$705 Raised
"According to the Veterans’ Administration up to 20% of the 3 million veterans who served in Iraq and Afghanistan, and 30% of the veterans from the Vietnam War suffer from PTSD."

Michael Rohan, PhD

Principal Investigator
McLean Hospital

I became involved in LFMS because I was one of the three people who made its discovery in 2001, and I have carried on the development of this treatment since then. My professional and career background is interdisciplinary and a match for the work needed to develop this new device and treatment: I have a background in electromagnetic fields and their effects on nerves from earlier in my career, a background in electromagnetic system design, and have been working in psychiatric research for 15 years. The LFMS research group at McLean includes psychologists and scientists in other fields such as statistics and clinical trials design, as well as electrical engineers - this is truly a multidisciplinary effort.

Summary

Posttraumatic stress disorder is a crippling disease that affects at least 8 million Americans in a given year. It has a high incidence in veterans and in their families, heavily impacting their lives and daily functioning. PTSD can also be one of the most challenging diseases to treat. LFMS is a new electromagnetic treatment for depression that produces a rapid reduction in both depression and anxiety. In our recent study subjects reported a reduction in these symptoms immediately at the end of the treatment session. In this study we will observe the effects of LFMS in veterans with PTSD as a first test of its use as a treatment.

This will be a study of subjects with PTSD who have had military service. The study will randomly treat half the volunteers with active LFMS and the other half with sham.  Subjects may choose to receive an additional three days of active treatment to guarantee active treatment. The study will consist of a screening visit, three treatments on consecutive days, and a one-week follow-up visit. The subjects will perform mood assessments with a psychologist before and after each treatment to allow measurement of the effect.

PTSD has a core list of symptoms that includes avoidance, hyper-arousal and hyper-vigilance. These symptoms are often combined with depression and anxiety. Independently, each of these symptom areas is challenging to treat but when combined in PTSD they become a formidable obstacle to the well-being and functioning of service members and their families.

LFMS is a unique treatment that is in its early development as a treatment for depression. It uses very low fields at a high frequency, and our current hypothesis is that it affects the calculations in the synapses in the brain, in the same location where pharmaceutical antidepressant medications have their effect. In our recent study subjects who had Bipolar Depression or Major Depression felt an improvement in mood immediately after treatment, as well as a reduction in anxiety. Our goal is that reductions in depression and anxiety will allow subjects with PTSD to focus on their core list of symptoms; LFMS may be able to directly affect these symptoms as well.

Why is this important?

PTSD affects people who have had traumatic experiences, including victims of accidents, disasters, and war: it can particularly affect veterans and military service members. According to the Veterans’ Administration up to 20% of the 3 million veterans who served in Iraq and Afghanistan, and 30% of the veterans from the Vietnam War suffer from PTSD.

There is not a standardized, generally successful treatment for PTSD. Individual cases of PTSD differ, and there is no way to address all of the symptoms. Existing treatments for PTSD are a combination of cognitive and behavioral therapy with antidepressant and anti-anxiety medication. These challenges make the treatment of PTSD difficult.

LFMS offers a reduction in symptoms of depression and of anxiety. Volunteers in studies who respond to treatment report an increased sense of “focus” and of “clarity.” In this proposed study we expect the same immediate reduction in symptoms of depression and anxiety that is observed in our studies of depressed subjects. Our hypothesis is that a reduction in these two areas of symptoms will make the treatment of the core symptoms of PTSD – avoidance, vigilance, hyper-arousal – easier to treat. Our hope is that the stabilizing effects of LFMS will also help to reduce these core symptoms and to provide a real addition to the treatment of PTSD.

Who will benefit?

This study will benefit people with PTSD. The immediate target will be veterans, both because of the strong need for treatments in this population and because they are a well-defined group of volunteers who therefore will provide a consistent set of data. However, results from this test of LFMS in PTSD will be applicable to all victims of PTSD from any cause. In the short term this study will provide an initial test of effectiveness in PTSD; in the longer term the data will be used as the basis for a proposal to the Veterans Administration. This study will have a more prolonged evaluation of clinical effects, and will also perform functional MRI with a subset of the volunteers in order to observe how LFMS works through treatment. If LFMS can provide a new treatment that helps with symptoms in PTSD then it can be applied to all who suffer from it, from whatever cause.

Budget

This project does not have other funding. It is a pilot project whose data will be used to apply for a large scale research project with the Veterans Administration. All funds (except subject costs) will be used for staff salaries. The LFMS Device, laboratory computers and analysis software are in place.