At-home cortico-spinal tDCS for ALS.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: benussialberto@gmail.com
• Phone: +39 0403994282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.