At-home Treatment With Cortico-spinal tDCS for Amyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Trieste
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Real tDCS
DeviceThe 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.
Sham tDCS
DeviceThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Real tDCSExperimental treatment 1 intervention
Group B: Sham tDCSSham comparator 1 intervention
Trial outcomes
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).
Time frame
Baseline - 16 weeksSecondary outcomes
1
Difference in the ALSFRS-R between groups at 32 weeks and 48 weeks
Difference in the ALS Functional Rating Scale-Revised (ALSFRS-R) between groups at 32 weeks and 48 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).
Time frame
32 weeks - 48 weeks2
Difference in the ALSAQ-40 between groups
Difference in the Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 score (ALSAQ-40) from baseline.The Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ) is a patient self-report health status scale. The ALSAQ is specifically used to measure the subjective well-being of patients with amyotrophic lateral sclerosis. There are 40 items/questions with 5 discrete scales: physical mobility (10 items), activities of daily living and independence (10 items), eating and drinking (3 items), communication (7 items), emotional reactions (10 items). Patients are asked to think about the difficulties they may have experienced during the last two weeks (e.g. I have found it difficult to feed myself). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never/rarely/sometimes/often/always or cannot do at all. The total ranges from 0 (no impairment) to 160 (severe impairment).
Time frame
Baseline - 16 weeks - 32 weeks - 48 weeks3
Difference in the Caregiver Burden Inventory (CBI) score between groups
Difference in the Caregiver Burden Inventory (CBI) score between groups from baseline.The CBI scale is 24- item scale designed to assess the experience of caregivers of older people. The multidimensional instrument assesses five domains of burden (time-dependence, developmental, physical, social, and emotional). Items are scored on a 4-point scale, ranging from "not at all descriptive" to "very descriptive". The scale ranges from 0 (no impairment) to 96 (severe impairment).
Time frame
Baseline - 16 weeks - 32 weeks - 48 weeks4
Difference in Quality of Life EQ-5D-5L Scale between groups
Difference in Quality of Life EQ-5D-5L Scale between groups from baseline.The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The scale ranges from 5 (no impairment) to 25 (severe impairment).
Time frame
Baseline - 16 weeks - 32 weeks - 48 weeksSponsors and contacts
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Source ClinicalTrials.gov