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Low Field Magnetic Stimulation Treatment for Bipolar Depression

Primary Purpose

Bipolar Depression, Bipolar Disorder, Depression

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Echo-Planar Magnetic Resonance Imaging (EP-MRSI)

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring non-pharmaceutical, alternative, imaging, magnetic resonance imaging, low field magnetic stimulation, bipolar disorder, depression, bipolar depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active EEP-MRSI treatment

Sham comparator EP-MRSI

Arm Description

20 minutes of active treatment with theEcho-Planar Magnetic Resonance Imaging (EP-MRSI)

Sham treatment (20 minutes) with the Echo-Planar Magnetic Resonance Imaging (EP-MRSI).

Outcomes

Primary Outcome Measures

Positive and Negative Affect Scale

Secondary Outcome Measures

Visual-Analog Scales

Montgomery Asberg Depression Rating Scale (MADRS)

Full Information

NCT ID

NCT00217217

First Posted

September 15, 2005

Last Updated

March 13, 2012

Sponsor

Mclean Hospital

Collaborators

Stanley Medical Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00217217

Brief Title

Low Field Magnetic Stimulation Treatment for Bipolar Depression

Official Title

Low Field Magnetic Stimulation in Bipolar Depression

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated for lack of recruitment.

Study Start Date

September 2004 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mclean Hospital

Collaborators

Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Depression, Bipolar Disorder, Depression

Keywords

non-pharmaceutical, alternative, imaging, magnetic resonance imaging, low field magnetic stimulation, bipolar disorder, depression, bipolar depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active EEP-MRSI treatment

Arm Type

Experimental

Arm Description

20 minutes of active treatment with theEcho-Planar Magnetic Resonance Imaging (EP-MRSI)

Arm Title

Sham comparator EP-MRSI

Arm Type

Sham Comparator

Arm Description

Sham treatment (20 minutes) with the Echo-Planar Magnetic Resonance Imaging (EP-MRSI).

Intervention Type

Device

Intervention Name(s)

Echo-Planar Magnetic Resonance Imaging (EP-MRSI)

Other Intervention Name(s)

Low Field Magnetic Stimulation (LFMS)

Intervention Description

variable-setting low-frequency MRI

Primary Outcome Measure Information:

Title

Positive and Negative Affect Scale

Time Frame

pre/post-treatment

Secondary Outcome Measure Information:

Title

Visual-Analog Scales

Time Frame

pre/post-treatment

Title

Montgomery Asberg Depression Rating Scale (MADRS)

Time Frame

pre-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Rohan, MS

Organizational Affiliation

Mclean Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

McLean Hospital

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15780843

Citation

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. doi: 10.1016/j.biopsych.2004.12.011.

Results Reference

background

PubMed Identifier

14702256

Citation

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. doi: 10.1176/appi.ajp.161.1.93.

Results Reference

result

Links:

URL

http://www.mclean.org

Description

Web site for McLean hospital with links to research pages.

Learn more about this trial

Low Field Magnetic Stimulation Treatment for Bipolar Depression

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