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โ† Trials
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At-home Treatment With Cortico-spinal tDCS for Amyotrophic Lateral Sclerosis

RecruitingNAAges 18 Years - anyAllUniversity of Trieste
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 24 months * Disease progression in the last 3 months * A score โ‰ฅ 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.
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What it tests

  • Real tDCS
  • Sham tDCS
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Where

1 site
Clinica Neurologica, Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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