Amyotrophic lateral sclerosis
Conditions
Interventions
This is a randomized, controlled, crossover, double-blind, 1:1 allocation proof-of-concept clinical trial involving approximately 20 participants, distributed between individuals with amyotrophic late
Sponsors
Departamento de Fisioterapia
Departamento de Fisioterapia
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Individuals diagnosed with amyotrophic lateral sclerosis according to the Gold Coast criteria; age between 18 and 80 years; both sexes; adequate cognitive performance defined by a score =17 on the ALS Cognitive Behavioral Screen; ability to perform functional movements of the upper limbs; neurotypical individuals without a diagnosis of neurological disease; age between 18 and 80 years; both sexes; adequate cognitive performance defined by a score =17 on the ALS Cognitive Behavioral Screen; ability to perform functional movements of the upper limbs
Exclusion criteria
Exclusion criteria: Presence of neuropsychiatric disorders; history of seizures or epilepsy; history of traumatic brain injury; presence of metallic clips, pacemakers, or deep brain stimulation implants; history of neurosurgery; alcohol abuse or drug dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that upper limb muscle activity will be modulated after the application of high-definition transcranial direct current stimulation (HD-tDCS). This outcome will be verified by surface electromyography (EMG), using the TRIGNO™ Wireless system (Delsys Inc.), during standardized functional tasks of the upper limbs. The parameters used to confirm the outcome include the amplitude and frequency of the electromyographic signal, analyzed in the pre- and post-intervention periods, at rest and during the execution of motor tasks.;Changes in motor cortical excitability are expected after the application of HD-tDCS.This outcome will be verified by transcranial magnetic stimulation (TMS), applied to the bilateral primary motor cortex. The parameters used to confirm the outcome include the resting and active motor threshold, the amplitude and latency of the evoked motor potential, the cortical silence period, as well as measures of intracortical inhibition and facilitation, assessed before and after each experimental session. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cortical connectivity and oxygenation are expected to be observed after the application of HD-tDCS. This outcome will be verified by functional near-infrared spectroscopy (fNIRS), with continuous recording during the pre-, during, and post-stimulation periods. The parameters used to confirm the outcome include variations in oxygenated (HbO) and deoxygenated (HbR) hemoglobin concentrations, as well as measures of inter- and intra-hemispheric connectivity in motor and sensorimotor regions.;It is expected that changes in cortical electrical activity will be identified after the application of HD-tDCS. This outcome will be verified by means of resting electroencephalography (EEG), recorded before and after the active and sham stimulation sessions. The parameters used to confirm the outcome include spectral power in the delta, theta, alpha, and beta bands, as well as functional connectivity metrics, with emphasis on sensorimotor regions.;The tolerability and safety of HD-tDCS application in study participants are expected to be evaluated. This outcome will be verified through monitoring vital signs and applying a standardized sensation scale after each experimental session. The parameters used to confirm the outcome include the presence, intensity, and frequency of adverse effects reported during and after the interventions. | — |
Countries
Brazil
Contacts
Public ContactEricka Serafini
Universidade Federal do Rio Grande do Norte
Outcome results
None listed