At-home cortico-spinal tDCS for ALS.

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

This treatment tests whether daily at-home cortico-spinal tDCS can slow nerve damage and symptoms in adults with early ALS.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Trieste (Academic / other)
• Locations: 1 site (Trieste, Trieste)
• Trial ID: NCT07006571 on ClinicalTrials.gov

What this trial studies

The protocol compares real versus sham cortico-spinal transcranial direct current stimulation (tDCS) delivered at home with caregiver assistance after clinic training. Participants use a portable tDCS device targeting motor cortex and spinal pathways according to a set treatment schedule. Blood neurofilament light chain (NfL) levels and standardized clinical function scores are tracked over time to monitor neuronal damage and clinical change. Enrollment focuses on adults with recent-onset progressive ALS who can attend initial visits at the Trieste center and have a trained caregiver.

Who should consider this trial

Good fit: Adults over 18 with a probable or defined ALS diagnosis within 24 months of onset, recent clinical progression, a caregiver able to be trained, and stable or no ALS-specific medication are the intended participants.

Not a fit: People with implanted electrical stimulators or certain intracranial metal, those with disease beyond the enrollment window, or those without a capable caregiver may not be eligible or likely to benefit.

Why it matters

Potential benefit: If effective, home cortico-spinal tDCS could slow progression of neuronal damage and help preserve muscle function while providing a low-cost, accessible therapy option for people with ALS.

How similar studies have performed: Early small studies reported transient improvements in muscle strength and hints of survival benefit after short courses of cortico-spinal tDCS, but the evidence is limited and preliminary.

Eligibility criteria

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.

Where this trial is running

Trieste, Trieste

• Clinica Neurologica, Azienda Sanitaria Universitaria Giuliano Isontina — Trieste, Trieste, Italy (Recruiting)

Study contacts

• Principal investigator: Alberto Benussi, MD — University of Trieste
• Study coordinator: Alberto Benussi, MD

Conditions ALS; At-home tDCS; tDCS-ALS