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HD-tDCS in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial

RecruitingPhase 2, Phase 3Ages 18 Years - 80 YearsAllUniversidade Federal do Rio Grande do Norte
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In plain words

What the trial is, and whether it could suit you

Amyotrophic Lateral Sclerosis (ALS) is a nervous system disease that causes muscle weakness and rapidly progresses to the loss of mobility and functionality. Studies suggest that High-Definition Transcranial Direct Current Stimulation (HD-tDCS) is a technique for modulating motor cortical hyperexcitability. However, evidence on the use of HD-tDCS as a neuromodulator of the diaphragmatic motor cortex in people with ALS is inconclusive.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Both sexes; diagnosis of ALS according to the revised El Escorial criteria; * Age between 18 and 80 years; * Forced Vital Capacity greater than 50% of predicted; * Sniff nasal inspiratory pressure greater than 40 cmH2O; * A telephone number to contact the care team and who signed the study consent form. Exclusion Criteria: * Subjects who are unable to understand or perform any of the study procedures; * Subjects who do not agree to participate or voluntarily request withdrawal from the study at any time; * Subjects with cardiac, respiratory, or musculoskeletal comorbidities; * Subjects using invasive mechanical ventilation; * Subjects with a tracheostomy; * Subjects with a pacemaker; * Subjects with metallic brain implants or other electronic implants; * Subjects with a cochlear implant; * Subjects with epileptic activity or a history of epilepsy, or a family history of epilepsy; * Subjects with a history of stroke or tumor; * Subjects prone to severe hemodynamic fluctuations, acute infectious processes, and/or inflammatory conditions; * Pregnant women at the time of recruitment; * Subjects who are unable to complete the intervention protocol.
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What it tests

  • Active HD-tDCS
  • Simulated HD-tDCS
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Where

4 sites
Universidade de Brasília - Campus Ceilândia
Brasília, Brazil
PneumoCardioVascular Lab - HUOL/UFRN
Natal, Brazil
Universidad Autónoma de Chile
Santiago, Chile
Universidad do Chile
Santiago, Chile
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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