Low Field Magnetic Stimulation Treatment for Bipolar Depression

Depression Clinical Trial

Official title:

Low Field Magnetic Stimulation in Bipolar Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00217217
• Other study ID #: 2004P-002631
• Status: Terminated
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: March 13, 2012
• Start date: September 2004
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Device:
• Echo-Planar Magnetic Resonance Imaging (EP-MRSI)
variable-setting low-frequency MRI

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Affect Scale		pre/post-treatment
Secondary	Visual-Analog Scales		pre/post-treatment
Secondary	Montgomery Asberg Depression Rating Scale (MADRS)		pre-treatment

External Links

•   Web site for McLean hospital with links to research pages.