LFMS6tx: Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments

Sponsor

Mclean Hospital (Other)

Overall Status

Suspended

CT.gov ID

NCT01557192

Collaborator

(none)

200

Enrollment

Location

Arms

120

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bipolar Depression Unipolar Depression	Device: Low Field Magnetic Stimulation Device	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Low Field Magnetic Stimulation in Mood Disorders in Six Visits

Study Start Date :

May 1, 2010

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active LFMS treatment 20 minute exposure to the LFMS electromagnetic field treatment	Device: 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. Other Names: LFMS
Placebo Comparator: Sham LFMS treatment 20 minute exposure to either the sham (inactive) electromagnetic field treatment	Device: 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. Other Names: LFMS

Arm

Intervention/Treatment

Active Comparator: Active LFMS treatment

20 minute exposure to the LFMS electromagnetic field treatment

Device: 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.

Other Names:

LFMS

Placebo Comparator: Sham LFMS treatment

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

Device: Low Field Magnetic Stimulation Device

Other Names:

LFMS

Outcome Measures

Primary Outcome Measures

Change in Montgomery-Asberg Depression Rating Scale (MADRS)score [at baseline and at week 3]
MADRS scores will be compared between the baseline and week 3, one week after the final treatment.
Change in Positive-Negative Affect Scale (PANAS)score [at baseline and at one and at week 3]
PANAS scores will be compared between the baseline and week 3, one week after the final treatment.

Secondary Outcome Measures

Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings [at baseline and immediately before and after each treatment, 6 treatments across 2 weeks]
PANAS scores will be assessed at baseline and before and after each treatment. There are six treatments (Monday, Wednesday and Friday for two weeks).
Change in Montgomery-Asberg Depression Rating Scale (MADRS)score [at baseline and at week 4]
MADRS scores will be compared between the baseline and week 4, two weeks after the final treatment.
Change in Positive-Negative Affect Scale (PANAS)score. [at baseline and at one and at week 4]
PANAS scores will be compared between the baseline and week 4, two weeks after the final treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects MUST be significantly depressed, currently.
Subjects must not have serious physical illnesses, neurological diseases or dementias.
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.
Subject must have a Ham-D score > 17, YMRS score < 7 (bipolar subjects only), and a MADRS score > 18.
Subjects must be capable of providing informed consent.
Subjects must have an established residence and phone.
Subjects may be medicated or unmedicated.

Exclusion Criteria:

Dangerous or active suicidal ideation.
Pregnant or planning on becoming pregnant.
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).
Mixed mood state or rapid cycling.
Presence of a pacemaker, neurostimulator, or metal in head or neck.