High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Brazil
Universidade de Brasília - Campus Ceilândia
RECRUITING
Brasília
PneumoCardioVascular Lab - HUOL/UFRN
RECRUITING
Natal
Chile
Universidad Autónoma de Chile
NOT_YET_RECRUITING
Santiago
Universidad do Chile
NOT_YET_RECRUITING
Santiago
Contact Information
Primary
Guilherme A. F Fregonezi, PhD
guilherme.fregonezi@ufrn.br
+55(84)99426-7896
Backup
Edna K. F Laurentino, MSc
ednakarlaferreira@gmail.com
+55(84)99471-5172
Time Frame
Start Date: 2025-11-28
Estimated Completion Date: 2027-12
Participants
Target number of participants: 80
Treatments
Experimental: Active HD-tDCS Group
Patients randomly included in this group will receive 10 sessions of anodal HD-tDCS stimulation. The intervention will take place at the participant's home, with electrodes positioned in a circular arrangement-one central electrode and four peripheral electrodes-over the cortical representation zone of the left primary diaphragmatic motor cortex, with a continuous current applied
Placebo_comparator: HD-tDCS sham group
Patients randomly included in this group will receive 10 sessions of sham HD-tDCS stimulation. The intervention will take place at the participant's home, with electrodes positioned in a circular arrangement-one central electrode and four peripheral electrodes-over the cortical representation zone of the left primary diaphragmatic motor cortex. Only an initial 30-second ramp stimulus will be applied, followed by a non-effective current
Related Therapeutic Areas
Sponsors
Collaborators: Financiadora de Estudos e Projetos
Leads: Universidade Federal do Rio Grande do Norte