DepressionNCT02222012
Neuromarkers Identification in Major Depressive Disorder Based on Monitoring Measures
A study testing single channel "Multiway Coil®" and Two channels "Multiway stimulator coil®" (Brainsway Ltd.) in people with Depression, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
The investigators propose a multi-source pattern which integrates neuroimaging data associated with multiple, symptom-related neural processes relevant in depression to improve classification accuracy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- single channel "Multiway Coil®" and Two channels "Multiway stimulator coil®" (Brainsway Ltd.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2014to Sep 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatient
- Diagnosed by senior psychiatrist as suffering from major depression episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID).
- Rating on HDRS-21>20.
- Age: 18-68 years.
- Treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF ( antidepressant treatment history form) instruction guidelines .
- Gave informed consent for participation in the study.
- Negative answers on safety screening questionnaire for transcranial magnetic stimulation.
Who cannot join
- Diagnosis as suffering from other diagnosis on axis 1 ( like: schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
- Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.
- Substantial suicidal risk as judged by the treating psychiatrist.
- Attempted suicide in the past year.
- Any current unstable medical or surgical illness.
- History of seizure or heat convulsion.
Show all 17Show fewer
- History of epilepsy or seizure in first degree relatives.
- History of head injury.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips, cochlear implants or any medical pumps.
- History of hearing loss.
- History of drug abuse or alcoholism in the last 6 month.
- Pregnancy or not using a reliable method of birth control.
- Systematic and metabolic unstable disorders.
- Inadequate communication with the patient.
- Under custodial care.
- Participation in current clinical study or clinical study within 30 days prior to this study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shalvata Mental Health Center
Hod HaSharon
Yechiel MD Levkovitz, Phd
Yuval Bloch, MD Phd
About this study
Official title: Identification of Neuromarkers in Novel Neuromodulation Treatment in Major Depressive Disorder Based on Integration of Multiple Monitoring Measures
The investigators propose a multi-source pattern which integrates neuroimaging data associated with multiple, symptom-related neural processes relevant in depression to improve classification accuracy. The investigators conclude that combining brain activation related to the core-symptoms of depression using the multi-source monitoring data substantially increases classification accuracy while providing a sparse relational neuromarkers-model for future prediction.
Read the detailed description
The "Multiway stimulator coil®" (Brainsway Ltd.) is a novel TMS stimulator with several new and unique properties. Currently standard TMS devices include a single channel, and can operate only a single coil. The "Multiway stimulator coil®" (Brainsway Ltd.) includes two channels which can operate two independent TMS coils, either simultaneously or sequentially.
The "Multiway stimulator coil®" (Brainsway Ltd.) may be used to obtain a differential activation of various brain regions. For instance it can be used to induce high frequency stimulation of a certain brain region, thus inducing facilitation, while simultaneously stimulate at low frequency in another brain region, leading to inhibition.
In the current study the investigators propose a multi-source pattern which integrates neuroimaging data associated with multiple, symptom-related neural processes relevant in depression to improve classification accuracy. The investigators conclude that combining brain activation related to the core-symptoms of depression using the multi-source monitoring data substantially increases classification accuracy while providing a sparse relational neuromarkers-model for future prediction.
The purpose of the study is to to monitor and optimize the anti depressive effect of brain modulation technique using novel multi model monitoring approach.
Subjects will be treated with one of two designs of the study device (the "Multiway Coil®"):
- Single Channel with a coil placed over the left PFC (10 Hz).
- Two channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC.
All subjects in the current study will undergo monitoring procedure inclusive of functional MRI and electroencephalogram.
- Conditions
- Depression
- Being tested
- single channel "Multiway Coil®", Two channels "Multiway stimulator coil®" (Brainsway Ltd.)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single channel "Multiway Coil®"Device
During the single channel treatment trial period the patients will receive the following dose of rTMS: 10 Hz - left DLPFC ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks).
Two channels "Multiway stimulator coil®" (Brainsway Ltd.)Device
During the two channels treatment trial period the patients will receive the following dose of rTMS: 10 Hz- left DLPFC, 1Hz - right DLPFC together.
10 Hz protocol: ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks)
1 Hz protocol:
1 Hz, at 120% MT, 5 min pulse train, 1 min inter-train interval, 6 trains, i.e. a total of 1800 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 36,000 pulses in 4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| single channel | Active comparator | Not described Receives: Device: single channel "Multiway Coil®" |
| Two channels "Multiway stimulator coil®" (Brainsway Ltd.) | Experimental | Not described Receives: Device: Two channels "Multiway stimulator coil®" (Brainsway Ltd.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical antidepressant response as defined by decline of HDRS-21 score over time
Clinical antidepressant response at the end of the treatment, defined as a decline in Hamilton depression rating scale (HDRS-21) from the baseline rating by 50%.
Measured: 20 day
Secondary outcomes (4)
Symptomatic improvement
Symptomatic improvement at the 4-week end point as measured with Hamilton Anxiety Rating Scale ( HARS)
Measured: day 20
Clinical antidepressant remission as defined by decline of HDRS-21 score over time
Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.
