This page describes the clinical studies that are currently underway at the LFMS program. Studies are at various stages, and details about each study can be found below.
LFMS for Depression and Anxiety in PTSD: a Pilot Study
This is a pilot study of the effects of LFMS on PTSD, to be performed in a population of veterans. LFMS was observed to reduce symptoms of both anxiety and depression in our recent study performed in a mixed population of subjects with major depression or bipolar depression (Rohan et al, Biological Psychiatry Aug 1 2014). This suggests that it might be a potential treatment for disorders that have significant amounts of these symptoms, such as PTSD. A successful outcome could be that LFMS is well tolerated by all participants. Because this is a pilot study, we do not expect to detect a statistically significant result but do expect to obtain an estimate of the treatment effect size. This will be used in planning for a study to be performed with the Veterans’ Administration next year.
PTSD has core symptoms of re-experiencing, avoidance, and hyper-arousal, as well as related symptoms of depression and anxiety. Our goal is to provide sufficient relief from the related symptoms of depression and anxiety so that the core traumatic symptoms can be addressed more easily. A possible additional outcome could be a reduction in the core symptoms of PTSD. This response would be consistent with the “calming” and “centering” effects of LFMS that have been reported by depressed subjects.
Why do we think that LFMS will have a beneficial effect on PTSD? Because the itemized responses to LFMS treatment in other depressed subjects correspond to symptoms commonly seen in PTSD. The plot below shows the details of the response to LFMS after a single treatment in our 2014 study. The mean response to each of the individual items of the PANAS scale are shown, separated into “active” and “sham” groups. A blue (active) line that is larger than a red line may indicate an item with active response to LFMS. The Positive and Negative Affect Schedule (PANAS) is a two part, self-report, mood rating scale with 10 questions rating positive symptoms and 10 questions rating negative symptoms.
LFMS for depression and anxiety in PTSD: a Pilot Study
The symptom details of the response to LFMS are shown in the figure below.
Figure Symptom response profile shows that both depression and anxiety are affected by LFMS
Status: Currently recruiting.
Low Field Magnetic Stimulation in Bipolar Depression: Three Daily Treatments
In this study we are characterizing the duration of the anti-depressant effect of LFMS. In our previous studies we demonstrated that LFMS causes an immediate reduction in depression, after one treatment, in those who respond. We also demonstrated that the new LFMS device replicates the reduction in depression that was seen in the original MRI discovery. In this current study we administer three daily treatments with a one-week follow up visit to determine how much of the change in mood remains at one week. The study is being performed in participants with Bipolar Depression. This study was a sham controlled, double-blinded parallel design experiment. The study began in July 2013, and we completed 50 subjects.
Figure Histogram of change in MADRS at one week for 48 subjects, blinded. Half had active LFMS and half had sham LFMS. No conclusions can be drawn from this blinded data while the study is in progress, but the distribution suggests that some effects from participation in the study will be found.
Status: Recruitment completed.
Pilot Study of LFMS in a Depressed Geriatric Population
This is an initial evaluation of LFMS as a treatment for depression in a geriatric population. It will be performed in collaboration with the Geriatric Outpatient Clinic at McLean Hospital.
This pilot study is a first step in extending the development of LFMS to applications in a similar but new population, those suffering from geriatric bipolar depression (GBD). This protocol will follow our standard evaluation schedule of three treatments on consecutive days, with one follow-up visit; this is a crossover study in which the treatments and follow-up are repeated after a one-week washout using the alternate procedure (active, sham).
The mechanism of depression in a geriatric population (>55) may differ from those in a younger population. In particular, brain structures and connectivity have changed, and there is the increased risk of additional diagnoses such as dementia that might confound treatment and assessment. In this study we will extend the findings of LFMS in the general population to directly address the treatment of bipolar depression in a geriatric population. The LFMS group at McLean is currently pursuing a multi-treatment, parallel design study in subjects (21-65) with bipolar disorder using a similar treatment protocol, and the results from this study will be comparable to the results from that study because of this similarity.
Status: Currently recruiting.
Pilot Study of LFMS for Hypomania
This study will test the safety of LFMS in subjects with bipolar disorder who are in hypomania. In our studies of LFMS so far there have been no reports of the kindling of mania, and this study will be a confirmation of this. We will also assess the possibility that LFMS may act as a mood stabilizer in this population.
Given the history of antidepressant medications to kindle mania in individuals, it is important to determine if LFMS has the potential to kindle mania as well. LFMS has been studied solely in bipolar depression, unipolar depression, and healthy controls. It is important to note that, to date, there have been no observations of kindling of hypomania or symptoms of mania.
Adverse side effects such as kindling have prevented many antidepressant medications from being useful in treating bipolar depression. If kindling of manic symptoms is not demonstrated, LFMS has the potential to become a useful treatment for bipolar depression. Additionally, LFMS may have the potential to decrease hypomanic symptoms, which would make it a viable treatment option as a mood stabilizer.
The lack of demonstrated side effects from LFMS to date will allow widespread use, either as a monotherapy or as an adjunct therapy, without significant side effects.
Status: Recruiting from inpatient.
Extended Open Label in Treatment Resistant Cases
This is an open label study with limited enrollment that uses an extended protocol in treatment resistant patients with depression and anxiety based disorders. An initial week with five daily visits is followed by long-term maintenance. Enrollment is made by clinician referral. This study provides the first assessment of both crisis intervention in severely depressed subjects as well as maintenance lasting up to six months.
This study will assess the effects of daily LFMS treatments in participants suffering from affective disorders. We hypothesize that subjects will show both immediate mood improvement during an initial week as well as sustained mood improvement over subsequent months of maintenance.
LFMS can only be used as a successful treatment if its effects are strengthened by multiple applications and endure past the treatment time. The LFMS group will allow inclusion of participants with depression and/or anxiety related disorders into this open label study with physician approval. The three leading anxiety based disorders in addition to mood disorders that will be considered include Post Traumatic Stress Disorder (PTSD), Obsessive Compulsive Disorder (OCD), and general anxiety disorder (GAD). The symptoms of anxiety in these three disorders are often accompanied by symptoms of depression, and while LFMS might not address the fear-related arousal of PTSD, the compulsions of OCD, or the dementia associated with geriatric agitation it may provide relief from the symptoms of anxiety.
Status: Enrollment by referral.