Low Field Magnetic Stimulation Treatment for Bipolar Depression

NCT ID: NCT00217217

Last Updated: 2012-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2012-01-31

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.

Conditions

Bipolar Depression; Bipolar Disorder; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active EEP-MRSI treatment

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

Group Type: EXPERIMENTAL

Echo-Planar Magnetic Resonance Imaging (EP-MRSI)

Intervention Type: DEVICE

variable-setting low-frequency MRI

Sham comparator EP-MRSI

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

Group Type: SHAM_COMPARATOR

Echo-Planar Magnetic Resonance Imaging (EP-MRSI)

Intervention Type: DEVICE

variable-setting low-frequency MRI

Interventions

Echo-Planar Magnetic Resonance Imaging (EP-MRSI)

variable-setting low-frequency MRI

Intervention Type: DEVICE

Other Intervention Names

Low Field Magnetic Stimulation (LFMS)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael Rohan

Imaging Physicist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Rohan, MS

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15780843 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14702256 (View on PubMed)

Other Identifiers

2004P-002631

Identifier Type: -

Identifier Source: org_study_id