Treatment Resistant DepressionNCT01944644
Low Field Magnetic Stimulation for Treatment Resistant Depression
A study testing Active Low Field Magnetic Stimulation in people with Treatment Resistant Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a double-blind, randomized, sham-controlled phase II study of the effects of Low Field Magnetic Stimulation (LFMS) on brain circuitry of adults with treatment-resistant Major Depressive Disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Active Low Field Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must be able to understand and read English and give written informed consent prior to the protocol required procedures.
- Men and women, ages 18 to 65 inclusive with a diagnosis of major depressive episode as defined by DSM-IV-TR criteria.
- History of an inadequate response to 1 or more adequate antidepressant treatments in the current depressive episode.
- Subjects must have a 17-item Hamilton Rating Scale for Depression (HAM-D-17) score ≥ 18.
- Subjects must have a Body Mass Index (BMI) of approximately 18-40 kg/m².
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and must have a negative urine pregnancy test within 72 hours prior to the start of LFMS.
Who cannot join
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
- Women who are pregnant or breastfeeding.
- Subjects with other DSM-IV-TR Axis I disorders other than Generalized Anxiety Disorder (GAD: 300.02), Social Anxiety Disorder (300.23), or Specific Phobia (300.29). Subjects with co-morbid GAD, Social Anxiety Disorder, or Specific Phobia are ineligible if the co-morbid condition is clinically unstable, requires treatment, or has been the primary focus of treatment within the 6 month period prior to screening.
- Delirium, dementia, or other cognitive disorder
- Schizophrenia or other psychotic disorder, based on the MINI.
- Patients with a clinically significant Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
Show all 20Show fewer
- Patients experiencing hallucinations, delusions, or any psychotic symptomatology in the current or any previous depressive episode.
- Patients who have met DSM-IV-TR criteria for any significant substance use disorder within the past six months.
- Patients receiving new-onset psychotherapy and/or somatic therapy (light therapy, transcranial magnetic stimulation) within 6 weeks of screening, or at any time during participation in the trial.
- Patients who, in the opinion of the Investigator, are actively suicidal and at significant risk for suicide.
- Patients who have participated in any clinical trial with an investigational drug or device within the past month.
- Patients who have received ECT in the past 20 years or Vagal Nerve/Deep Brain Stimulation during their lifetime.
- Unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
- Subjects with evidence or history of significant neurological disorder, including head trauma with loss of consciousness, history of stroke, Parkinson's disease, epilepsy disorder, conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), who are taking medications to control seizures, or who have increased risk of seizures as evidenced by history of EEG with epileptiform activity (with the exception of juvenile febrile seizures).
- Patients with thyroid pathology (unless condition has been stabilized with medications for at least the past three months).
- Patients who have recently (within two weeks) begun any medications.
- Monoamine oxidase inhibitors (e.g., Nardil, phenelzine, Parnate, tranylcypromine, Marplan, isocarboxazide) treatment within the 2 weeks prior to enrollment.
- Patients with a history of antidepressant-induced hypomania or dysphoria.
- Participants with metal implants (Will use the NY Presbyterian Hospital MRI Checklist)
- Any of the following exclusion criteria for MRI Cardiac pacemaker or pacing wires Implanted cardioverter defibrillator (ICD) Cochlear, otologic, or other ear implant Tissue expander (e.g., breast) Implanted drug infusion device Aneurysm clip(s) Deep Brain Stimulator Other Neuro-stimulator Prosthesis (eye, penile, limb, etc.) Artificial heart valve Eyelid spring or wire Stent, filter, or coil Programmable shunt Catheter or feeding tube with metal tip Radiation seeds Medication patch (Nicotine, Nitroglycerine) Any metallic fragment, foreign body or bullets Surgical staples, clips, metallic sutures or wire mesh Bone/joint pin, screw, nail, wire, plate, etc. IUD, diaphragm, or pessary Dentures or braces Tattoo, permanent makeup or body piercing jewelry Hearing aid (Remove before entering the MR system room) Breathing problem and motion disorder Claustrophobia Hair Extensions
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: The Effect of Low Field Magnetic Stimulation on Resting State Networks in Major Depressive Disorder
This is a double-blind, randomized, sham-controlled phase II study of the effects of Low Field Magnetic Stimulation (LFMS) on brain circuitry of adults with treatment-resistant Major Depressive Disorder (MDD). Eligible subjects will be randomly assigned to double-blind treatment with three 20 minute sessions of either (1) active LFMS or (2) sham LFMS. Resting state fMRI will be performed at baseline and following the third and final treatment session.
Read the detailed description
A minimum of 60 subjects will enter the double-blind treatment phase of the study. This trial will be conducted according to the U.S. Food and Drug Administration guidelines and the Declaration of Helsinki. Written informed consent will be obtained from all patients before protocol-specified procedures are carried out. The subjects will be drawn from an outpatient sample of patients with current Major Depressive Disorder (MDD) diagnosed with the use of the Mini International Neuropsychiatric Interview (MINI).
LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). LFMS treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain. Sham LFMS will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
At the beginning of a treatment session, the subject will sit in front of and position his head within the open bore of the Tal Medical LFMS device. The device will be pre-programmed to deliver active or sham treatment so that the subject, operator, and all investigators are blinded to active treatment vs. sham. Immediately before and after each treatment session, the PANAS, Ham-D-6, and Visual Analog Mood Scale will be administered and the patient will be monitored for any adverse events.
All participants will undergo two sessions of neuroimaging: On the Friday prior to the first treatment session (Day 0) and on the day of the third and final treatment session (Day 7). Each session of neuroimaging will be 50 minutes in duration and include three imaging modalities: Resting State fMRI (rsfMRI), Arterial Spin Labeling MRI (ASL), and Diffusion Tensor Imaging (DTI). In addition, we will obtain high-resolution anatomical volumes (SPGR) for each subject for the purpose of transforming each individual's imaging data into a common space for group comparisons. Subjects will lie still in the scanner and will be instructed to let their mind "wander freely" during the acquisition of the resting state fMRI scan, which will last 6 minutes (Anon 2001). They will also be instructed to lie still during the ASL and DTI scans (each lasting 8 minutes). In addition, we will obtain a high-resolution T1-weighted (MP-RAGE) anatomical scan for co-registration of each individual's imaging data into a common space for group statistics..
Resting state fMRI will be used to measure the functional connectivity within the default mode network (DMN) and other circuits that are known to function abnormally in MDD (Greicius et al. 2007). ASL will be used to measure the regional blood flow within individual nodes of this circuitry, while DTI will measure the structural integrity of the connections between nodes. Measurements at baseline will be compared to measurements post-LFMS in both active treatment and sham groups.
- Conditions
- Treatment Resistant Depression
- Being tested
- Active Low Field Magnetic Stimulation, Sham Low Field Magnetic Stimulation
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Low Field Magnetic StimulationDevice
Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
Sham Low Field Magnetic StimulationDevice
Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Active Low Field Magnetic Stimulation | Active comparator | LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain. Receives: Device: Active Low Field Magnetic Stimulation |
| Sham Low Field Magnetic Stimulation | Sham comparator | Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment. Receives: Device: Sham Low Field Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Item Hamilton Depression Rating Scale
This is to compare the 6 Item Hamilton Depression Rating Scale from the Screen to after 3 Sessions of Active or Sham LFMS (7 days post-baseline). The Hamilton Scale for Depression 6 item subscale scores range from 0-24. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Measured: 7 days after baseline
Visual Analog Scale
A Visual Analog Scale is a measurement of subjective characteristics that cannot be directly measured. Using this self questionnaire, subjects specify their level of depression along a continuous line between two end-points ranging from 0-100 (higher score means better mood).
Measured: 7 days after baseline
Positive and Negative Affect Score (PANAS) - Negative Subscale
The Positive and Negative Affect Schedule (PANAS) measures both positive affect and negative affect. Participants in the PANAS are required to respond to two 20-item subscales using 5-point scale that ranges from very slightly or not at all (1) to extremely (5). This negative subscale captures self-rated scale of symptoms of depression ranging from 0-50 (higher score means worse depression).
Measured: 7 days after baseline
Positive and Negative Affect Score (PANAS) - Positive Subscale
The Positive and Negative Affect Schedule (PANAS) measures both positive affect and negative affect. Participants in the PANAS are required to respond to two 20-item subscales using 5-point scale that ranges from very slightly or not at all (1) to extremely (5). This positive subscale captures self-rated scale of symptoms of depression ranging from 0-50 (higher score means worse depression).
Measured: 7 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Dubin, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944644
- Sponsor's protocol ID
- 1207012777
- Other IDs
- 1207012777
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2013
- Last updated
- 17 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Participants will be able to find out which treatment arm they were assigned at the conclusion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Field Magnetic Stimulation on Resting State Networks in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01944644
- Acronym / sponsor ID
- 1207012777
- Conditions
- Treatment Resistant Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 17 Sep 2018
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 double-blind, randomized, sham-controlled phase II study of the effects of Low Field Magnetic Stimulation (LFMS) on brain circuitry of adults with treatment-resistant Major Depressive Disorder (MDD). Eligible subjects will be randomly assigned to double-blind treatment with three 20 minute sessions of either (1) active LFMS or (2) sham LFMS. Resting state fMRI will be performed at baseline and following the third and final treatment session.
Detailed description
A minimum of 60 subjects will enter the double-blind treatment phase of the study. This trial will be conducted according to the U.S. Food and Drug Administration guidelines and the Declaration of Helsinki. Written informed consent will be obtained from all patients before protocol-specified procedures are carried out. The subjects will be drawn from an outpatient sample of patients with current Major Depressive Disorder (MDD) diagnosed with the use of the Mini International Neuropsychiatric Interview (MINI).
LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). LFMS treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain. Sham LFMS will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
At the beginning of a treatment session, the subject will sit in front of and position his head within the open bore of the Tal Medical LFMS device. The device will be pre-programmed to deliver active or sham treatment so that the subject, operator, and all investigators are blinded to active treatment vs. sham. Immediately before and after each treatment session, the PANAS, Ham-D-6, and Visual Analog Mood Scale will be administered and the patient will be monitored for any adverse events.
All participants will undergo two sessions of neuroimaging: On the Friday prior to the first treatment session (Day 0) and on the day of the third and final treatment session (Day 7). Each session of neuroimaging will be 50 minutes in duration and include three imaging modalities: Resting State fMRI (rsfMRI), Arterial Spin Labeling MRI (ASL), and Diffusion Tensor Imaging (DTI). In addition, we will obtain high-resolution anatomical volumes (SPGR) for each subject for the purpose of transforming each individual's imaging data into a common space for group comparisons. Subjects will lie still in the scanner and will be instructed to let their mind "wander freely" during the acquisition of the resting state fMRI scan, which will last 6 minutes (Anon 2001). They will also be instructed to lie still during the ASL and DTI scans (each lasting 8 minutes). In addition, we will obtain a high-resolution T1-weighted (MP-RAGE) anatomical scan for co-registration of each individual's imaging data into a common space for group statistics..
Resting state fMRI will be used to measure the functional connectivity within the default mode network (DMN) and other circuits that are known to function abnormally in MDD (Greicius et al. 2007). ASL will be used to measure the regional blood flow within individual nodes of this circuitry, while DTI will measure the structural integrity of the connections between nodes. Measurements at baseline will be compared to measurements post-LFMS in both active treatment and sham groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Low Field Magnetic Stimulation | Active comparator | Device: Active Low Field Magnetic StimulationLFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain. |
| Sham Low Field Magnetic Stimulation | Sham comparator | Device: Sham Low Field Magnetic StimulationSham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be able to understand and read English and give written informed consent prior to the protocol required procedures.
- Men and women, ages 18 to 65 inclusive with a diagnosis of major depressive episode as defined by DSM-IV-TR criteria.
- History of an inadequate response to 1 or more adequate antidepressant treatments in the current depressive episode.
- Subjects must have a 17-item Hamilton Rating Scale for Depression (HAM-D-17) score ≥ 18.
- Subjects must have a Body Mass Index (BMI) of approximately 18-40 kg/m².
Key exclusion criteria (20 listed)
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
- Women who are pregnant or breastfeeding.
- Subjects with other DSM-IV-TR Axis I disorders other than Generalized Anxiety Disorder (GAD: 300.02), Social Anxiety Disorder (300.23), or Specific Phobia (300.29). Subjects with co-morbid GAD, Social Anxiety Disorder, or Specific Phobia are ineligible if the co-morbid condition is clinically unstable, requires treatment, or has been the primary focus of treatment within the 6 month period prior to screening.
- Delirium, dementia, or other cognitive disorder
- Schizophrenia or other psychotic disorder, based on the MINI.
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 |
|---|---|---|
| Active Low Field Magnetic StimulationActive Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain. | Device | Active Low Field Magnetic Stimulation |
| Sham Low Field Magnetic StimulationSham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment. | Device | Sham Low Field Magnetic Stimulation |
Primary outcome
6 Item Hamilton Depression Rating Scale
Time frame: 7 days after baseline
This is to compare the 6 Item Hamilton Depression Rating Scale from the Screen to after 3 Sessions of Active or Sham LFMS (7 days post-baseline). The Hamilton Scale for Depression 6 item subscale scores range from 0-24. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Visual Analog Scale
Time frame: 7 days after baseline
A Visual Analog Scale is a measurement of subjective characteristics that cannot be directly measured. Using this self questionnaire, subjects specify their level of depression along a continuous line between two end-points ranging from 0-100 (higher score means better mood).
Positive and Negative Affect Score (PANAS) - Negative Subscale
Time frame: 7 days after baseline
The Positive and Negative Affect Schedule (PANAS) measures both positive affect and negative affect. Participants in the PANAS are required to respond to two 20-item subscales using 5-point scale that ranges from very slightly or not at all (1) to extremely (5). This negative subscale captures self-rated scale of symptoms of depression ranging from 0-50 (higher score means worse depression).
Positive and Negative Affect Score (PANAS) - Positive Subscale
Time frame: 7 days after baseline
The Positive and Negative Affect Schedule (PANAS) measures both positive affect and negative affect. Participants in the PANAS are required to respond to two 20-item subscales using 5-point scale that ranges from very slightly or not at all (1) to extremely (5). This positive subscale captures self-rated scale of symptoms of depression ranging from 0-50 (higher score means worse depression).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Participants will be able to find out which treatment arm they were assigned at the conclusion of the study.
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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.
Marc Dubin, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Low Field Magnetic Stimulation in people with Treatment Resistant Depression, run by Weill Medical College of Cornell 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 6 inclusion and 20 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 17 Sep 2018. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
6 Item Hamilton Depression Rating Scale (time frame: 7 days after baseline). The study lists 4 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 17 Sep 2018.