NCT01557192

Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments

Low Field Magnetic Stimulation in Mood Disorders in Six Visits

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.

Detailed description

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods. The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. This is analogous to the synaptic effects of pharmaceutical antidepressants in providing a "boost" to synapses in certain brain regions. Previous investigations of LFMS included depressed subjects with bipolar disorder. This study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar disorder and major depressive disorder.

Conditions

• Bipolar Depression
• Unipolar Depression

Interventions

Type	Name	Description
DEVICE	Low Field Magnetic Stimulation Device	The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.

Timeline

• Start date: 2010-05-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2012-03-19
• Last updated: 2016-04-13

Locations

1 site across 1 country: United States