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New treatment option for Amyotrophic Lateral Sclerosis (ALS)
Official title HD-tDCS in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06719947
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- people who are unable to understand or perform any of the study procedures;
- people who do not agree to participate or voluntarily request withdrawal from the study at any time;
- people with cardiac, respiratory, or musculoskeletal comorbidities;
- people using invasive mechanical ventilation;
- people with a tracheostomy;
- people with a pacemaker;
See the full eligibility 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.
- people who are unable to understand or perform any of the study procedures;
- people who do not agree to participate or voluntarily request withdrawal from the study at any time;
- people with cardiac, respiratory, or musculoskeletal comorbidities;
- people using invasive mechanical ventilation;
- people with a tracheostomy;
- people with a pacemaker;
- people with metallic brain implants or other electronic implants;
- people with a cochlear implant;
- people with epileptic activity or a history of epilepsy, or a family history of epilepsy;
- people with a history of stroke or tumor;
- people prone to severe hemodynamic fluctuations, acute infectious processes, and/or inflammatory conditions;
- Pregnant women at the time of recruitment;
- people who are unable to complete the intervention protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Brasília, Federal District, Brazil
- Natal, Rio Grande do Norte, Brazil
- Santiago, Santiago Metropolitan, Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brasília, Federal District, Brazil; Natal, Rio Grande do Norte, Brazil; Santiago, Santiago Metropolitan, Chile. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.