Rehabilitative Trial With tDCS in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Anodal bilateral motor cortex and cathodal spinal tDCS; Sham bilateral motor cortex and sham spinal tDCS
Intervention type(s): Device; Device
Intervention description(s): 10 sessions of anodal bilateral motor cortex and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks); 10 sessions of sham bilateral motor cortex and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Transcranial Direct Current Stimulation