Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mclean Hospital
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) in Subjects With Bipolar Depression
Study Overview
Brief Summary
This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.
Detailed Description
This study involves a screening visit with the study physician and a treatment visit. Participants will be asked to complete several questionnaires about their mood during both visits. The treatment visit will involve use of the LFMS device. Participants will place the top of their head inside the device for approximately 20 minutes. Participants will receive either the actual treatment or a sham treatment and will not know which they receive. This device produces weak electromagnetic fields. There is no discomfort or even sensation caused by the device. The device has been declared to be a "non-significant risk device" by the FDA, and there are no known risks associated with its use.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed
- •May be medicated or unmedicated
Exclusion Criteria
- •Contraindication for MRI due to metal in eyes/head
- •Claustrophobia.
- •Inability to lie flat.
- •History of brain injury.
- •Current drug use/abuse/dependence
- •History of polysubstance use
Arms & Interventions
Sham (inactive) Treatment BPD
20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
Intervention: Low Field Magnetic Stimulation Device (Device)
Active LFMS treatment in BPD
20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
Intervention: Low Field Magnetic Stimulation Device (Device)
Sham LFMS Comparator: in MD
20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
Intervention: Low Field Magnetic Stimulation Device (Device)
Experimental LFMS: in MD
20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
Intervention: Low Field Magnetic Stimulation Device (Device)
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) in Subjects With Bipolar Depression
Time Frame: Once just before and once just after treatment
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder
Time Frame: Once just before and once just after treatment
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
Time Frame: Once just before and once just after treatment
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder
Time Frame: Once just before and once just after treatment
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Secondary Outcomes
- Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.(Once just before and once just after treatment)
- Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.(Once just before and once just after treatment)
- Visual Analog Scale (VAS): Combined Diagnostic Groups.(Once just before and once just after treatment)
- Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.(once pre and once post LFMS treatment)
- Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression(once pre and once post LFMS treatment)
- Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.(Once just before and once just after treatment)
- Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder(Once just before and once just after treatment)
- Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder(once pre and once post LFMS treatment)
Investigators
Michael Rohan
Imaging Physicist
Mclean Hospital