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Recruiting NCT06719947

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

Phase II / Phase III Interventional Amyotrophic Lateral Sclerosis (ALS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active HD-tDCS, Simulated HD-tDCS.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis (ALS). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil, Chile
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial

Overview

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.

Detailed description

A multicenter, randomized controlled clinical trial will be conducted. Participants will be randomized into two groups: the HD-tDCS group (gTDCS) and the sham tDCS group (gSham). The intervention protocol will assess the effects of HD-tDCS on respiratory parameters and ALS progression. The study will include individuals of both sexes, aged 18 to 80 years, with a clinical diagnosis of ALS, evaluated before, during, and after the home-based HD-tDCS protocol. The electrodes will be positioned in a circular arrangement over the primary diaphragmatic motor cortex, applying a continuous anodal current intensity. For placebo comparison, only an initial 30-second ramp stimulus will be applied, followed by a minimal current, resulting in no significant intervention. The intervention will be conducted at the participant's home, once daily, five days per week, for two weeks. Patients will undergo evaluations of lung function, cough peak flow, respiratory muscle strength, nasal respiratory pressures, functional capacity, muscle fatigue, cognitive function, as well as surface electromyography of respiratory muscles during active and assisted breathing curves using transcranial magnetic stimulation (TMS), cortical excitability, central tissue oxygenation, respiratory muscle tissue oxygenation, functionality and disease progression, motor control and muscle performance, fatigue and dyspnea, sleep analysis, quality of life, and adverse effects.

Interventions

  • Device Active HD-tDCS
    10 sessions of anodal HD-tDCS stimulation (neurostimulator coupled with a 4x1 HD-tDCS multichannel adapter) with a defined electrical current intensity over the cortical representation zone of the left diaphragmatic motor cortex
  • Device Simulated HD-tDCS
    10 sessions of sham anodal HD-tDCS stimulation (neurostimulator coupled with a 4x1 HD-tDCS multichannel adapter) over the cortical representation zone of the left diaphragmatic motor cortex. The device will provide a 30-second ramp and then maintain a minimal, non-effective continuous current

Primary outcome measures

  • Cortical excitability assessed via TMS [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Cortical tissue oxygenation [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Electromyographic activity of specific respiratory muscles [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
Secondary outcome measures (11)
  • Respiratory function assessed by spirometry [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Maximum Inspiratory and Expiratory Pressure [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Cough Peak Flow [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Respiratory muscle oxygenation via near-infrared spectroscopy [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Peripheral upper limb muscle activity assessed via electromyography [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Functionality and disease progression [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Fatigue Severity [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Dyspnea assessed via Modified Borg Scales [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Quality of sleep assessment [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Quality of life assessed using the Brief ALS-specific Quality of Life Questionnaire [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]
  • Subjective assessment of stimulation-related effects [Time frame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Brazil · 2 centers
  • Universidade de Brasília - Campus Ceilândia — Brasília
  • PneumoCardioVascular Lab - HUOL/UFRN — Natal
Chile · 2 centers
  • Universidad Autónoma de Chile — Santiago
  • Universidad do Chile — Santiago

Identifiers

NCT: NCT06719947 · HD-tDCSALS · U1111-1306-808

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