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

NCT06719947

RecruitingPhase 2, Phase 3

Sponsor: Universidade Federal do Rio Grande do Norte

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Interventions: Active HD-tDCS, Simulated HD-tDCS

Countries: Brazil, Chile

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (4)

Brasília, Federal District, Brazil
Natal, Rio Grande do Norte, Brazil
Santiago, Santiago Metropolitan, Chile
Santiago, Santiago Metropolitan, Chile