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

April 12, 2016 updated by: Michael Rohan, Mclean Hospital

Low Field Magnetic Stimulation in Mood Disorders in Six Visits

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings
Time Frame: 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).
at baseline and immediately before and after each treatment, 6 treatments across 2 weeks
Change in Montgomery-Asberg Depression Rating Scale (MADRS)score
Time Frame: at baseline and at week 4
MADRS scores will be compared between the baseline and week 4, two weeks after the final treatment.
at baseline and at week 4
Change in Positive-Negative Affect Scale (PANAS)score.
Time Frame: 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.
at baseline and at one and at week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Investigators

  • Principal Investigator: Michael L. Rohan, Ph.D., McLean Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ANTICIPATED)

May 1, 2020

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

March 14, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (ESTIMATE)

March 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-P-001097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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