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

This study has suspended participant recruitment.
(on hold indefinitely due to lack of funding)
Sponsor:
Information provided by (Responsible Party):
Michael Rohan, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01557192
First received: March 14, 2012
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Bipolar Depression
Unipolar Depression
Device: Low Field Magnetic Stimulation Device
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Field Magnetic Stimulation in Mood Disorders in Six Visits

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Change in Montgomery-Asberg Depression Rating Scale (MADRS)score [ Time Frame: at baseline and at week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: at baseline and at one and at week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: at baseline and immediately before and after each treatment, 6 treatments across 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: at baseline and at week 4 ] [ Designated as safety issue: No ]
    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. [ Time Frame: at baseline and at one and at week 4 ] [ Designated as safety issue: No ]
    PANAS scores will be compared between the baseline and week 4, two weeks after the final treatment.


Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: LFMS

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557192

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Michael L. Rohan, Ph.D. Mclean Hospital
  More Information

Publications:
Responsible Party: Michael Rohan, Imaging Physicist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01557192     History of Changes
Other Study ID Numbers: 2010-P-001097
Study First Received: March 14, 2012
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Depression
Bipolar Depression
LFMS
Electromagnetic Stimulation

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014