Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2020-05-31

Brief Summary

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To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.

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Detailed Description

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The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods.

The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. This is analogous to the synaptic effects of pharmaceutical antidepressants in providing a "boost" to synapses in certain brain regions.

Previous investigations of LFMS included depressed subjects with bipolar disorder. This study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar disorder and major depressive disorder.

Conditions

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Bipolar Depression Unipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active LFMS treatment

20 minute exposure to the LFMS electromagnetic field treatment

Group Type ACTIVE_COMPARATOR

Low Field Magnetic Stimulation Device

Intervention Type DEVICE

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.

Sham LFMS treatment

20 minute exposure to either the sham (inactive) electromagnetic field treatment

Group Type PLACEBO_COMPARATOR

Low Field Magnetic Stimulation Device

Intervention Type DEVICE

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.

Interventions

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Low Field Magnetic Stimulation Device

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.

Intervention Type DEVICE

Other Intervention Names

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LFMS

Eligibility Criteria

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Inclusion Criteria

1. Subjects MUST be significantly depressed, currently.
2. Subjects must not have serious physical illnesses, neurological diseases or dementias.
3. Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II, Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder, and be currently depressed.
4. Subject must have a Ham-D score \> 17, YMRS score \< 7 (bipolar subjects only), and a MADRS score \> 18.
5. Subjects must be capable of providing informed consent.
6. Subjects must have an established residence and phone.
7. Subjects may be medicated or unmedicated.

Exclusion Criteria

1. Dangerous or active suicidal ideation.
2. Pregnant or planning on becoming pregnant.
3. Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
4. Mixed mood state or rapid cycling.
5. Presence of a pacemaker, neurostimulator, or metal in head or neck.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No