Low Field Magnetic Stimulation Treatment for Bipolar Depression

Phase 3

Terminated

• Conditions: Bipolar Depression; Bipolar Disorder; Depression
• Interventions: Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)

• Registration Number: NCT00217217
• Lead Sponsor: Mclean Hospital

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-22
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Active EEP-MRSI treatment	Echo-Planar Magnetic Resonance Imaging (EP-MRSI)	20 minutes of active treatment with theEcho-Planar Magnetic Resonance Imaging (EP-MRSI)
Sham comparator EP-MRSI	Echo-Planar Magnetic Resonance Imaging (EP-MRSI)	Sham treatment (20 minutes) with the Echo-Planar Magnetic Resonance Imaging (EP-MRSI).

Primary Outcome Measures

Name	Time	Method
Positive and Negative Affect Scale	pre/post-treatment

Secondary Outcome Measures

Name	Time	Method
Visual-Analog Scales	pre/post-treatment
Montgomery Asberg Depression Rating Scale (MADRS)	pre-treatment

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States