patients are most likely to respond to TMS therapy. The goal of the present investigation is to determine whether an electroencephalographic measure called cordance or a measure of blood flow in the frontal brain, as measured by near infrared spectroscopy (NIRS) can serve as predictors of outcome with TMS therapy in depression. Subjects with depression will be treated in this study for 6 weeks with TMS. Frontal brain blood flow measured using NIRS will be assessed prior to TMS therapy, and repeatedly thereafter. EEG cordance will also be obtained following a similar schedule. Measures of depression and other psychiatric disorders will be collected prior to, during and for 2 weeks after the completion of TMS treatment. The correlation between these measures and the EEG and NIRS measures will then be determined to see if these latter measures are predictive of improvement in depression.
- Conditions
- Depression
- Being tested
- Transcranial Magnetic Stimulation (TMS), near infrared spectroscopy (NIRS)
- Keywords
- Depression, Depressed, TMS, Transcranial Magnetic Stimulation
- Medical subject headings
- Depression, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Procedure or surgery
TMS will be administered to subjects 5 days a week-typically Monday through Friday, for 6 weeks.
near infrared spectroscopy (NIRS)Device
near infrared spectroscopy (NIRS) will be used to measure the blood flow in the brain
| Study group | Role | What they receive |
|---|---|---|
| Depressed outpatients treated with TMS | Other | This a 12- week study (1-4 week screening, 6 weeks treatment, 2 weeks follow-up) outpatient open label clinical trial. Twenty-five subjects diagnosed with depression with a Montgomery Asberg Depression Rating Scale (MADRAS) score of 26 or higher, will be enrolled into this trial, up to fifty subjects will be consented. Transcranial Magnetic Stimulation (TMS) will be administered to subjects 5 days a week for 6 weeks. Near infrared spectroscopy (NIRS), a spectroscopic method that uses the near infrared region of the electromagnetic spectrum (from about 700 nm to 2500 nm), will be used to assess blood flow in the brain. Receives: Procedure: Transcranial Magnetic Stimulation (TMS); Device: near infrared spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlations between EEG cordance or task-induced changes in frontal total Hb levels
The primary outcome will be the correlations between EEG cordance or task-induced changes in frontal total Hb levels and changes in MADRAS scores between baseline and the last treatment day. Correlations between these measures will be determined between other cordance and total Hb levels obtained after the first week of treatment and MADRAS changes for the last day of treatment. Similar analyses will be conducted for changes in MADRAS scores between baseline and the follow-up visit.
Measured: 6 weeks
Changes in MADRAS scores between baseline and the last treatment day
The primary outcomes will be the correlations between EEG cordance or task-induced changes in frontal total Hb levels and changes in MADRAS scores between baseline and the last treatment day. Correlations between these measures will be determined between other cordance and total Hb levels obtained after the first week of treatment and MADRAS changes for the last day of treatment. Similar analyses will be conducted for changes in MADRAS scores between baseline and the follow-up visit.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Neuronavigation system equipment failure caused unreliable data
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 Boston UniversityThe 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
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center
- Responsible party
- Sponsor
- Investigators
- Ofra Sarid-Segal, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192685
- Sponsor's protocol ID
- H-29098
- Status last verified
- Apr 2017
- First submitted
- 30 Aug 2010
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation in Major Depression With EEG and NIRS Monitoring
- ClinicalTrials.gov ID
- NCT01192685
- Acronym / sponsor ID
- H-29098
- Conditions
- Depression
- Keywords
- Depression, Depressed, TMS, Transcranial Magnetic Stimulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Neuronavigation system equipment failure caused unreliable data
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Boston Medical Center
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Sep 2010 (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 a 12- week study (1-4 week screening, 6 weeks treatment, 2 weeks follow-up) outpatient open label clinical trial. Twenty-five subjects diagnosed with depression with a Montgomery Asberg Depression Rating Scale (MADRAS) score of 26 or higher, will be enrolled into this trial, up to fifty subjects will be consented. The primary purpose of the current study is to determine: 1) if changes in electrical activity of the brain measured by EEG in specific areas is associated with changes in the blood flow of the brain 2) Which areas of the brain show changes in electrical activity and treatment response.
