An interventional study of Anodal bilateral motor cortex and cathodal spinal tDCS and Sham bilateral motor cortex and sham spinal tDCS in Amyotrophic Lateral Sclerosis, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Not applicable, Interventional, and Treatment
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Among 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy — 27 open to participants now, 36 under way, 7 of them phase 3. Amyotrophic Lateral Sclerosis · Italy.
Among the 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy, this one is the 64th largest by enrollment of the 69 interventional ones that give a count, is one of 6 that started in 2017, is one of 18 with no phase, and was the 25th registered.
979 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 278 are open to participants now.
Browse Amyotrophic Lateral Sclerosis studies →27 of the 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy are open now. Recruiting first, the newest first:
Leal Therapeutics, Inc · Sites in Italy, Germany, Netherlands and 1 more country
Ages 18–75
Prilenia · Sites in Italy, United States, Belgium and 10 more countries
Ages 18–80
Istituto Auxologico Italiano · Sites in Italy
Ages 18+
Zydus Therapeutics Inc. · Sites in Italy, United States, Australia and 9 more countries
Ages 18+
University of Trieste · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 193 Amyotrophic Lateral Sclerosis studies recruiting now, 118 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
89 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 26 · Phase 3 24 · Phase 4 2
First in 2003; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 38 across 663 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Median enrollment 87 across the 69 interventional studies, 200 across the 20 observational. Of the 46 that completed or were terminated, 23 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 89 have an industry lead sponsor. The 10 most frequent:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia has 2 studies filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
11 of the studies in Amyotrophic Lateral Sclerosis with a site in Italy that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06126315Phase 3Mario Negri Institute for Pharmacological ResearchTrial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS | 2027-04 |
| NCT04856982Phase 3BiogenStudy to Learn If Tofersen (BIIB067) Can Delay ALS Symptoms and About Its Safety in Adults With a SOD1 Gene Mutation Who Have Not Yet Developed ALS Symptoms | 2027-08-07 |
| NCT06881979Istituti Clinici Scientifici Maugeri SpAHigh-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases - Fit4MedRob-Chronic MND Project | 2026-11 |
| NCT07616050Marta MondelliniEvaluation of the Impact of Virtual Park on Training Motivation in Adult Patients | 2026-12 |
| NCT06318585Istituto Auxologico ItalianoCreation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases | 2026-12-31 |
Add all 11 to your calendar (.ics) → With an account.
Among the 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression.
Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures.
In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate intracortical connectivity, at short and long term.
Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression.
Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures.
In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate intracortical connectivity, at short and long term.
Subjects will be randomized in two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal bilateral motor cortex tDCS and cathodal spinal tDCS and the other receiving sham stimulation with identical parameters. After the intervention, patients will be reassessed with a clinical and neurophysiological evaluation at 2 weeks, 2 months and 6 months after treatment. Furthermore, blood neurofilaments will be measured at each time point.
Clinical evaluation will include the ALSFRS-R, ALSAQ-40, CBI, EQ-5D-5L, muscle strength evaluated with the MRC scale.
Neurophysiological evaluation will include measures of intracortical connectivity, evaluated with transcranial magnetic stimulation (TMS) as short interval intracortical inhibition (SICI-ICF), long interval intracortical inhibition (LICI), short interval intracortical facilitation (SICF).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 days anodal bilateral motor cortex and cathodal spinal tDCS
Device: Anodal bilateral motor cortex and cathodal spinal tDCS
10 days sham bilateral motor cortex and sham spinal tDCS
Device: Sham bilateral motor cortex and sham spinal tDCS
10 sessions of anodal bilateral motor cortex and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)
10 sessions of sham bilateral motor cortex and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)
Change in Muscle Strength From Baseline
A megascore is obtained by summing scores of single muscles (shoulder abductors, elbow flexors and extensors, wrist flexors, thumb opponent, hip flexors, knee flexors and extensors, and ankle dorsiflexors and extensors on both sides) manually evaluated according to the Medical Research Council (MRC) scale, which ranges from 0 (no movement) to 5 (normal contraction). The score for each muscle is summed, with scores ranging from 100 (no impairment) to 0 (most severe impairment).
