Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07006571

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

Led by University of Trieste · Updated on 2025-06-13

40

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients with a probable or laboratory-supported diagnosis of ALS, or defined ALS according to current clinical criteria
  • Age greater than 18 years
  • Onset of disease 24 months or less
  • Disease progression in the last 3 months
  • Score of 2 or more on the "respiratory failure" item of the ALS Functional Rating Scale Revised (ALSFRS-R)
  • Stable treatment with riluzole or edaravone for at least 1 month prior to enrollment, or no ALS-specific treatment
  • Presence of a caregiver who can assist and has completed training to use the device
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Presence of fixed electrical stimulators like pacemakers, nerve stimulators, or hearing implants
  • Presence of intracranial metal foreign bodies such as splinters, prostheses, screws, or nails
  • History of epilepsy
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinica Neurologica, Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, Trieste, Italy, 34149

Actively Recruiting

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Research Team

A

Alberto Benussi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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