Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Rehabilitative Trial With Transcranial Direct Current Stimulation (tDCS) in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of
neurological disorders that selectively affect motor neurons, the cells that control
voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the
body due to the degeneration of the upper and lower motor neurons. Current drugs approved for
ALS treatment only modestly slow disease progression.
Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been
demonstrated to modulate cerebral excitability in several neurodegenerative disorders and
modulate intracortical connectivity measures.
In this randomized, double-blind, sham-controlled study, the investigators will evaluate
whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal
tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate
intracortical connectivity, at short and long term.
Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of
neurological disorders that selectively affect motor neurons, the cells that control
voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the
body due to the degeneration of the upper and lower motor neurons. Current drugs approved for
ALS treatment only modestly slow disease progression.
Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been
demonstrated to modulate cerebral excitability in several neurodegenerative disorders and
modulate intracortical connectivity measures.
In this randomized, double-blind, sham-controlled study, the investigators will evaluate
whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal
tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate
intracortical connectivity, at short and long term.
Subjects will be randomized in two groups, one receiving a 10 day (5 days/week for 2 weeks)
treatment with anodal bilateral motor cortex tDCS and cathodal spinal tDCS and the other
receiving sham stimulation with identical parameters. After the intervention, patients will
be reassessed with a clinical and neurophysiological evaluation at 2 weeks, 2 months and 6
months after treatment. Furthermore, blood neurofilaments will be measured at each time
point.
Clinical evaluation will include the ALSFRS-R, ALSAQ-40, CBI, EQ-5D-5L, muscle strength
evaluated with the MRC scale.
Neurophysiological evaluation will include measures of intracortical connectivity, evaluated
with transcranial magnetic stimulation (TMS) as short interval intracortical inhibition
(SICI-ICF), long interval intracortical inhibition (LICI), short interval intracortical
facilitation (SICF).
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