Time frame: Baseline - 2 weeks - 2 months - 6 months
Change in Short-interval Intracortical Inhibition (SICI) From Baseline
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on short-interval intracortical inhibition (SICI) from baseline
Time frame: Baseline - 2 weeks - 2 months - 6 months
Change in the ALSFRS-R Score From Baseline
Change in the ALS Functional Rating Scale (ALSFRS-R) score from baseline. 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 - 2 weeks - 2 months - 6 months
Change of Quality of Life From Baseline: ALSAQ-40 Scale
Change of quality of life from baseline evaluated with the ALSAQ-40 scale. 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 - 2 weeks - 2 months - 6 months
Change of Quality of Life From Baseline: EQ-5D-5L Scale
Change of quality of life from baseline evaluated with the EQ-5D-5L scale. 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 - 2 weeks - 2 months - 6 months
Change of Quality of Life From Baseline: EQ-VAS Scale
Change of quality of life from baseline evaluated with the EQ-VAS scale. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. The scale ranges from 0 (severe impairment) to 100 (no impairment).
Time frame: Baseline - 2 weeks - 2 months - 6 months
Change in Caregiver Burden (CBI)
Change of quality of life from baseline evaluated with the CBI scale. 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 - 2 weeks - 2 months - 6 months
Change Intracortical Facilitation (ICF) From Baseline
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on intracortical facilitation (ICF) from baseline
Time frame: Baseline - 2 weeks - 2 month - 6 months
| Milestone | Real tDCS | Sham tDCS |
|---|---|---|
| Started | 20 | 10 |
| Completed | 20 | 10 |
| Not completed | 0 | 0 |
| Milestone | Real tDCS | Sham tDCS |
|---|---|---|
| Started | 20 | 10 |
| Completed | 16 | 8 |
| Not completed | 4 | 2 |
| Withdrew: Adverse event | 4 | 2 |
A megascore is obtained by summing scores of single muscles (shoulder abductors, elbow flexors and extensors, wrist flexors, thumb opponent, hip flexors, knee flexors and extensors, and ankle dorsiflexors and extensors on both sides) manually evaluated according to the Medical Research Council (MRC) scale, which ranges from 0 (no movement) to 5 (normal contraction). The score for each muscle is summed, with scores ranging from 100 (no impairment) to 0 (most severe impairment).
| units on a scale | Real tDCS | Sham tDCS |
|---|---|---|
| Baseline | 74.7 ± 0.0 | 74.7 ± 0.0 |
| 2 Weeks | 76.4 ± 0.2 | 74.5 ± 0.3 |
| 2 Months | 76.4 ± 0.4 | 72.9 ± 0.6 |
| 6 Months | 75.9 ± 0.6 | 72.0 ± 0.9 |
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on short-interval intracortical inhibition (SICI) from baseline
| millivolts | Real tDCS | Sham tDCS |
|---|---|---|
| Baseline | 1.0 ± 0.1 | 1.0 ± 0.1 |
| 2 weeks | 0.4 ± 0.1 | 1.0 ± 0.1 |
| 2 Months | 0.5 ± 0.1 | 0.9 ± 0.1 |
| 6 Months | 0.6 ± 0.1 | 1.0 ± 0.1 |
Change in the ALS Functional Rating Scale (ALSFRS-R) score from baseline. 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).
| units on a scale | Real tDCS | Sham tDCS |
|---|---|---|
| Baselin | 31.5 ± 0.0 | 31.5 ± 0.0 |
| 2 Weeks | 32.5 ± 0.2 | 31.8 ± 0.3 |
| 2 Months | 32.0 ± 0.4 | 30.4 ± 0.5 |
| 6 Months | 30.4 ± 0.5 | 29.7 ± 0.7 |
Change of quality of life from baseline evaluated with the ALSAQ-40 scale. 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).
