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Low Field Magnetic Stimulation Treatment for Bipolar Depression

This study has been terminated.
(Study was terminated for lack of recruitment.)
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Michael Rohan, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00217217
First received: September 15, 2005
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

Individuals with bipolar depression who had a particular kind of brain imaging reported improved mood after the imaging. This effect may be linked to the changing magnetic fields used during these magnetic resonance imaging studies. The current studies are designed to further explore the important parameters of this effect and to clarify the degree and duration of the mood effects.


Condition Intervention Phase
Bipolar Depression
Bipolar Disorder
Depression
 Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Field Magnetic Stimulation in Bipolar Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Positive and Negative Affect Scale [ Time Frame: pre/post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual-Analog Scales [ Time Frame: pre/post-treatment ] [ Designated as safety issue: No ]
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: September 2004
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active EEP-MRSI treatment
20 minutes of active treatment with theEcho-Planar Magnetic Resonance Imaging (EP-MRSI)
 Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)
variable-setting low-frequency MRI
Other Name: Low Field Magnetic Stimulation (LFMS)
Sham Comparator: Sham comparator EP-MRSI
Sham treatment (20 minutes) with the Echo-Planar Magnetic Resonance Imaging (EP-MRSI).
 Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)
variable-setting low-frequency MRI
Other Name: Low Field Magnetic Stimulation (LFMS)

Detailed Description:

An initial study using proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) in bipolar depressed individuals was associated with reports of improved mood. These studies employed oscillating magnetic fields similar to those used in functional MRI (fMRI), but which differ from the usual fMRI scan in field direction, waveform frequency, and strength. As the abbreviation EP-MRSI is used to describe several relatively common MR sequences, the specific potential clinical procedure being used is referred to as low field magnetic stimulation or LFMS. Following these initial results, investigators are conducting studies to determine the critical variables in both subjects and treatment for optimal response. Studies are also underway to characterize the response of specific depression symptoms, the degree of response, and the duration of response.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of bipolar disorder.
  • Current depression.

Exclusion Criteria:

  • Contraindication for MRI due to metal in eyes/head
  • Claustrophobia.
  • Inability to lie flat.
  • History of brain injury.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217217

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Stanley Medical Research Institute
Investigators
Principal Investigator: Michael Rohan, MS Mclean Hospital
  More Information

Additional Information:
Web site for McLean hospital with links to research pages.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Michael Rohan, Imaging Physicist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00217217     History of Changes
Other Study ID Numbers: 2004P-002631
Study First Received: September 15, 2005
Last Updated: March 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
non-pharmaceutical
alternative
imaging
magnetic resonance imaging
 low field magnetic stimulation
bipolar disorder
depression
bipolar depression

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

ClinicalTrials.gov processed this record on May 16, 2013