Evaluation of Home-based Transcranial Direct Current Stimulation on Physical Function in Patients With Amyotrophic Lateral Sclerosis: a Randomized Controlled Trial

What this Trial Is About

Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that causes muscle weakness and loss of muscle mass, affecting muscles controlling movement, speech, swallowing, and breathing. It is incurable with limited treatments, and only two drugs, riluzole and edaravone, have been approved to slightly extend survival. This research explores a promising biomarker, neurofilament light chain (NfL), which rises in the blood as nerve damage occurs and helps track ALS progression. The study evaluates a home-based treatment using transcranial direct current stimulation (tDCS), a non-invasive technique applying mild electrical currents to the brain and spinal cord. Participants will use a safe, portable device at home with electrodes placed on the scalp and neck to stimulate motor areas. Treatment sessions last 20 minutes, five days per week, over 16 weeks. The study compares real tDCS with a placebo device that mimics stimulation without delivering current. Participants will undergo assessments including muscle strength, quality of life, caregiver burden, and plasma neurofilament levels at baseline and multiple follow-ups up to 48 weeks. The main outcome measures the difference in physical function between groups at 16 weeks. Safety monitoring, adherence checks, and long-term evaluation of survival and symptom progression are included. The approach aims to improve therapy accessibility and quality of life for ALS patients by enabling treatment at home.

At-home Treatment With Cortico-spinal tDCS for Amyotrophic Lateral Sclerosis