A 26-patient clinical trial completed double-blinded at has provided Brainsway Ltd. the results assessing the safety and effectiveness of its Deep TMS device used in treating patients with MS (multiple sclerosis).
The trial participants were separated into three groups: a treatment group receiving 18 Hz, (high-frequency) left pre-frontal stimulation, a control group with false-stimulation, and a treatment group receiving low frequency stimulation of 5 Hz to the motor cortex. Each participant received treatment three times a week for six weeks; the effects of their treatments were evaluated over this time period.
The effects the treatments had on participant’s fatigue levels were studied using standard rating scales for fatigue, including the FSS (Fatigue Severity Scale), MFIS (Modified Fatigue Impact Scale and the VAS (Visual Analogue Scale). Depressions level effects were studied with the Hamilton Rating Scale, BDI (Beck Depression Inventory) and PANAS (Positive and Negative Affect Scale).
Studies of the fatigue rating scales showed great improvement in Fatigue Severity scores in the group receiving motor cortex stimulation and slight improvement found in the group receiving left pre-frontal stimulation. Both groups showed non-important improvement on the fatigue rating scales.
Depression showed a great improvement on the Beck Depression Inventory and Positive and Negative Affect Scale in the motor cortex group while other groups’ scores did not greatly change. The main investigator stated that these results show that Brainways’ device providing Deep TMS therapy works well in treating MS patients and is safe to use.