NCT01929681

Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression

Low Field Magnetic Stimulation in Mood Disorders: Three Daily Visits

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Objectives: To demonstrate the duration of the antidepressant effect of Low Field Magnetic Stimulation (LFMS)in subjects with bipolar depression. Hypotheses: Investigators expect subjects who receive LFMS to show significant mood improvement one week after the start of a three day course of daily stimulation as compared to subjects who receive sham LFMS. Investigators expect subjects who receive LFMS to show immediate mood improvement over the first treatment as measured by the difference in pre and post-treatment PANAS+ ratings. Investigators expect to show that LFMS will be well tolerated in a three-treatment protocol.

Detailed description

Low Field Magnetic Stimulation is an electromagnetic intervention being investigated at McLean Hospital because of its effect on symptoms of depression. It consists of pulsed electric fields that are induced remotely in the head by a portable coil. It has been observed to have mood elevating effects in depressed patients with Bipolar Disorder (BPD). These effects are immediate, occurring upon completion of a 20 minute treatment. LFMS is unique because of its low electric field strength, and because of its high frequency operation, compared to other electromagnetic treatments. While other treatments such as Electroconvulsive Therapy (ECT) use electric fields equivalent to \> 100-200 Volts/meter to affect the brain, LFMS uses \<1 V/m. Such a low electric field strength indicates that another mechanism is activated by LFMS, and this provides a possibility for a new treatment. It may also give insight into causes of depression. LFMS is also unique because it has an immediate effect. This immediate effect may have implications for emergency treatment. The purpose of this study is to observe the response to LFMS in depressed BPD subjects with the aim of assessing the effects of multiple treatments, and of observing the duration of the mood improvement.To do so, the investigators propose to study 72 subjects in a protocol of three treatments in three days. Subjects will be rated before and after each treatment, and will return for mood ratings at one week after treatment. Investigators hope that this characterization of LFMS will allow clinical research groups to perform large trials and to evaluate its clinical effectiveness in patient populations.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DEVICE	Low Field Magnetic Stimulation	Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-08-28
• Last updated: 2017-09-26
• Results posted: 2017-06-27

Locations

1 site across 1 country: United States