Home-based electrical brain stimulation tested in people with ALS
Tests a home device giving mild brain and spinal electrical stimulation in adults with ALS.
Plain-language title generated from the registry record
Registry title: At-home Treatment With Cortico-spinal tDCS for Amyotrophic Lateral Sclerosis
Key facts
- Where
- Trieste, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ALS (amyotrophic lateral sclerosis) who have a caregiver and can use a stimulation device at home for 16 weeks.
- Age
- Older than 18 years.
- Sex
- All sexes can join.
- Disease stage
- Probable (lab-supported) or defined ALS. Disease began 24 months ago or less. The disease has progressed in the last 3 months. A score of 2 or more on the respiratory failure item of the ALSFRS-R scale.
- Earlier treatment
- Riluzole or edaravone is allowed if the dose has been stable for at least 1 month. No ALS-specific treatment is also allowed.
Main reasons for not taking part
- Fixed electrical stimulators such as a cardiac pacemaker, nerve stimulator or hearing implant
- Certain metal objects inside the skull, such as splinters, some prostheses, screws or nails
- History of epilepsy
- Pregnancy
Read by machine on 12 November 2026.
Where in Italy
- Clinica Neurologica, Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyContact: Alberto Benussi, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Trieste
- Trial code
- NCT07006571
- Record updated
- 13 June 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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 a history of epilepsy; People with particular intracranial metal foreign bodies (e.g. splinters, some prostheses, screws and nails) that could interact with the electric field; As the effects of tDCS on the developing fetus are not known, pregnant women will be excluded from the study.