Cortico-Spinal tDCS as Rehabilitative Intervention in Amyotrophic Lateral: a Randomized, Double-blind, Sham-controlled Trial Followed by an Open-label Phase

Study Purpose:

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.

Study Status:

Not recruiting

Disease:

Motor Neuron Disease, Familial , Amyotrophic Lateral Sclerosis With Dementia

Study Type:

Interventional

Type of Intervention:

Device

Intervention Name:

Anodal bilateral motor cortex and cathodal spinal tDCS, Sham bilateral motor cortex and sham spinal tDCS

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Barbara Borroni, MD, Università degli Studi di Brescia, Alberto Benussi, MD, Università degli Studi di Brescia

Clinicaltrials.gov ID:

NCT04293484

Neals Affiliated?

No

Coordinating Center Contact Information

Full Study Summary: