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

July 17, 2026 updated by: Guilherme Augusto de Freitas Fregonezi, Universidade Federal do Rio Grande do Norte

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • Federal District
      • Brasília, Federal District, Brazil, 72220-275
        • Recruiting
        • Universidade de Brasília - Campus Ceilândia
        • Contact:
        • Principal Investigator:
          • Vinicius Z Maldaner da Silva, PhD
        • Sub-Investigator:
          • Sergio R. M Mateus, PhD
        • Sub-Investigator:
          • Hamilton C Fernandes Franco, PhD
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59010-090
        • Recruiting
        • PneumoCardioVascular Lab - HUOL/UFRN
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guilherme A. F Fregonezi, PhD
        • Principal Investigator:
          • Ana Rodrigues Lindquist, PhD
        • Sub-Investigator:
          • Edna K Ferreira Laurentino, MSc
        • Sub-Investigator:
          • Wesley R Costa Meneses, BSc
        • Sub-Investigator:
          • Mario E Teixeira Dourado Junior, PhD
        • Sub-Investigator:
          • Lariza M da Costa, BSc
        • Sub-Investigator:
          • Vanessa R. F Resqueti, PhD
        • Sub-Investigator:
          • Danilo A. A Pinto Nagem, PhD
        • Sub-Investigator:
          • Mario E. T Dourado Junior, PhD
        • Sub-Investigator:
          • Suellen M. M dos Santos Andrade, PhD
        • Sub-Investigator:
          • Ricardo A de Medeiros Valentim, PhD
        • Sub-Investigator:
          • Rodrigo P de Abreu Freitas, PhD
        • Sub-Investigator:
          • Bruna R Carneiro de Sousa, MSc
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500912
        • Not yet recruiting
        • Universidad Autónoma de Chile
        • Contact:
        • Contact:
          • Matias Otto Yañez, PhD
          • Phone Number: +56 9 8885-6626
        • Principal Investigator:
          • Matias V Oto Yañez, PhD
      • Santiago, Santiago Metropolitan, Chile, 8380453
        • Not yet recruiting
        • Universidad do Chile
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roberto Vera Uribe, MsC
        • Principal Investigator:
          • Rodrigo Torres Castro, MsC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 excitability assessed by means of Transcranial Magnetic Stimulation measuring motor evoked potentials, cortical inhibition and duration of the cortical silent period
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)
Assessment of cortical tissue oxygenation using brain coupled near-infrared spectroscopy technique coupled to the brain to monitor cerebral oxygenation and regional cerebral oxygen saturation.
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)
This outcome will be assessed through Electromyography of the sternocleidomastoid, scalene, parasternal, hemidiaphragm and rectus abdominis muscles
From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
This outcome will be assessed using spirometry
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)
This outcome will be assessed by assessing maximum inspiratory and expiratory pressure, Sniff Nasal Inspiratory Pressure and Sniff Nasal Expiratory Pressure curves
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)
This outcome will be assessed through Cough Peak Flow values
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)
This outcome will be assessed using the near-infrared spectroscopy technique coupled to the scalene and parasternal muscles
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)
This outcome will be assessed through a protocol for assessing muscle activity positioned in the Lower Trapezius, Anterior Deltoid, Biceps Brachii (medial head), Triceps Brachii (lateral head), Brachioradialis, Extensor Carpi Radialis Longus, Abductor Pollicis Brevis and Upper Trapezius muscles, bilaterally
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)
This outcome will be assessed using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised which has 12 items with a score from zero to 4, and its total score can range from zero to 48, where 48 means normal functionality and zero, severe disability
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)
This outcome will be assessed using the Fatigue Severity Scale comprises nine statements ranging from 1 to 7, with 7 being the maximum level of agreement with the statement, with a minimum score of 9 and a maximum of 63, with values equal to or greater than 28 indicating fatigue
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)
The Modified Borg scale is numbered from 0 to 10, with each number referring to a textual description of the degree of respiratory fatigue, with 0 as the minimum and 10 as the maximum respiratory discomfort
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)
This outcome will be assessed using the Mini-Sleep Questionnaire
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)
This outcome will be assessed using the Brief Specific Quality of Life Questionnaire for ALS Patients
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)
This outcome will be assessed through a questionnaire about effects such as itching, tingling, redness of the skin, drowsiness, concentration problems, headache, fatigue, dizziness and others, indicating the intensity of these sensations on a scale of 1 to 4 (1 being none, 2 being mild, 3 being moderate and 4 being strong) and whether these effects are related to the stimulation, using a Likert scale from 1 (no relation) to 5 (strongly related)
From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Rio Grande do Norte

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Financiadora de Estudos e Projetos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HD-tDCSALS
  • U1111-1306-808 (Other Identifier: Universal Test Number (UTN))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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