HD-tDCS in ALS: a multicenter test of diaphragmatic motor cortex stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized controlled trial compares active HD-tDCS with sham stimulation in adults with ALS. The treatment uses a circular electrode arrangement over the diaphragmatic motor cortex applied at home for two weeks, five days per week. Outcomes include lung function, respiratory muscle strength, functional capacity, sleep, quality of life, and various neurologic and electrophysiologic measures to track respiratory and disease progression. Participants are adults 18–80 with ALS and certain preserved respiratory function, enrolled at multiple international sites. The study explores whether noninvasive brain stimulation can modulate respiratory motor control in ALS patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universidade de Brasília - Campus Ceilândia
  Brasília, Federal District, Brazil Recruiting
• PneumoCardioVascular Lab - HUOL/UFRN
  Natal, Rio Grande do Norte, Brazil Recruiting
• Universidad Autónoma de Chile
  Santiago, Santiago Metropolitan, Chile Not yet recruiting
• Universidad do Chile
  Santiago, Santiago Metropolitan, Chile Not yet recruiting

Study contacts

• Study coordinator: Guilherme A. F Fregonezi, PhD
• Email: guilherme.fregonezi@ufrn.br
• Phone: +55(84)99426-7896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.