Measured: Day 20
Symptomatic improvement
Symptomatic improvement at the 4-week end point as measured with Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Measured: day 20
Symptomatic improvement
Symptomatic improvement at the 4-week end point as measured with Clinical Global Impression (CGI)
Measured: day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2014 (estimated)
- Study completionSep 2017 (estimated)
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.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beer Yaakov Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Yuval Bloch, Md, Phd, Principal investigator, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222012
- Sponsor's protocol ID
- sha-04-14
- Status last verified
- Aug 2014
- First submitted
- 17 Aug 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Neuromarkers in Novel Neuromodulation Treatment in Major Depressive Disorder Based on Integration of Multiple Monitoring Measures
- ClinicalTrials.gov ID
- NCT02222012
- Acronym / sponsor ID
- sha-04-14
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- Beer Yaakov Mental Health Center
- Study start
- Aug 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 21 Aug 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.
The investigators propose a multi-source pattern which integrates neuroimaging data associated with multiple, symptom-related neural processes relevant in depression to improve classification accuracy. The investigators conclude that combining brain activation related to the core-symptoms of depression using the multi-source monitoring data substantially increases classification accuracy while providing a sparse relational neuromarkers-model for future prediction.
Detailed description
The "Multiway stimulator coil®" (Brainsway Ltd.) is a novel TMS stimulator with several new and unique properties. Currently standard TMS devices include a single channel, and can operate only a single coil. The "Multiway stimulator coil®" (Brainsway Ltd.) includes two channels which can operate two independent TMS coils, either simultaneously or sequentially.
The "Multiway stimulator coil®" (Brainsway Ltd.) may be used to obtain a differential activation of various brain regions. For instance it can be used to induce high frequency stimulation of a certain brain region, thus inducing facilitation, while simultaneously stimulate at low frequency in another brain region, leading to inhibition.
In the current study the investigators propose a multi-source pattern which integrates neuroimaging data associated with multiple, symptom-related neural processes relevant in depression to improve classification accuracy. The investigators conclude that combining brain activation related to the core-symptoms of depression using the multi-source monitoring data substantially increases classification accuracy while providing a sparse relational neuromarkers-model for future prediction.
The purpose of the study is to to monitor and optimize the anti depressive effect of brain modulation technique using novel multi model monitoring approach.
Subjects will be treated with one of two designs of the study device (the "Multiway Coil®"):
- Single Channel with a coil placed over the left PFC (10 Hz).
- Two channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC.
All subjects in the current study will undergo monitoring procedure inclusive of functional MRI and electroencephalogram.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single channel | Active comparator | Device: single channel "Multiway Coil®" |
| Two channels "Multiway stimulator coil®" (Brainsway Ltd.) | Experimental | Device: Two channels "Multiway stimulator coil®" (Brainsway Ltd.) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Outpatient
- Diagnosed by senior psychiatrist as suffering from major depression episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID).
- Rating on HDRS-21>20.
- Age: 18-68 years.
- Treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF ( antidepressant treatment history form) instruction guidelines .
Key exclusion criteria (17 listed)
- Diagnosis as suffering from other diagnosis on axis 1 ( like: schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
- Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.
- Substantial suicidal risk as judged by the treating psychiatrist.
- Attempted suicide in the past year.
- Any current unstable medical or surgical illness.
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 |
|---|---|---|
| single channel "Multiway Coil®"During the single channel treatment trial period the patients will receive the following dose of rTMS: 10 Hz - left DLPFC ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks). | Device | single channel |
| Two channels "Multiway stimulator coil®" (Brainsway Ltd.)During the two channels treatment trial period the patients will receive the following dose of rTMS: 10 Hz- left DLPFC, 1Hz - right DLPFC together. 10 Hz protocol: ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks) 1 Hz protocol: 1 Hz, at 120% MT, 5 min pulse train, 1 min inter-train interval, 6 trains, i.e. a total of 1800 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 36,000 pulses in 4 weeks). | Device | Two channels "Multiway stimulator coil®" (Brainsway Ltd.) |
Primary outcome
Clinical antidepressant response as defined by decline of HDRS-21 score over time
Time frame: 20 day
Clinical antidepressant response at the end of the treatment, defined as a decline in Hamilton depression rating scale (HDRS-21) from the baseline rating by 50%.
4 secondary outcomes
Symptomatic improvement
Time frame: day 20
Clinical antidepressant remission as defined by decline of HDRS-21 score over time
Time frame: Day 20
Symptomatic improvement
Time frame: day 20
Symptomatic improvement
Time frame: day 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
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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.
Yuval Bloch, Md, Phd principal investigator
Shalvata Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single channel "Multiway Coil®" and Two channels "Multiway stimulator coil®" (Brainsway Ltd.) in people with Depression, run by Shalvata Mental Health Center at 1 site in Israel.
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 17 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 21 Aug 2014. 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 Israel. 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.
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 Yuval Bloch, MD, Phd (097478644, yuvalbl@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical antidepressant response as defined by decline of HDRS-21 score over time (time frame: 20 day). 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 21 Aug 2014.