Low Field Magnetic Stimulation Treatment for Bipolar Depression

March 13, 2012 updated by: Michael Rohan, Mclean Hospital

Low Field Magnetic Stimulation in Bipolar Depression

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Low Field Magnetic Stimulation (LFMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive and Negative Affect Scale
Time Frame: pre/post-treatment
pre/post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual-Analog Scales
Time Frame: pre/post-treatment
pre/post-treatment
Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: pre-treatment
pre-treatment

Collaborators and Investigators

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

Sponsor

Mclean Hospital

Collaborators

Stanley Medical Research Institute

Investigators

  • Principal Investigator: Michael Rohan, MS, 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

Helpful Links

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

September 1, 2004

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004P-002631

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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