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

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

This study is currently recruiting participants.

Verified March 2012 by Mclean Hospital

First Received on March 14, 2012. Last Updated on March 15, 2012 History of Changes

Sponsor:	Mclean Hospital
Information provided by (Responsible Party):	Michael Rohan, Mclean Hospital
ClinicalTrials.gov Identifier:	NCT01557192

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 I

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:

MedlinePlus related topics: Depression

U.S. FDA Resources

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

Contacts

Contact: Rinah T Yamamoto, Ph.D.

617-855-2862

yamamoto@mclean.harvard.edu

Locations

United States, Massachusetts
McLean Hospital	Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Rinah T Yamamoto, Ph.D. 617-855-2862

Sponsors and Collaborators

Mclean Hospital

Investigators

Principal Investigator:

Michael L. Rohan, Ph.D.

Mclean Hospital

More Information

Publications:

Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8.

Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6.

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:	March 15, 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 March 18, 2012

http://clinicaltrials.gov/ct2/show/NCT01557192?term=major+depressive+disorder&lup_s=02%2F19%2F2012&lup_d=30