Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression (LFMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mclean Hospital
Sponsor:
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Information provided by (Responsible Party):
Michael Rohan, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01929681
First received: July 23, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

Objectives:

To demonstrate the duration of the antidepressant effect of Low Field Magnetic Stimulation (LFMS)in subjects with bipolar depression.

Hypotheses:

Investigators expect subjects who receive LFMS to show significant mood improvement one week after the start of a three day course of daily stimulation as compared to subjects who receive sham LFMS.

Investigators expect subjects who receive LFMS to show immediate mood improvement over the first treatment as measured by the difference in pre and post-treatment PANAS+ ratings.

Investigators expect to show that LFMS will be well tolerated in a three-treatment protocol.


Condition Intervention Phase
Bipolar Depression
Device: Low Field Magnetic Stimulation
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Sustained mood improvement - Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Change in MADRS scores from pretreatment to one week after initial treatment. ] [ Designated as safety issue: No ]
    Montgomery-Åsberg Depression Rating Scale (MADRS) (10 item structured interview).

  • Immediate mood improvement - Positive and Negative Affect Score (PANAS) (20 item self-report - less than 10 minutes) [ Time Frame: Change in PANAS positive score. Measured before and after first LFMS treatment ] [ Designated as safety issue: No ]
    PANAS consists of 10 positively and 10 negatively valenced word items. Items are rated by the participant for the extent they are feeling this "right now" on a scale of 1- slightly or not at all through 5- extremely.


Secondary Outcome Measures:
  • Within day, day to day mood improvement: PANAS positive difference score [ Time Frame: Change in daily PANAS positive difference score; measured twice each day on the three treatment days - pre to post LFMS treatment on each of the 3 consecutive treatment days ] [ Designated as safety issue: No ]
    PANAS scores are assessed before and after each LFMS treatment: Daily difference pre to post treatment. Change in the PANAS difference scores from first treatment, second treatment and third treatment day (repeated measure 3 scores)

  • Day to day change in pre-treatment mood - MADRS [ Time Frame: Change in MADRS scores assessed daily across pre LFMS treatment; measured pre LFMS treatment on the 3 consecutive treatment days ] [ Designated as safety issue: No ]
    MADRS scores are assessed before each LFMS treatment. Change in pre LFMS treatment score from first treatment, second treatment and third treatment day (repeated measure 3 scores)

  • Day to day change in pre treatment PANAS positive score [ Time Frame: Change in PANAS positive scores assessed daily across pre LFMS treatment; measured pre LFMS treatment on the 3 consecutive treatment days ] [ Designated as safety issue: No ]
    PANAS scores are assessed before each LFMS treatment. Change in pre LFMS treatment score score from first treatment, second treatment and third treatment day (repeated measure 3 scores)


Estimated Enrollment: 72
Study Start Date: July 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LFMS - active treatment

Low Field Magnetic Stimulation (LFMS) active treatment

Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.

Device: Low Field Magnetic Stimulation
Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Other Name: LFMS
Sham Comparator: LFMS - sham treatment

Low Field Magnetic Stimulation - sham treatment

Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.

Device: Low Field Magnetic Stimulation
Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Other Name: LFMS

Detailed Description:

Low Field Magnetic Stimulation is an electromagnetic intervention being investigated at McLean Hospital because of its effect on symptoms of depression. It consists of pulsed electric fields that are induced remotely in the head by a portable coil. It has been observed to have mood elevating effects in depressed patients with Bipolar Disorder (BPD). These effects are immediate, occurring upon completion of a 20 minute treatment.

LFMS is unique because of its low electric field strength, and because of its high frequency operation, compared to other electromagnetic treatments. While other treatments such as Electroconvulsive Therapy (ECT) use electric fields equivalent to > 100-200 Volts/meter to affect the brain, LFMS uses <1 V/m. Such a low electric field strength indicates that another mechanism is activated by LFMS, and this provides a possibility for a new treatment. It may also give insight into causes of depression.

LFMS is also unique because it has an immediate effect. This immediate effect may have implications for emergency treatment.

The purpose of this study is to observe the response to LFMS in depressed BPD subjects with the aim of assessing the effects of multiple treatments, and of observing the duration of the mood improvement.To do so, the investigators propose to study 72 subjects in a protocol of three treatments in three days. Subjects will be rated before and after each treatment, and will return for mood ratings at one week after treatment. Investigators hope that this characterization of LFMS will allow clinical research groups to perform large trials and to evaluate its clinical effectiveness in patient populations.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects will be men or women between the ages of 21-65.
  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 and meet criteria for current depression (DSM-IV major depressive episode, current).
  4. Subject must have a HDRS score > 16, Young Mania Rating Score (YMRS score) < 7.
  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. Mania, hypomania or mixed mood state.
  5. Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
  6. Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to enrollment.
  7. History of schizophrenia, schizoaffective, obsessive-compulsive or post-traumatic stress disorders.
  8. Treatment resistant depression (as determined by the study psychiatrist; consistently and substantially symptomatic over several years despite electroconvulsive therapy, 2 or more adequate trials of a primary mood stabilizer with antidepressant effects (e.g., lithium, valproate or lamotrigine) or antidepressant medications (e.g., bupropion, Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI).)
  9. Contraindications for Magnetic Resonance Imaging (MRI): Presence of a pacemaker, neurostimulator, or metal in head or neck.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929681

Contacts
Contact: Rinah T Yamamoto, Ph.D. 617-855-2862 yamamoto@mclean.harvard.edu
Contact: Sierra Fuller 617-855-4433 sfuller@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Rinah T Yamamoto, Ph.D.    617-855-2862    yamamoto@mclean.harvard.edu   
Principal Investigator: Michael L Rohan, Ph.D.         
Sponsors and Collaborators
Mclean Hospital
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Investigators
Principal Investigator: Michael L Rohan, PhD Mclean Hospital
  More Information

No publications provided

Responsible Party: Michael Rohan, Imaging Physicist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01929681     History of Changes
Other Study ID Numbers: 2012P002380
Study First Received: July 23, 2013
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Low Field Magnetic Stimulation
bipolar
depression
alternative treatment

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

ClinicalTrials.gov processed this record on October 23, 2014