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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversidade Federal do Rio Grande do Norte

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Active HD-tDCS
  • Simulated HD-tDCS

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universidade Federal do Rio Grande do Norte

Lead sponsor

Financiadora de Estudos e Projetos

Collaborator