Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Rehabilitative Trial With Transcranial Direct Current Stimulation (tDCS) in Amyotrophic Lateral Sclerosis
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04428775 -
A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease
|
Phase 2 | |
| Recruiting |
NCT04998305 -
TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05951556 -
Telehealth Implementation of Brain-Computer Interface
|
N/A | |
| Terminated |
NCT04579666 -
MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| Recruiting |
NCT04082832 -
CuATSM Compared With Placebo for Treatment of ALS/MND
|
Phase 2/Phase 3 | |
| Completed |
NCT01925196 -
Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
|
||
| Completed |
NCT02496767 -
Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year
|
Phase 3 | |
| Recruiting |
NCT04816227 -
Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
|
||
| Active, not recruiting |
NCT04494256 -
A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation
|
Phase 1/Phase 2 | |
| Completed |
NCT03706391 -
Study of ALS Reversals 4: LifeTime Exposures
|
||
| Recruiting |
NCT04882904 -
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.
|
N/A | |
| Completed |
NCT04557410 -
Open Label Study: Treatment of ALS Fatigue With PolyMVA
|
Phase 1 | |
| Active, not recruiting |
NCT04948645 -
A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis
|
Phase 1 | |
| Not yet recruiting |
NCT04089696 -
Validation of the "ExSpiron©" in Patients With ALS
|
N/A | |
| Not yet recruiting |
NCT04220190 -
RAPA-501 Therapy for ALS
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05860244 -
Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients
|
Phase 2 | |
| Not yet recruiting |
NCT06450691 -
Modeling Amyotrophic Lateral Sclerosis With Fibroblasts
|
N/A | |
| Recruiting |
NCT02917681 -
Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03067857 -
Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02874209 -
Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis
|
N/A |