| units on a scale | Real tDCS | Sham tDCS |
|---|---|---|
| Baseline | 45.0 ± 0.0 | 45.0 ± 0.0 |
| 2 Weeks | 40.1 ± 2.0 | 38.3 ± 2.8 |
| 2 Months | 38.8 ± 1.8 | 41.0 ± 2.5 |
| 6 Months | 41.9 ± 2.2 | 42.4 ± 3.1 |
Change of quality of life from baseline evaluated with the EQ-5D-5L scale. 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).
| units on a scale | Real tDCS | Sham tDCS |
|---|---|---|
| Baseline | 13.0 ± 0.0 | 13.0 ± 0.0 |
| 2 Weeks | 12.2 ± 0.5 | 13.6 ± 0.8 |
| 2 Months | 12.6 ± 0.5 | 14.2 ± 0.7 |
| 6 Months | 13.3 ± 0.6 | 14.3 ± 0.9 |
Change of quality of life from baseline evaluated with the EQ-VAS scale. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. The scale ranges from 0 (severe impairment) to 100 (no impairment).
| units on a scale | Real tDCS | Sham tDCS |
|---|---|---|
| Baseline | 51.6 ± 0.0 | 51.6 ± 0.0 |
| 2 Weeks | 56.3 ± 2.0 | 46.1 ± 2.8 |
| 2 Months | 53.2 ± 2.2 | 42.7 ± 3.1 |
| 6 Months | 54.7 ± 2.9 | 40.2 ± 4.0 |
Change of quality of life from baseline evaluated with the CBI scale. 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).
| units on a scale | Real tDCS | Sham tDCS |
|---|---|---|
| Baseline | 26.7 ± 0.0 | 26.7 ± 0.0 |
| 2 Weeks | 21.6 ± 1.1 | 30.0 ± 1.5 |
| 2 Months | 24.0 ± 1.4 | 30.4 ± 1.9 |
| 6 Months | 24.8 ± 1.3 | 30.7 ± 1.9 |
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on intracortical facilitation (ICF) from baseline
| millivolts | Real tDCS | Sham tDCS |
|---|---|---|
| Baselin | 1.8 ± 0.1 | 1.7 ± 0.1 |
| 2 Weeks | 1.3 ± 0.0 | 1.7 ± 0.1 |
| 2 Months | 1.4 ± 0.1 | 1.7 ± 0.1 |
| 6 Months | 1.6 ± 0.0 | 1.6 ± 0.1 |
Collected over 6 Months follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Real tDCS | 0/20 (0%) | 4/20 (20%) | 0/20 (0%) |
| Sham tDCS | 0/10 (0%) | 2/10 (20%) | 0/10 (0%) |
| Event | Real tDCS | Sham tDCS |
|---|---|---|
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/20 | 2/10 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 2/20 | 0/10 |
| Worsening of Global Clinical ConditionsMusculoskeletal and connective tissue disorders | 1/20 | 0/10 |
Baseline analysis are reported for 30 participants who completed the first intervention.
| Age, Continuous(years) | Real tDCS | Sham tDCS | Total |
|---|---|---|---|
| Mean | 60.5 ± 10.9 | 63.9 ± 11.3 | 61.7 ± 2.0 |
| Sex: Female, Male(Participants) | Real tDCS | Sham tDCS | Total |
|---|---|---|---|
| Female | 7 | 2 | 9 |
| Male | 13 | 8 | 21 |
| Race (NIH/OMB)(Participants) | Real tDCS | Sham tDCS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 20 | 10 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Real tDCS | Sham tDCS | Total |
|---|---|---|---|
| Italy | 20 | 10 | 30 |
| Disease Duration(years) | Real tDCS | Sham tDCS | Total |
|---|---|---|---|
| Mean | 2.1 ± 1.4 | 1.8 ± 1.0 | 2.0 ± 0.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Jun 2018, 8 months.
Results were first posted in Nov 2019, 1 year 5 months after primary completion.
Of 134 non-industry interventional studies with no phase under Amyotrophic Lateral Sclerosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's 8 months is below that.
Counting every sponsor, half of 154 studies reached it within 35 months; a quarter within 23 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis →
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia