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

Locations

4
Brazil
Universidade de Brasília - Campus Ceilândia72220-275, BrasíliaFederal District, Brazil
PneumoCardioVascular Lab - HUOL/UFRN59010-090, NatalRio Grande do Norte, Brazil
Chile
Universidad Autónoma de Chile7500912, SantiagoSantiago Metropolitan, Chile
Universidad do Chile8380453, SantiagoSantiago Metropolitan, Chile

Sponsors and collaborators

Universidade Federal do Rio Grande do Norte

Lead sponsor

Financiadora de Estudos e Projetos

Collaborator