Deep-brain stimulation, a non-invasive way of targeting neurons in the cortex, can significantly ease symptoms of fatigue in multiple sclerosis (MS) patients, research drawn from a clinical trial suggests.
These results, published in the journal Neurology: Neuroimmunology and Neuroinflammation, are in an article titled “Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue.”
Up to 90 percent of MS patients are believed to experience severe fatigue, a type of mental and physical exhaustion that can have a serious impact on a person’s work and social life. Because treatment options are limited for these patients, researchers are looking at deep-brain stimulation as a way to potentially alleviate this limiting condition.
Researchers at the NeuroCure Clinical Research Center (NCRC) in Germany conducted a pilot Phase 1/2a clinical trial (NCT01106365) to evaluate a technique developed by Brainsway, called deep transcranial magnetic stimulation (dTMS) and using a specifically developed H-coil that is capable of stimulating brain regions up to three times deeper than “figure-of-eight coils” used in standard TMS, the study states.
Areas in the brain’s cortex are thought to play a key role in MS-related fatigue.
dTMS is a type of non-invasive stimulation that activates deep-brain structures through the use of electromagnetic fields that either excite or inhibit neurons. The approach is being increasingly used to diagnose and treat a range of neurological and psychiatric disorders.
To evaluate the safety and potential of repetitive H-coil dTMS as a treatment, researchers led by Friedemann Paul began by assessing the severity of MS-associated symptoms using a standardized survey and the fatigue severity scale (FSS). Twenty-seven of the 28 treated patients had FSS scores of 4.0 or more at the study’s start; FSS ranks fatigue on a scale from 1 to 7.
The clinical study enrolled 33 participants, but five left early because of mild side effects that included headaches or facial/scalp discomfort. The remaining 28 received either the dTMS treatment — one group to the prefrontal cortex, another to the motor cortex — or a sham procedure three times a week for six weeks. The treatment involved a stimulation H-coil being placed above the patient’s head, which generated a magnetic field to influence nerve activity and neural circuits in the brain.