NCT02542475

Low Field Magnetic Stimulation: Open Label Study.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the effects of daily LFMS treatments for those suffering from affective or anxiety symptoms. We hypothesize a reduction in affective and or anxiety symptoms after active treatment over the period of one week, with improvement through the following week.

Detailed description

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain. 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. LFMS electromagnetic fields are significantly weaker (\< 100x) than those used in ECT and rTMS. LFMS was discovered at McLean Hospital and has thus far been studied as an experimental antidepressant treatment at McLean Hospital. LFMS is also being studied at Massachusetts General Hospital and 5 other hospitals in an NIH sponsored trial (RAPID) as well as in studies at Cornell-Weill School of Medicine. The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an interaction between the electromagnetic fields and neurons in cortical regions, brought about by low level electrical stimulation applied with particular timing. The current study proposes to assess the effects of daily LFMS treatments in participants suffering from affective disorders and/or anxiety. This is an open-label study. All subjects will receive active LFMS treatments. Potential subjects will be referred to the study by their clinicians and will be pre-screened by phone.

Conditions

• Mood Disorders
• Anxiety

Interventions

Type	Name	Description
DEVICE	Low Field Magnetic Stimulation	The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain. 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. LFMS electromagnetic fields are significantly weaker (\< 100x) than those used in ECT and rTMS.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-08-01
• Completion: 2020-08-01
• First posted: 2015-09-07
• Last updated: 2016-04-13

Locations

1 site across 1 country: United States