NCT07006571 At-home Treatment With Cortico-spinal tDCS for Amyotrophic Lateral Sclerosis
| NCT ID | NCT07006571 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Trieste |
| Condition | ALS |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2029-04-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-05-19 with a primary completion date of 2029-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Alberto Benussi, MD
PRINCIPAL INVESTIGATOR
University of Trieste
Frequently Asked Questions
Who can join the NCT07006571 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ALS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07006571 currently recruiting?
Yes, NCT07006571 is actively recruiting participants. Contact the research team at benussialberto@gmail.com for enrollment information.
Where is the NCT07006571 trial being conducted?
This trial is being conducted at Trieste, Italy.
Who is sponsoring the NCT07006571 clinical trial?
NCT07006571 is sponsored by University of Trieste. The principal investigator is Alberto Benussi, MD at University of Trieste. The trial plans to enroll 40 participants.
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