Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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

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Depression Bipolar Depression Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sham (inactive) Treatment BPD

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

Group Type SHAM_COMPARATOR

Low Field Magnetic Stimulation Device

Intervention Type 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.

Active LFMS treatment in BPD

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

Group Type ACTIVE_COMPARATOR

Low Field Magnetic Stimulation Device

Intervention Type 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 LFMS Comparator: in MD

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

Group Type SHAM_COMPARATOR

Low Field Magnetic Stimulation Device

Intervention Type 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.

Experimental LFMS: in MD

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

Group Type ACTIVE_COMPARATOR

Low Field Magnetic Stimulation Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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LFMS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No