RECRUITINGINTERVENTIONAL

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

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

About This Trial

Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that causes gradual muscle weakness and loss of muscle mass. It affects all muscles that control movement, speech, swallowing, and breathing. Unfortunately, ALS is currently incurable, and treatments are limited. Only two medications, riluzole and edaravone, have been approved and can slightly extend survival, typically between 20 and 48 months from diagnosis. Recent research has identified a useful biomarker known as neurofilament light chain (NfL), which increases in the blood as nerve cells become damaged. Measuring NfL levels can help track the progression of ALS. A promising non-invasive treatment called transcranial direct current stimulation (tDCS) has shown potential benefits for patients with ALS. tDCS involves safely applying mild electrical currents to specific areas of the brain and spinal cord. This approach aims to stimulate nerve cells, potentially improving their function and slowing disease progression. Initial studies have reported temporary improvements in muscle strength and survival when tDCS was used over a short period. Based on these encouraging results, our study proposes a new home-based tDCS treatment program specifically designed for ALS patients. Participants will use an easy-to-operate, safe, and portable device at home. The treatment involves placing electrodes on the scalp and the neck area to stimulate both the motor areas of the brain and the spinal cord. Therapy sessions will occur five days per week over 16 weeks. This home-based approach allows patients to comfortably receive therapy without daily trips to the hospital, making treatment more accessible and convenient. By providing this therapy at home, the investigators aim to improve the quality of life for ALS patients and explore new possibilities in treating and managing ALS and other neurodegenerative diseases.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female patients with a probable, laboratory-supported diagnosis of ALS, or defined ALS according to current clinical criteria - Age greater than 18 years - Onset of disease ≤ 24 months - Disease progression in the last 3 months - A score ≥ 2 on the "respiratory failure" item on the ALS Functional Rating Scale Revised (ALSFRS-R) - Treatment with riluzole or edaravone is permitted, provided it has been stable for at least 1 month prior to enrollment in the study, or no ALS-specific treatment - Presence of a caregiver who can assist the patient and who has successfully completed the necessary training in the use of the device - Signature of willing to sign a consent form Who Should NOT Join This Trial: - People with fixed electrical stimulators (e.g. cardiac pacemakers, nerve stimulators, hearing implants) that would not work or would be damaged by the electric field; - People with particular intracranial metal foreign bodies (e.g. splinters, some prostheses, screws and nails) that could interact with the electric field - People with a history of epilepsy; - As the effects of tDCS on the developing fetus are not known, pregnant women will be excluded from the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Male or female patients with a probable, laboratory-supported diagnosis of ALS, or defined ALS according to current clinical criteria * Age greater than 18 years * Onset of disease ≤ 24 months * Disease progression in the last 3 months * A score ≥ 2 on the "respiratory failure" item on the ALS Functional Rating Scale Revised (ALSFRS-R) * Treatment with riluzole or edaravone is permitted, provided it has been stable for at least 1 month prior to enrollment in the study, or no ALS-specific treatment * Presence of a caregiver who can assist the patient and who has successfully completed the necessary training in the use of the device * Signature of informed consent Exclusion Criteria: * People with fixed electrical stimulators (e.g. cardiac pacemakers, nerve stimulators, hearing implants) that would not work or would be damaged by the electric field; * People with particular intracranial metal foreign bodies (e.g. splinters, some prostheses, screws and nails) that could interact with the electric field * People with a history of epilepsy; * As the effects of tDCS on the developing fetus are not known, pregnant women will be excluded from the study.

Treatments Being Tested

DEVICE

Real tDCS

The electrodes of the device will be positioned according to the following scheme: one electrode (anode) will be applied on the skin overlying the motor cortices, one electrode (cathode) will be applied on the skin overlying the cervical cord, in the area corresponding to C6. Dosage: 4 mA for the anodal electrode and 4 mA for the cathodal electrode (intensity could be reduced if not tollerate by the patient). Duration of stimulation: 20 minutes per session. Frequency: 5 days per week (Monday - Friday) for 16 weeks.

DEVICE

Sham tDCS

The electrodes will be positioned in the same way as the active device, but the current flow will be limited to the ramp-up (start of stimulation) and ramp-down (end of stimulation) phase, mimicking the sensation of stimulation without providing actual treatment. Dosage: Simulation of stimulation without actual current. Duration of stimulation: 20 minutes per session. Frequency: 5 days per week (Monday - Friday) for 16 weeks.

Locations (1)

Clinica Neurologica, Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, Trieste, Italy