Low Field Magnetic Stimulation Treatment for Bipolar Depression

Mass General Brigham

Status and phase: Terminated; Phase 3

Conditions: Bipolar Disorder; Bipolar Depression; Depression

Treatments: Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)

Study type: Interventional

Funder types: Other

Identifiers

NCT00217217

2004P-002631

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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13 participants in 2 patient groups

Active EEP-MRSI treatment

Experimental group

Description:

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

Treatment:

Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)

Sham comparator EP-MRSI

Sham Comparator group

Description:

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

Treatment:

Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)