Back to resultsMultiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression (LFMS)
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Field Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Depression focused on measuring Low Field Magnetic Stimulation, bipolar, depression, alternative treatment
Eligibility Criteria
Inclusion Criteria:
- Subjects will be men or women between the ages of 21-65.
- Subjects must not have serious physical illnesses, neurological diseases or dementias.
- Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II and meet criteria for current depression (DSM-IV major depressive episode, current).
- Subject must have a MADRS >= 20, Young Mania Rating Score (YMRS score) < 7.
- Subjects must be capable of providing informed consent.
- Subjects must have an established residence and phone.
- Subjects may be medicated or unmedicated.
Exclusion Criteria:
- Dangerous or active suicidal ideation.
- Pregnant or planning on becoming pregnant.
- Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
- Mania, hypomania or mixed mood state.
- Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
- Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to enrollment.
- History of schizophrenia, schizoaffective, obsessive-compulsive or post-traumatic stress disorders.
- Treatment resistant depression (as determined by the study psychiatrist; consistently and substantially symptomatic over several years despite electroconvulsive therapy, 2 or more adequate trials of a primary mood stabilizer with antidepressant effects (e.g., lithium, valproate or lamotrigine) or antidepressant medications (e.g., bupropion, Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI).)
- Contraindications for Magnetic Resonance Imaging (MRI): Presence of a pacemaker, neurostimulator, or metal in head or neck.
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
LFMS - active treatment
LFMS - sham treatment
Arm Description
Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Outcomes
Primary Outcome Measures
Long Term Change: Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the change from pretreatment baseline acquired at the screening visit to a follow-up visit 7 days after the first treatment.
Change Over First Treatment: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale
PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. This outcome measure is the difference between the scale administered immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment.
Secondary Outcome Measures
Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale
PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three post (<30min oost treatment) minus pre (<30min pre treatment) score differences for the three treatment days
Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS)
The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days
Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale
PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days
Full Information
NCT ID
NCT01929681
First Posted
July 23, 2013
Last Updated
August 28, 2017
Sponsor
Mclean Hospital
Collaborators
The Depressive and Bipolar Disorder Alternative Treatment Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01929681
Brief Title
Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression
Acronym
LFMS
Official Title
Low Field Magnetic Stimulation in Mood Disorders: Three Daily Visits
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
The Depressive and Bipolar Disorder Alternative Treatment Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objectives:
To demonstrate the duration of the antidepressant effect of Low Field Magnetic Stimulation (LFMS)in subjects with bipolar depression.
Hypotheses:
Investigators expect subjects who receive LFMS to show significant mood improvement one week after the start of a three day course of daily stimulation as compared to subjects who receive sham LFMS.
Investigators expect subjects who receive LFMS to show immediate mood improvement over the first treatment as measured by the difference in pre and post-treatment PANAS+ ratings.
Investigators expect to show that LFMS will be well tolerated in a three-treatment protocol.
Detailed Description
Low Field Magnetic Stimulation is an electromagnetic intervention being investigated at McLean Hospital because of its effect on symptoms of depression. It consists of pulsed electric fields that are induced remotely in the head by a portable coil. It has been observed to have mood elevating effects in depressed patients with Bipolar Disorder (BPD). These effects are immediate, occurring upon completion of a 20 minute treatment.
LFMS is unique because of its low electric field strength, and because of its high frequency operation, compared to other electromagnetic treatments. While other treatments such as Electroconvulsive Therapy (ECT) use electric fields equivalent to > 100-200 Volts/meter to affect the brain, LFMS uses <1 V/m. Such a low electric field strength indicates that another mechanism is activated by LFMS, and this provides a possibility for a new treatment. It may also give insight into causes of depression.
LFMS is also unique because it has an immediate effect. This immediate effect may have implications for emergency treatment.
The purpose of this study is to observe the response to LFMS in depressed BPD subjects with the aim of assessing the effects of multiple treatments, and of observing the duration of the mood improvement.To do so, the investigators propose to study 72 subjects in a protocol of three treatments in three days. Subjects will be rated before and after each treatment, and will return for mood ratings at one week after treatment. Investigators hope that this characterization of LFMS will allow clinical research groups to perform large trials and to evaluate its clinical effectiveness in patient populations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Low Field Magnetic Stimulation, bipolar, depression, alternative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LFMS - active treatment
Arm Type
Experimental
Arm Description
Low Field Magnetic Stimulation (LFMS) active treatment
Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Arm Title
LFMS - sham treatment
Arm Type
Sham Comparator
Arm Description
Low Field Magnetic Stimulation - sham treatment
Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Intervention Type
Device
Intervention Name(s)
Low Field Magnetic Stimulation
Other Intervention Name(s)
LFMS
Intervention Description
Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Primary Outcome Measure Information:
Title
Long Term Change: Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the change from pretreatment baseline acquired at the screening visit to a follow-up visit 7 days after the first treatment.
Time Frame
Variable based on screening visit schedule, > 2 weeks.
Title
Change Over First Treatment: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale
Description
PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. This outcome measure is the difference between the scale administered immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment.
Time Frame
90 minutes; change immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment.
Secondary Outcome Measure Information:
Title
Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale
Description
PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three post (<30min oost treatment) minus pre (<30min pre treatment) score differences for the three treatment days
Time Frame
Over 3 days of treatment
Title
Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS)
Description
The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days
Time Frame
Over 3 days of treatment
Title
Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale
Description
PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days
Time Frame
Over 3 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will be men or women between the ages of 21-65.
Subjects must not have serious physical illnesses, neurological diseases or dementias.
Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II and meet criteria for current depression (DSM-IV major depressive episode, current).
Subject must have a MADRS >= 20, Young Mania Rating Score (YMRS score) < 7.
Subjects must be capable of providing informed consent.
Subjects must have an established residence and phone.
Subjects may be medicated or unmedicated.
Exclusion Criteria:
Dangerous or active suicidal ideation.
Pregnant or planning on becoming pregnant.
Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
Mania, hypomania or mixed mood state.
Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to enrollment.
History of schizophrenia, schizoaffective, obsessive-compulsive or post-traumatic stress disorders.
Treatment resistant depression (as determined by the study psychiatrist; consistently and substantially symptomatic over several years despite electroconvulsive therapy, 2 or more adequate trials of a primary mood stabilizer with antidepressant effects (e.g., lithium, valproate or lamotrigine) or antidepressant medications (e.g., bupropion, Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI).)
Contraindications for Magnetic Resonance Imaging (MRI): Presence of a pacemaker, neurostimulator, or metal in head or neck.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Rohan, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression
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