Clinical Studies are performed to characterize the response to LFMS treatment in target populations, explore its effects in related disorders, aid in the development of clinical treatment protocols, and support new system design with clinical validation studies. Smaller studies are performed at McLean Hospital by the LFMS group, and larger studies are being organized with clinical groups at four collaborating hospitals. We are currently:

  • Completing a study (n=72) on the duration of effects from three daily treatments in a bipolar population.
  • Recruiting for a pilot study of LFMS in PTSD in a veteran’s population.
  • Recruiting for an open label evaluation of long-term treatment protocols in a treatment resistant population.
  • Performing a pilot Study of LFMS in a depressed geriatric population.
  • Recruiting for a safety and efficacy study of LFMS in subjects with hypomania.

Functional Imaging is used to observe the physical response of the brain to LFMS. This is important for two reasons. First, LFMS produces an immediate change in brain activity in healthy subjects who do not have a psychiatric disorder; this allows studies to be performed quickly in a healthy population. Second, LFMS produces an immediate mood response in depressed subjects, so that when an imaging study is performed with depressed subjects we will be able to link the imaging result to the mood change as it happens. These two advantages will lead to an improved LFMS protocol and an increase in its clinical effect. Studies include:

  • Investigating functional imaging with fMRI and with EEG in control subjects in a first study.
  • The analysis of Near Infrared Spectroscopy (NIRS) data from 10 control subjects (20 sessions).

Modeling and Calculation at the Cellular Level is being pursued to determine how LFMS might be affecting neuronal structures and circuits as a means to increasing its effect as well as understanding the mechanisms of depression and anxiety in the brain. We are performing electromagnetic field calculations on the cellular level to determine the effects on membranes and synaptic structures, and will base small-scale cortical network simulations on these results. We are:

  • Calculating the effects of the pulsed fields in LFMS to the membrane voltages in the dendrites.
  • Preparing simulations of the effects of LFMS on cortical network activity.
  • Investigating the possibility of using opto-genetics and fMRI to manipulate neuronal structures in vivo.

New System Design is a part of the ongoing development in the LFMS program. The first priority is the design of a programmable and secure system that can be exported to collaborating clinical research sites. This system will have an emphasis on the security and encryption of study blinds as well as on performance tracking. The new system will also support the design and testing of smaller, more portable coils.

  • LFMS2 will offer robust operation and security in a clinical environment.
  • LFMS2 will provide programmability and a range of clinical protocols for evaluation.

LFMS2 will support smaller, more efficient coils as well as the evaluation of a personal, portable system.