Cortico-Spinal tDCS as Rehabilitative Intervention in Amyotrophic Lateral Sclerosis

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Updated on 16 February 2024
excitability
atrophy
transcranial direct current stimulation
weakness
neurological disorder
riluzole
motor neuron disease
amyotrophic lateral sclerosis
neurodegenerative disorders
primary lateral sclerosis

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 followed by an open-label phase, the investigators will evaluate whether a repetition of two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS, after a six months interval, may further outlast clinical improvement in patients with amyotrophic lateral sclerosis and can modulate intracortical connectivity, at short and long term.

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.

The present randomized, double-blind, sham-controlled study followed by an open-label phase will investigate a repetition of two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS, after a six months interval, may further outlast clinical improvement in patients with amyotrophic lateral sclerosis and modulate intracortical connectivity, at short and long term.

Details
Condition Myelopathy, Amyotrophic Lateral Sclerosis, Motor Neuron Disease
Age 18years - 100years
Treatment Anodal bilateral motor cortex and cathodal spinal tDCS, Sham bilateral motor cortex and sham spinal tDCS
Clinical Study IdentifierNCT04293484
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Last Modified on16 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with a diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria
Disease duration 24 months
Disease progression in the past 3 months
Score 2 at the item "swallowing" of the ALS Functional Rating Scale Revised
Score 2 at the item "walking" of the ALS Functional Rating Scale Revised
Treatment with steady regimen of riluzole for a minimum of 1 month before study entry, and desiring its continuation
Able to give informed consent
Written informed consent

Exclusion Criteria

Motor neuron diseases other than ALS
Severe head trauma in the past
History of seizures
History of ischemic stroke or hemorrhage
Pacemaker
Metal implants in the head/neck region
Severe comorbidity
Intake of illegal drugs
Pregnancy
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