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

NCT07006571 | Recruiting

• 1 other identifier: 371/2024H
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

ALS; ALS (Amyotrophic Lateral Sclerosis)

Keywords

At-home tDCS; ALS; tDCS-ALS

Outcome Measures

Primary Outcomes (1)

• Difference in the ALSFRS-R between groups at 16 weeks.

  Difference in ALS Functional Rating Scale-Revised (ALSFRS-R) between groups at 16 weeks. The ALSFRS provides a physician-generated estimate of the patient's degree of functional impairment, which can be evaluated serially to objectively assess any response to treatment or progression of disease. The ALSFRS includes ten questions that rate the patients level of functional impairment in performing one of ten common tasks. Each task is rated on a five-point scale from 0 (can't do) to 4 (normal ability). Individual item scores are summed to produce a reported score of between 40 (no impairment) and 0 (severe impairment).

  Baseline - 16 weeks

Secondary Outcomes (7)

• Difference in the ALSFRS-R between groups at 32 weeks and 48 weeks

  32 weeks - 48 weeks

• Difference in the ALSAQ-40 between groups

  Baseline - 16 weeks - 32 weeks - 48 weeks

• Difference in the Caregiver Burden Inventory (CBI) score between groups

  Baseline - 16 weeks - 32 weeks - 48 weeks

• Difference in Quality of Life EQ-5D-5L Scale between groups

  Baseline - 16 weeks - 32 weeks - 48 weeks

• Difference in Muscle strength assessed by manual dynamometer from baseline

  Baseline - 16 weeks - 32 weeks - 48 weeks

Study Arms (2)

Real tDCS

EXPERIMENTAL

The device used for transcranial direct current stimulation (tDCS) is the Soterix Medical 1x1 tES mini-CT. The device is designed to be used at home by patients, with built-in safety controls to ensure adequate and safe stimulation. The electrodes of the device will be positioned according to the following scheme: one electrode (anode) will be applied on the skin overlying the motor cortices, one electrode (cathode) will be applied on the skin overlying the cervical cord, in the area corresponding to C6. Dosage: 4 mA for the anodal electrode and 4 mA for the cathodal electrode (intensity could be reduced if not tollerate by the patient). Duration of stimulation: 20 minutes per session. Frequency: 5 days per week (Monday - Friday) for 16 weeks.

Device: Real tDCS

Sham tDCS

SHAM COMPARATOR

The placebo device uses the same model as the tDCS device but without actually delivering the current. The electrodes will be positioned in the same way as the active device, but the current flow will be limited to the ramp-up (start of stimulation) and ramp-down (end of stimulation) phase, mimicking the sensation of stimulation without providing actual treatment. Dosage: Simulation of stimulation without actual current. Duration of stimulation: 20 minutes per session. Frequency: 5 days per week (Monday - Friday) for 16 weeks.

Device: Sham tDCS

Interventions

Real tDCS DEVICE

The electrodes of the device will be positioned according to the following scheme: one electrode (anode) will be applied on the skin overlying the motor cortices, one electrode (cathode) will be applied on the skin overlying the cervical cord, in the area corresponding to C6. Dosage: 4 mA for the anodal electrode and 4 mA for the cathodal electrode (intensity could be reduced if not tollerate by the patient). Duration of stimulation: 20 minutes per session. Frequency: 5 days per week (Monday - Friday) for 16 weeks.

Real tDCS

Sham tDCS DEVICE

The electrodes will be positioned in the same way as the active device, but the current flow will be limited to the ramp-up (start of stimulation) and ramp-down (end of stimulation) phase, mimicking the sensation of stimulation without providing actual treatment. Dosage: Simulation of stimulation without actual current. Duration of stimulation: 20 minutes per session. Frequency: 5 days per week (Monday - Friday) for 16 weeks.

Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

Clinica Neurologica, Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, Trieste, 34149, Italy

RECRUITING

Related Publications (2)

• Benussi A, Di Lorenzo F, Dell'Era V, Cosseddu M, Alberici A, Caratozzolo S, Cotelli MS, Micheli A, Rozzini L, Depari A, Flammini A, Ponzo V, Martorana A, Caltagirone C, Padovani A, Koch G, Borroni B. Transcranial magnetic stimulation distinguishes Alzheimer disease from frontotemporal dementia. Neurology. 2017 Aug 15;89(7):665-672. doi: 10.1212/WNL.0000000000004232. Epub 2017 Jul 26.

  PMID: 28747446 BACKGROUND

• Benussi A, Koch G, Cotelli M, Padovani A, Borroni B. Cerebellar transcranial direct current stimulation in patients with ataxia: A double-blind, randomized, sham-controlled study. Mov Disord. 2015 Oct;30(12):1701-5. doi: 10.1002/mds.26356. Epub 2015 Aug 14.

  PMID: 26274840 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alberto Benussi, MD

  University of Trieste

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Benussi, MD

CONTACT

+39 0403994282; benussialberto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)