Following the initial, serendipitous observation of a rapid-acting mood-elevating effect at McLean Hospital, five randomized, controlled clinical studies have investigated the effect of LFMS in Bipolar Depression (BPD) and Major Depressive Disorder (MDD).

Although we do not know the exact mechanism of action, we do know that LFMS has a physiological effect on brain activity. An independent PET-FDG study with healthy subjects at the NIH demonstrated that LFMS reduces glucose utilization in the brain. Furthermore, an fMRI imaging study at Weill Cornell indicates that LFMS reduces functional connectivity in brain networks associated with depression.

The Tal Medical LFMS Device is limited by US Federal Law to Investigational Use.


Clinical Studies

 

PILOT STUDY #1 IN BIPOLAR DEPRESSION (MCLEAN HOSPITAL, 2004)

This randomized, sham controlled, single-blind study tested a single 20 minute LFMS treatment in bipolar subjects (N=54), with the goal of confirming the serendipitous observation of LFMS having a rapid anti-depressant effect. The study showed statistically significant improvement in depression symptoms as measured on the primary end-point of Brief Affect Scale.

Publication can be found here: 

Low-Field Magnetic Stimulation In Bipolar Depression Using An MRI-Based Stimulator
Rohan, M et al; American Journal of Psychiatry, 2004.

 

PET-FDG IMAGING STUDY (NIMH, 2010)

This randomized, sham controlled, blinded study tested how a single, 40 minute LFMS treatment affects brain metabolism in 15 healthy subjects using PET imaging. The goal of the study was to validate that LFMS has a physiological effect on the brain. The study showed a statistically significant, negative correlation between the strength of the induced electric field produced by LFMS and regional brain activity (measured by glucose uptake). 

Publication can be found here: 

Effects Of Low-Field Magnetic Stimulation On Brain Glucose Metabolism
Volkow, N et al; Neuroimage, 2010.

 

PILOT STUDY #2 IN BIPOLAR AND UNIPOLAR DEPRESSION (MCLEAN HOSPITAL, 2014)

This randomized, sham-controlled, double-blind study investigated a single 20 minute LFMS treatment in treatment resistant bipolar (BPD) and unipolar (MDD) depressive patients (N=42 and 21, respectively). The main objectives of the study were to replicate the previously observed rapid effect in BPD, as well as explore LFMS efficacy in MDD. The study showed that LFMS provided a statistically significant improvement compared to sham treatment, as measured with the Hamilton Depression scale (HAMD17, 3.1 points) for the combined BPD and MDD sample.

Publication can be found here: 

Rapid Mood-Elevating Effects Of Low Field Magnetic Stimulation In Depression
Rohan, M et al; Biological Psychiatry, 2014.

 

TRIAL IN Treatment Resistant Major Depressive Disorder (RAPID, 2016)

This randomized, sham-controlled, double-blind, multi-center study investigated the efficacy of 20 minute LFMS treatments over two consecutive days in a treatment resistant unipolar depressive (MDD) population (N=85). The National Institute of Mental Health fully funded the trial under its RAPID program. Led by Massachusetts General Hospital, 6 major US research centers participated in the study. The study showed no difference between active and sham treatment in MDD for the 20 minute dose.

Analysis is complete and is being prepared for publication. For more information, please click here

 

DOSE OPTIMIZATION STUDY (SOLIDD, 2016)

This randomized, sham-controlled, double-blind, multi-center study investigated the efficacy of various LFMS dosing protocols in treatment resistant unipolar depressive (MDD) population (N=122). A 60 minute dosing regimen over four consecutive days demonstrated a rapid, clinically meaningful effect that was consistent across multiple instruments (HAMD17, MADRS, VAS, PANAS), but it did not achieve statistical significance on its primary end-point of the Hamilton Depression scale (HAMD6). On the Montgomery-Asberg Depression Scale (MADRS), the 60 minute arm showed improvement of 2.7 points over sham (p=0.09). Consistently with the RAPID trial, a 20 minute dose showed no effect. 

Analysis is complete and is being prepared for publication. For more information, please click here

 

fMRI Imaging study in MDD (Weill Cornell Medical College, 2016)

This randomized, sham-controlled, double-blind study investigated the efficacy of  20 minute LFMS treatments, applied over three days, in treatment resistant unipolar depression (MDD, N=66, 33 per protocol).  The study also tested the effect of LFMS on functional brain connectivity using fMRI. The study demonstrated statistically significant reduction in functional connectivity in brain networks associated with depression. The study also showed improvement in clinical symptoms as measured by Hamilton Depression scale (HAMD6) and Visual Analog Scale (VAS) (p=0.02 and 0.002, respectively) in the per protocol sample. No meaningful change was observed on PANAS. 

This study is being prepared for publication. For more information, please click here

 

Feasibility study of simultaneous LFMS and EEG recording (2017)

This sham-controlled study describes a new method for removing the electrical artifact associated with simultaneous LFMS and EEG recording. This technology will pave the way for closed-loop neuromodulation based on short-latency analysis of ongoing neural activity.

Publication can be found here: 

On The Handling Of Stimulation Artifacts During Simultaneous Electroencephalography (EEG) And Transcranial Low Field Strength Magnetic Stimulation (LFMS) 
Miskovic V et al, Brain Stimulation, 2017 


Preclinical Studies

 

PRECLINICAL STUDY OF LFMS ACTIVITY (MCLEAN HOSPITAL, 2005)

This randomized, sham controlled study compared a single 20 min LFMS treatment in rodents to fluoxetine and desipramine. LFMS was comparable to the effects of fluoxetine and desipramine in the forced swim test, but not on general locomotor activity or fear-potentiated startle.

Publication can be found here: 

Antidepressant-Like Effects Of Cranial Stimulation Within A Low-Energy Magnetic Field In Rats
Carlezon, W et al; Biological Psychiatry, 2005.