N/A
N=30
Rehabilitative Trial With tDCS in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03293394 ↗Enrolled (actual)
30
Serious AEs
20.0%
Results posted
Nov 2019
Primary outcome: Primary: Change in Muscle Strength From Baseline — 74.7; 74.7; 76.4; 74.5 units on a scale — p==0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anodal bilateral motor cortex and cathodal spinal tDCS (Device); Sham bilateral motor cortex and sham spinal tDCS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Muscle Strength From Baseline |
74.7; 74.7; 76.4; 74.5; 76.4; 72.9 | =0.001 sig |
| SECONDARY Change in Short-interval Intracortical Inhibition (SICI) From Baseline |
1.0; 1.0; 0.4; 1.0; 0.5; 0.9 | 0.011 sig |
| SECONDARY Change in the ALSFRS-R Score From Baseline |
31.5; 31.5; 32.5; 31.8; 32.0; 30.4 | 0.190 |
| SECONDARY Change of Quality of Life From Baseline: ALSAQ-40 Scale |
45.0; 45.0; 40.1; 38.3; 38.8; 41.0 | 0.652 |
| SECONDARY Change of Quality of Life From Baseline: EQ-5D-5L Scale |
13.0; 13.0; 12.2; 13.6; 12.6; 14.2 | 0.190 |
| SECONDARY Change of Quality of Life From Baseline: EQ-VAS Scale |
51.6; 51.6; 56.3; 46.1; 53.2; 42.7 | 0.011 sig |
| SECONDARY Change in Caregiver Burden (CBI) |
26.7; 26.7; 21.6; 30.0; 24.0; 30.4 | 0.003 sig |
| SECONDARY Change Intracortical Facilitation (ICF) From Baseline |
1.8; 1.7; 1.3; 1.7; 1.4; 1.7 | 0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria
- Disease duration ≤ 24 months
- Disease progression in the past 3 months
- Score ≥ 2 at the item "swallowing" of the ALS Functional Rating Scale Revised
- Score ≥ 2 at the item "walking" of the ALS Functional Rating Scale Revised
- Treatment with steady regimen of riluzole for a minimum of 1 month before study entry, and desiring its continuation
- Able to give informed consent
- Written informed consent
Exclusion Criteria
- Motor neuron diseases other than ALS
- Severe head trauma in the past
- History of seizures
- History of ischemic stroke or hemorrhage
- Pacemaker
- Metal implants in the head/neck region
- Severe comorbidity
- Intake of illegal drugs
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03293394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.