At-home Treatment With Cortico-spinal tDCS for Amyotrophic Lateral Sclerosis
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 an
| Condition(s) | ALS, ALS (Amyotrophic Lateral Sclerosis) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 invol |
| Who can participate | 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, |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Trieste |
| Locations | Trieste, Trieste, Italy |
| Start date | 2025-05-19 |
| NCT ID | NCT07006571 |
| Official listing | https://clinicaltrials.gov/study/NCT07006571 |