Detailed description
Transcranial magnetic stimulation (TMS) has demonstrated efficacy as a treatment for major depression. No objective markers have been identified that indicate which patients are most likely to respond to TMS therapy. The goal of the present investigation is to determine whether an electroencephalographic measure called cordance or a measure of blood flow in the frontal brain, as measured by near infrared spectroscopy (NIRS) can serve as predictors of outcome with TMS therapy in depression. Subjects with depression will be treated in this study for 6 weeks with TMS. Frontal brain blood flow measured using NIRS will be assessed prior to TMS therapy, and repeatedly thereafter. EEG cordance will also be obtained following a similar schedule. Measures of depression and other psychiatric disorders will be collected prior to, during and for 2 weeks after the completion of TMS treatment. The correlation between these measures and the EEG and NIRS measures will then be determined to see if these latter measures are predictive of improvement in depression.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depressed outpatients treated with TMS | Other | Procedure: Transcranial Magnetic Stimulation (TMS), Device: near infrared spectroscopy (NIRS)This a 12- week study (1-4 week screening, 6 weeks treatment, 2 weeks follow-up) outpatient open label clinical trial. Twenty-five subjects diagnosed with depression with a Montgomery Asberg Depression Rating Scale (MADRAS) score of 26 or higher, will be enrolled into this trial, up to fifty subjects will be consented. Transcranial Magnetic Stimulation (TMS) will be administered to subjects 5 days a week for 6 weeks. Near infrared spectroscopy (NIRS), a spectroscopic method that uses the near infrared region of the electromagnetic spectrum (from about 700 nm to 2500 nm), will be used to assess blood flow in the brain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Depressive disorder Diagnostic Statistical Manual of Mental Disorders, fourth Edition, Text Revision (DSM-IV-TR).
- MADRAS score of 26 or above and history of depression, as defined by meeting DSM-IV criteria for major depression, dysthymic disorder, or substance-induced mood disorder.
- Male or female aged 18 to 65.
- Females who are not pregnant or nursing.
- Individuals able to provide informed written consent and are able to comply with study procedures.
Key exclusion criteria (13 listed)
- Any Axis I diagnosis that, in the opinion of the investigators, may interfere with the course of the trial.
- Any current diagnoses of alcohol abuse or dependence.
- Any current substance use disorder.
- Medical or neurological illness that in the investigators judgment would make study compliance difficult or would be a contraindication for use with TMS.
- Currently receiving any medication that markedly increases the risks for seizures, for example: tricyclic antidepressants, INH, meperidine, lidocaine, and clozapine.
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)TMS will be administered to subjects 5 days a week-typically Monday through Friday, for 6 weeks. | Procedure or surgery | Depressed outpatients treated with TMS |
| near infrared spectroscopy (NIRS)near infrared spectroscopy (NIRS) will be used to measure the blood flow in the brain | Device | Depressed outpatients treated with TMS |
Primary outcome
The correlations between EEG cordance or task-induced changes in frontal total Hb levels
Time frame: 6 weeks
The primary outcome will be the correlations between EEG cordance or task-induced changes in frontal total Hb levels and changes in MADRAS scores between baseline and the last treatment day. Correlations between these measures will be determined between other cordance and total Hb levels obtained after the first week of treatment and MADRAS changes for the last day of treatment. Similar analyses will be conducted for changes in MADRAS scores between baseline and the follow-up visit.
Changes in MADRAS scores between baseline and the last treatment day
Time frame: 6 Weeks
The primary outcomes will be the correlations between EEG cordance or task-induced changes in frontal total Hb levels and changes in MADRAS scores between baseline and the last treatment day. Correlations between these measures will be determined between other cordance and total Hb levels obtained after the first week of treatment and MADRAS changes for the last day of treatment. Similar analyses will be conducted for changes in MADRAS scores between baseline and the follow-up visit.
Results and safety
The study was stopped early (reason given: Neuronavigation system equipment failure caused unreliable data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Ofra Sarid-Segal, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Transcranial Magnetic Stimulation (TMS) and near infrared spectroscopy (NIRS) in people with Depression, run by Boston University 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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 20 Apr 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Neuronavigation system equipment failure caused unreliable data). Results are not available in the source record.
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?
The correlations between EEG cordance or task-induced changes in frontal total Hb levels (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 20 Apr 2017.