Deep-brain stimulation, anon-invasive way of targeting neurons in the cortex, can significantly ease
symptoms of fatigue in multiple sclerosis patients, research drawn from a
clinical trial suggests.
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.
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 in
Germany conducted a pilot Phase 1/2a clinical trial to evaluate a technique
developed by Brainsway, called deep transcranial magnetic
stimulation 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.
Germany conducted a pilot Phase 1/2a clinical trial to evaluate a technique
developed by Brainsway, called deep transcranial magnetic
stimulation 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.
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.
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. 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.
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. 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.
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.
The combination H-coil plus dTMS was found to significantly
reduced fatigue symptoms — especially in the study arm given motor cortex
stimulation — with the treatment reducing FSS by a median of 1.0 point,
which was sustained during follow-up. Among patients whose treatment was to the
motor cortex, the median post-treatment drop in FSS was 1.74 compared to study
start.
reduced fatigue symptoms — especially in the study arm given motor cortex
stimulation — with the treatment reducing FSS by a median of 1.0 point,
which was sustained during follow-up. Among patients whose treatment was to the
motor cortex, the median post-treatment drop in FSS was 1.74 compared to study
start.
The treatment was found to be safe and well-tolerated in
all MS patients, including those who left the study early. “We
observed no serious side effects in patients treated with dTMS, and it is
therefore worth stressing the tolerability of this noninvasive
electrophysiological technique,” said Paul, the study’s principal
investigator, in a press release.
all MS patients, including those who left the study early. “We
observed no serious side effects in patients treated with dTMS, and it is
therefore worth stressing the tolerability of this noninvasive
electrophysiological technique,” said Paul, the study’s principal
investigator, in a press release.
The team is planning to further studies with a larger number of
participants to better evaluate H-coil dTMS as a treatment for MS patients —
for both fatigue and depression.
participants to better evaluate H-coil dTMS as a treatment for MS patients —
for both fatigue and depression.
“While the results are promising, they have to be
interpreted with caution, given the small sample size and the exploratory
nature of the study and of the efficacy analysis,” the researchers
conclude. Still, “in light of the safety and tolerability of rTMS
[repetitive TMS] treatment in MS-associated fatigue, our study strongly suggests
further investigating its potential therapeutic efficacy and the underlying
mechanisms.”
interpreted with caution, given the small sample size and the exploratory
nature of the study and of the efficacy analysis,” the researchers
conclude. Still, “in light of the safety and tolerability of rTMS
[repetitive TMS] treatment in MS-associated fatigue, our study strongly suggests
further investigating its potential therapeutic efficacy and the underlying
mechanisms.”
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