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Recruiting NCT06719947

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

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 80
Sponsor: Universidade Federal do Rio Grande do Norte

Location: Universidade de Brasília - Campus Ceilândia Brasília Federal District

Summary

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.

Eligibility Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06719947). StuddyBuddy aggregates publicly available trial information.