NCT00578383

Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression
• Bipolar Depression
• Major Depressive Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-03-01
• Completion: 2013-03-01
• First posted: 2007-12-21
• Last updated: 2016-05-16
• Results posted: 2014-04-30

Locations

1 site across 1 country: United States