Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

Mass General Brigham

Status: Completed

Conditions: Major Depressive Disorder; Bipolar Depression; Depression

Treatments: Device: Low Field Magnetic Stimulation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT00578383

Stanley Grant 07TGS-1045 (Other Grant/Funding Number)

2006-P-001655

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 4 patient groups

Sham (inactive) Treatment BPD

Sham Comparator group

Description:

20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects

Treatment:

Device: Low Field Magnetic Stimulation Device

Active LFMS treatment in BPD

Active Comparator group

Description:

20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects

Treatment:

Device: Low Field Magnetic Stimulation Device

Sham LFMS Comparator: in MD

Sham Comparator group

Description:

20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects

Treatment:

Device: Low Field Magnetic Stimulation Device

Experimental LFMS: in MD

Active Comparator group

Description:

20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects

Treatment:

Device: Low Field Magnetic Stimulation Device