Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Michael Rohan, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00578383
First received: December 18, 2007
Last updated: March 28, 2014
Last verified: March 2014

December 18, 2007
March 28, 2014
November 2007
March 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Visual Analog Scale (VAS) in Subjects With Bipolar Depression [ Time Frame: Once just before and once just after treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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) rating scores [ Time Frame: Immediately before and after treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00578383 on ClinicalTrials.gov Archive Site
  • Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups. [ Time Frame: Once just before and once just after treatment ] [ Designated as safety issue: No ]
    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.
  • Visual Analog Scale (VAS): Combined Diagnostic Groups. [ Time Frame: Once just before and once just after treatment ] [ Designated as safety issue: No ]
    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.
  • Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group. [ Time Frame: Once just before and once just after treatment ] [ Designated as safety issue: No ]
    20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 0-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
  • Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group. [ Time Frame: once pre and once post LFMS treatment ] [ Designated as safety issue: No ]
    20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 0-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
  • Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression. [ Time Frame: Once just before and once just after treatment ] [ Designated as safety issue: No ]
    20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 0-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
  • Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder [ Time Frame: Once just before and once just after treatment ] [ Designated as safety issue: No ]
    20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 0-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
  • Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression [ Time Frame: once pre and once post LFMS treatment ] [ Designated as safety issue: No ]
    20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 0-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
  • Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder [ Time Frame: once pre and once post LFMS treatment ] [ Designated as safety issue: No ]
    20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 0-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Positive and Negative Affect Scale (PANAS) scores [ Time Frame: Immediately before and after treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device
Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Bipolar Depression
  • Major Depressive Disorder
Device: Low Field Magnetic Stimulation Device
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.
Other Name: LFMS
  • Sham Comparator: Sham (inactive) Treatment BPD
    20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
    Intervention: Device: Low Field Magnetic Stimulation Device
  • Active Comparator: Active LFMS treatment in BPD
    20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
    Intervention: Device: Low Field Magnetic Stimulation Device
  • Sham Comparator: Sham LFMS Comparator: in MD
    20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
    Intervention: Device: Low Field Magnetic Stimulation Device
  • Active Comparator: Experimental LFMS: in MD
    20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
    Intervention: Device: Low Field Magnetic Stimulation Device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
March 2013
March 2011   (final data collection date for primary outcome measure)

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.
  • Pregnant
  • Current drug use/abuse/dependence
  • History of polysubstance use
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00578383
2006-P-001655, Stanley Grant 07TGS-1045
No
Michael Rohan, Mclean Hospital
Mclean Hospital
Stanley Medical Research Institute
Principal Investigator: Michael Rohan, PhD Mclean Hospital
Mclean Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP