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
  Purpose

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.


Condition Intervention
Depression
Bipolar Depression
Major Depressive Disorder
Device: Low Field Magnetic Stimulation Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 107
Study Start Date: November 2007
Study Completion Date: March 2013
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham (inactive) Treatment BPD
20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
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
Active Comparator: Active LFMS treatment in BPD
20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
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 LFMS Comparator: in MD
20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
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
Active Comparator: Experimental LFMS: in MD
20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578383

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Stanley Medical Research Institute
Investigators
Principal Investigator: Michael Rohan, PhD Mclean Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Rohan, Imaging Physicist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00578383     History of Changes
Other Study ID Numbers: 2006-P-001655, Stanley Grant 07TGS-1045
Study First Received: December 18, 2007
Results First Received: October 9, 2013
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mclean Hospital:
Depression
Major depression
Bipolar Disorder
Bipolar depression
LFMS
low field magnetic stimulation
mood disorders
affective disorders

Additional relevant MeSH terms:
Depression
Depressive Disorder
Disease
Depressive Disorder, Major
Bipolar Disorder
Mood Disorders
Behavioral Symptoms
Mental Disorders
Pathologic Processes
Affective Disorders, Psychotic

ClinicalTrials.gov processed this record on September 18, 2014