Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

Depression Clinical Trial

— LFMS  

Official title:

Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578383
• Other study ID #: 2006-P-001655
• Secondary ID: Stanley Grant 07
• Status: Completed
• Phase: N/A
• First received: December 18, 2007
• Last updated: March 28, 2014
• Start date: November 2007
• Est. completion date: March 2013

Study information

• Verified date: March 2014
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 2013
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mood Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6. — View Citation

Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression	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.	Once just before and once just after treatment	No
Primary	Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder	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.	Once just before and once just after treatment	No
Primary	Visual Analog Scale (VAS) in Subjects With Bipolar Depression	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.	Once just before and once just after treatment	No
Primary	Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder	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.	Once just before and once just after treatment	Yes
Secondary	Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.	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.	Once just before and once just after treatment	No
Secondary	Visual Analog Scale (VAS): Combined Diagnostic Groups.	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.	Once just before and once just after treatment	No
Secondary	Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.	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.	Once just before and once just after treatment	No
Secondary	Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.	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.	once pre and once post LFMS treatment	No
Secondary	Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.	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.	Once just before and once just after treatment	No
Secondary	Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder	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.	Once just before and once just after treatment	No
Secondary	Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression	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.	once pre and once post LFMS treatment	No
Secondary	Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder	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.	once pre and once post LFMS treatment	No