Amyotrophic Lateral Sclerosis (ALS)Phase 2/3tDCS-ALSNCT06719947
HD-tDCS in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial
A Phase 2/3 study testing Active HD-tDCS and Simulated HD-tDCS in people with Amyotrophic Lateral Sclerosis (ALS), run by Universidade Federal do Rio Grande do Norte at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Active HD-tDCS and Simulated HD-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 28 Nov 2025to 1 Sep 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Brazil2 sites, 2 recruiting
- Recruiting
Universidade de Brasília - Campus Ceilândia
Brasília, Federal District, 72220-275
Vinicius Z Maldaner da Silva, PhD, +55 61 99652-2517, pneumocardiovascularlab@gmail.com
Vinicius Z Maldaner da Silva, PhD
- Recruiting
PneumoCardioVascular Lab - HUOL/UFRN
Natal, Rio Grande do Norte, 59010-090
Guilherme A. F Fregonezi, PhD, +55 84 3092-3624 ext. 3624, pneumocardiovascularlab@gmail.com
Edna K Ferreira Laurentino, MSc, +55 084 99471-5172, ednakarlaferreira@gmail.com
Chile2 sites, 2 recruiting
- Not yet recruiting
Universidad Autónoma de Chile
Santiago, Santiago Metropolitan, 7500912
Matias Otto Yañez, PhD, +56 9 8885-6626, matiasotto.kine@gmail.com
Matias Otto Yañez, PhD, +56 9 8885-6626
- Not yet recruiting
Universidad do Chile
Santiago, Santiago Metropolitan, 8380453
Roberto Vera Uribe, MsC, robertovera@uchile.cl
Rodrigo Torres Castro, MsC, klgorodrigotorres@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Active HD-tDCS, Simulated HD-tDCS
- Keywords
- Amyotrophic Lateral Sclerosis (ALS), Central Nervous System Diseases, Electric Stimulation Therapy, Transcranial Direct Current Stimulation
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active HD-tDCSDevice
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
Simulated HD-tDCSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Active HD-tDCS Group | Experimental | 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 Receives: Device: Active HD-tDCS |
| HD-tDCS sham group | Placebo comparator | 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 Receives: Device: Simulated HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical excitability assessed via TMS
Cortical excitability assessed by means of Transcranial Magnetic Stimulation measuring motor evoked potentials, cortical inhibition and duration of the cortical silent period
Measured: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Cortical tissue oxygenation
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.
Measured: 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
This outcome will be assessed through Electromyography of the sternocleidomastoid, scalene, parasternal, hemidiaphragm and rectus abdominis muscles
Measured: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Secondary outcomes (11)
Respiratory function assessed by spirometry
This outcome will be assessed using spirometry
Measured: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Maximum Inspiratory and Expiratory Pressure
This outcome will be assessed by assessing maximum inspiratory and expiratory pressure, Sniff Nasal Inspiratory Pressure and Sniff Nasal Expiratory Pressure curves
Measured: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Cough Peak Flow
This outcome will be assessed through Cough Peak Flow values
Measured: 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
This outcome will be assessed using the near-infrared spectroscopy technique coupled to the scalene and parasternal muscles
Measured: 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
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
Measured: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Functionality and disease progression
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
Measured: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Fatigue Severity
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
Measured: 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
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
Measured: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Quality of sleep assessment
This outcome will be assessed using the Mini-Sleep Questionnaire
Measured: 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
This outcome will be assessed using the Brief Specific Quality of Life Questionnaire for ALS Patients
Measured: 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
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)
Measured: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start28 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Responsible party
- Principal investigator, Guilherme Augusto de Freitas Fregonezi, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719947
- Sponsor's protocol ID
- HD-tDCSALS
- Other IDs
- U1111-1306-808
- Acronym
- tDCS-ALS
- Status last verified
- Jul 2026
- First submitted
- 30 Nov 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06719947
- Acronym / sponsor ID
- tDCS-ALS / HD-tDCSALS
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Amyotrophic Lateral Sclerosis (ALS), Central Nervous System Diseases, Electric Stimulation Therapy, Transcranial Direct Current Stimulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Active HD-tDCS Group | Experimental | Device: Active HD-tDCSPatients 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 |
| HD-tDCS sham group | Placebo comparator | Device: Simulated HD-tDCSPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active HD-tDCS10 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 | Active HD-tDCS Group |
| Simulated HD-tDCS10 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 | Device | HD-tDCS sham group |
Primary outcome
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
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.
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
11 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Active HD-tDCS and Simulated HD-tDCS in people with Amyotrophic Lateral Sclerosis (ALS), run by Universidade Federal do Rio Grande do Norte at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guilherme A. F Fregonezi, PhD (+55(84)99426-7896, guilherme.fregonezi@ufrn.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.