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