Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

This study is ongoing, but not recruiting participants.
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: September 11, 2012
Last verified: September 2012

December 18, 2007
September 11, 2012
November 2007
March 2011   (final data collection date for primary outcome measure)
  • Hamilton Depression Scale (HAM-D) (17 item) [ Time Frame: Once just before and once just after treatment ] [ Designated as safety issue: No ]
    A multiple choice questionnaire used to rate depression severity. Safety Issue?: (FDAAA)
  • Visual Analog Scale (VAS) [ Time Frame: Once just before and once just after treatment ] [ Designated as safety issue: No ]
    Ten point Likert scales indicating immediate and 24 hr depression state.
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
Positive and Negative Affect Scale (PANAS) [ Time Frame: Once just before and once just after treatment ] [ Designated as safety issue: No ]
20 item list of words with positive and negative valences (10 each), which the subject scores on a 1-5 scale.
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.
  • Sham Comparator: Sham (inactive) Treatment
    20 minutes of sham treatment with the LFMS device
    Intervention: Device: Low Field Magnetic Stimulation Device
  • Experimental: Active LFMS treatment
    20 minutes of active treatment with the LFMS device
    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.
 
Active, not recruiting
100
November 2012
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 65 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, S.M. Mclean Hospital
Mclean Hospital
September 2012

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