Cortico-Spinal tDCS as Rehabilitative Intervention in Amyotrophic Lateral: a Randomized, Double-blind, Sham-controlled Trial Followed by an Open-label Phase
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Motor Neuron Disease, Familial
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Change in Muscle Strength From Baseline
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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 followed by an open-label phase, the investigators will evaluate whether a repetition of two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS, after a six months interval, may further outlast clinical improvement in patients with amyotrophic lateral sclerosis and can modulate intracortical connectivity, at short and long term.
Detailed 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. The present randomized, double-blind, sham-controlled study followed by an open-label phase will investigate a repetition of two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS, after a six months interval, may further outlast clinical improvement in patients with amyotrophic lateral sclerosis and modulate intracortical connectivity, at short and long term.
Investigators
Barbara Borroni
Prof.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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
Outcomes
Primary Outcomes
Change in Muscle Strength From Baseline
Time Frame: Baseline - 2 weeks - 2 month - 6 months - 6 months and 2 weeks - 8 months - 12 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).
Secondary Outcomes
- Change in Caregiver Burden (CBI)(Baseline - 2 weeks - 2 month - 6 months - 6 months and 2 weeks - 8 months - 12 months)
- Change of Quality of Life From Baseline: ALSAQ-40 Scale(Baseline - 2 weeks - 2 month - 6 months - 6 months and 2 weeks - 8 months - 12 months)
- Change of Quality of Life From Baseline: EQ-VAS Scale(Baseline - 2 weeks - 2 month - 6 months - 6 months and 2 weeks - 8 months - 12 months)
- Change in Short-interval Intracortical Inhibition (SICI) From Baseline(Baseline - 2 weeks - 2 month - 6 months - 6 months and 2 weeks - 8 months - 12 months)
- Change in the ALSFRS-R Score From Baseline(Baseline - 2 weeks - 2 month - 6 months - 6 months and 2 weeks - 8 months - 12 months)
- Change Intracortical Facilitation (ICF) From Baseline(Baseline - 2 weeks - 2 month - 6 months - 6 months and 2 weeks - 8 months - 12 months)
- Change of Quality of Life From Baseline: EQ-5D-5L Scale(Baseline - 2 weeks - 2 month - 6 months - 6 months and 2 weeks - 8 months - 12 months)