NCT03293394: tDCS_MND

Rehabilitative Trial With tDCS in Amyotrophic Lateral Sclerosis

Completed NA Results posted Last updated 3 March 2020

What this trial tests

NA trial testing Anodal bilateral motor cortex and cathodal spinal tDCS in Amyotrophic Lateral Sclerosis in 30 participants. Completed in 1 July 2018.

Timeline

2 October 2017

Primary endpoint
20 June 2018

1 July 2018

Quick facts

Lead sponsor	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	2 October 2017
Primary completion	20 June 2018
Estimated completion	1 July 2018
Sites	1 location across Italy

Drugs / interventions tested

• Anodal bilateral motor cortex and cathodal spinal tDCS
• Sham bilateral motor cortex and sham spinal tDCS

Conditions studied

• Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — full company profile →

Who can join

Adults 18 to 85, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Muscle Strength From Baseline Primary · Baseline - 2 weeks - 2 months - 6 months

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).

Baseline

Group	Value	95% CI
Real tDCS	74.7	± 0.0
Sham tDCS	74.7	± 0.0

2 Weeks

Group	Value	95% CI
Real tDCS	76.4	± 0.2
Sham tDCS	74.5	± 0.3

2 Months

Group	Value	95% CI
Real tDCS	76.4	± 0.4
Sham tDCS	72.9	± 0.6

6 Months

Group	Value	95% CI
Real tDCS	75.9	± 0.6
Sham tDCS	72.0	± 0.9

Change in Short-interval Intracortical Inhibition (SICI) From Baseline Secondary · Baseline - 2 weeks - 2 months - 6 months

By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on short-interval intracortical inhibition (SICI) from baseline

Baseline

Group	Value	95% CI
Real tDCS	1.0	± 0.1
Sham tDCS	1.0	± 0.1

2 weeks

Group	Value	95% CI
Real tDCS	0.4	± 0.1
Sham tDCS	1.0	± 0.1

2 Months

Group	Value	95% CI
Real tDCS	0.5	± 0.1
Sham tDCS	0.9	± 0.1

6 Months

Group	Value	95% CI
Real tDCS	0.6	± 0.1
Sham tDCS	1.0	± 0.1

Change in the ALSFRS-R Score From Baseline Secondary · Baseline - 2 weeks - 2 months - 6 months

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 imp

Baselin

Group	Value	95% CI
Real tDCS	31.5	± 0.0
Sham tDCS	31.5	± 0.0

2 Weeks

Group	Value	95% CI
Real tDCS	32.5	± 0.2
Sham tDCS	31.8	± 0.3

2 Months

Group	Value	95% CI
Real tDCS	32.0	± 0.4
Sham tDCS	30.4	± 0.5

6 Months

Group	Value	95% CI
Real tDCS	30.4	± 0.5
Sham tDCS	29.7	± 0.7

Change of Quality of Life From Baseline: ALSAQ-40 Scale Secondary · Baseline - 2 weeks - 2 months - 6 months

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 expe

Baseline

Group	Value	95% CI
Real tDCS	45.0	± 0.0
Sham tDCS	45.0	± 0.0

2 Weeks

Group	Value	95% CI
Real tDCS	40.1	± 2.0
Sham tDCS	38.3	± 2.8

2 Months

Group	Value	95% CI
Real tDCS	38.8	± 1.8
Sham tDCS	41.0	± 2.5

6 Months

Group	Value	95% CI
Real tDCS	41.9	± 2.2
Sham tDCS	42.4	± 3.1

Change of Quality of Life From Baseline: EQ-5D-5L Scale Secondary · Baseline - 2 weeks - 2 months - 6 months

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).

Baseline

Group	Value	95% CI
Real tDCS	13.0	± 0.0
Sham tDCS	13.0	± 0.0

2 Weeks

Group	Value	95% CI
Real tDCS	12.2	± 0.5
Sham tDCS	13.6	± 0.8

2 Months

Group	Value	95% CI
Real tDCS	12.6	± 0.5
Sham tDCS	14.2	± 0.7

6 Months

Group	Value	95% CI
Real tDCS	13.3	± 0.6
Sham tDCS	14.3	± 0.9

Change of Quality of Life From Baseline: EQ-VAS Scale Secondary · Baseline - 2 weeks - 2 months - 6 months

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).

Baseline

Group	Value	95% CI
Real tDCS	51.6	± 0.0
Sham tDCS	51.6	± 0.0

2 Weeks

Group	Value	95% CI
Real tDCS	56.3	± 2.0
Sham tDCS	46.1	± 2.8

2 Months

Group	Value	95% CI
Real tDCS	53.2	± 2.2
Sham tDCS	42.7	± 3.1

6 Months

Group	Value	95% CI
Real tDCS	54.7	± 2.9
Sham tDCS	40.2	± 4.0

Change in Caregiver Burden (CBI) Secondary · Baseline - 2 weeks - 2 months - 6 months

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).

Baseline

Group	Value	95% CI
Real tDCS	26.7	± 0.0
Sham tDCS	26.7	± 0.0

2 Weeks

Group	Value	95% CI
Real tDCS	21.6	± 1.1
Sham tDCS	30.0	± 1.5

2 Months

Group	Value	95% CI
Real tDCS	24.0	± 1.4
Sham tDCS	30.4	± 1.9

6 Months

Group	Value	95% CI
Real tDCS	24.8	± 1.3
Sham tDCS	30.7	± 1.9

Change Intracortical Facilitation (ICF) From Baseline Secondary · Baseline - 2 weeks - 2 month - 6 months

By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on intracortical facilitation (ICF) from baseline

Baselin

Group	Value	95% CI
Real tDCS	1.8	± 0.1
Sham tDCS	1.7	± 0.1

2 Weeks

Group	Value	95% CI
Real tDCS	1.3	± 0.0
Sham tDCS	1.7	± 0.1

2 Months

Group	Value	95% CI
Real tDCS	1.4	± 0.1
Sham tDCS	1.7	± 0.1

6 Months

Group	Value	95% CI
Real tDCS	1.6	± 0.0
Sham tDCS	1.6	± 0.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 Months follow-up. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Real tDCS

Serious: 4/20 (20%)

Deaths: 0/20

Sham tDCS

Serious: 2/10 (20%)

Deaths: 0/10

Serious adverse events (3 terms)

Reaction	System	Real tDCS	Sham tDCS
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—
Worsening of Global Clinical Conditions	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Pneumonia, Respiratory Failure, Worsening of Global Clinical Conditions.

Data from ClinicalTrials.gov NCT03293394 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.