Chronic Obstructive Pulmonary DiseaseNCT07831629
Clinical and Hemodynamic Correlates of Different Polarities of HD-tDCS in COPD
A study testing High-definition Transcranial Direct Current Stimulation in people with Chronic Obstructive Pulmonary Disease, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
The aim of this pilot randomized clinical trial is to identify the acute effects of HD-tDCS in the diaphragm cortex on cerebral hemodynamics in individuals with COPD. The main questions to answer are: Is there a change in cortical metabolism (HbO and OXYHb consumption) during and immediately after the application of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- High-definition Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Oct 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age over 18 years old;
- Airflow limitation mild to severe (GOLD 1-3);
- No contraindications for HD-tDCS, such as pregnancy, metal implants in the head, cochlear implants and pacemaker;
- Absence of concomitant diseases of the central or peripheral nervous system.
Who cannot join
- Refusal to sign the TCLE;
- Missing two consecutive or three alternate sessions during treatment;
- Develop any disabling condition that prevents continued participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Hemodynamic Correlates of Different Polarities of High-definition Transcranial Direct Current Stimulation in Chronic Respiratory Disease
The aim of this pilot randomized clinical trial is to identify the acute effects of HD-tDCS in the diaphragm cortex on cerebral hemodynamics in individuals with COPD.
The main questions to answer are:
Is there a change in cortical metabolism (HbO and OXYHb consumption) during and immediately after the application of HD-tDCS? Are there any particularities in cortical hemodynamics between the different HD-tDCS polarities? Participants will perform three HD-tDCS sessions, each one with a different type of stimulation (anodal, cathodal and sham) lasting for 20 minutes. Before, during and after stimulation, near-infrared spectrography will be used as assessment instruments.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- High-definition Transcranial Direct Current Stimulation, Sham High-definition Transcranial Direct Current Stimulation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition Transcranial Direct Current StimulationDevice
Also called HD-tDCS
Participants will receive stimulation through electrode positioning according to the International 10-20 System. The central electrode will be placed over the left diaphragm cortex, accompanied by four return electrodes. The current will be administered using a 3mA protocol for 20 minutes, with a 30-second ramp-up at the beginning and a 30-second ramp-down at the end of the stimulation for active groups. For the placebo group, the setup will remain identical; however, regarding the protocol, the device initially reaches a current of 3 mA and then drops to 0.1 mA within the first 30 seconds, remaining at this current for 20 minutes. A current of 3 mA will be reinstated only in the final 30 seconds, once again accompanied by ramp-up and ramp-down phases.
Sham High-definition Transcranial Direct Current StimulationOther
Also called Sham HD-tDCS
Participants received sham stimulation using the same electrode positioning as the active conditions (International 10-20 System), with a central electrode over the left diaphragm cortex and four return electrodes. The device initially reached a current of 3 mA and then dropped to 0.1 mA within the first 30 seconds, remaining at this current for 20 minutes. A current of 3 mA was reinstated only in the final 30 seconds, accompanied by ramp-up and ramp-down phases, replicating the initial and final sensations of active stimulation without delivering a sustained therapeutic current.
| Study group | Role | What they receive |
|---|---|---|
| anodal stimulation | Active comparator | Stimulation will be carried out in the diaphragm cortex with anodal current for 20 minutes. Before, during and after evaluation will be carried out with near infrared spectroscopy. Receives: Device: High-definition Transcranial Direct Current Stimulation |
| cathodal stimulation | Active comparator | Stimulation will be carried out in the diaphragm cortex with cathodal current for 20 minutes. Before, during and after evaluation will be carried out with near infrared spectroscopy. Receives: Device: High-definition Transcranial Direct Current Stimulation |
| sham stimulation | Placebo comparator | Placebo stimulation will be carried out in the diaphragm cortex for 20 minutes. Before, during and after evaluation will be carried out with near infrared spectroscopy. Receives: Other: Sham High-definition Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral hemodynamic response
Change in oxygenated (OxyHb) and deoxygenated (DeoxyHb) hemoglobin concentration measured by functional near-infrared spectroscopy (fNIRS)
Measured: Before, during, and after each 20-minute HD-tDCS session
Secondary outcomes (1)
respiratory muscle strength
Maximum inspiratory and expiratory pressure values, recorded using manovacuometry.
Measured: Immediately before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start5 Oct 2023
- Primary completion5 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Andrade, Federal University of Paraíba
- Investigators
- Suellen Andrade, PhD, Principal investigator, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831629
- Sponsor's protocol ID
- COPD-acute-hdtdcs
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2024
- Last updated
- 21 Sep 2026
- Results posted
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Hemodynamic Correlates of Different Polarities of High-definition Transcranial Direct Current Stimulation in Chronic Respiratory Disease
- ClinicalTrials.gov ID
- NCT07831629
- Acronym / sponsor ID
- COPD-acute-hdtdcs
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 21 Sep 2026 (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.
The aim of this pilot randomized clinical trial is to identify the acute effects of HD-tDCS in the diaphragm cortex on cerebral hemodynamics in individuals with COPD.
The main questions to answer are:
Is there a change in cortical metabolism (HbO and OXYHb consumption) during and immediately after the application of HD-tDCS? Are there any particularities in cortical hemodynamics between the different HD-tDCS polarities? Participants will perform three HD-tDCS sessions, each one with a different type of stimulation (anodal, cathodal and sham) lasting for 20 minutes. Before, during and after stimulation, near-infrared spectrography will be used as assessment instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anodal stimulation | Active comparator | Device: High-definition Transcranial Direct Current StimulationStimulation will be carried out in the diaphragm cortex with anodal current for 20 minutes. Before, during and after evaluation will be carried out with near infrared spectroscopy. |
| cathodal stimulation | Active comparator | Device: High-definition Transcranial Direct Current StimulationStimulation will be carried out in the diaphragm cortex with cathodal current for 20 minutes. Before, during and after evaluation will be carried out with near infrared spectroscopy. |
| sham stimulation | Placebo comparator | Other: Sham High-definition Transcranial Direct Current StimulationPlacebo stimulation will be carried out in the diaphragm cortex for 20 minutes. Before, during and after evaluation will be carried out with near infrared spectroscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years old;
- Airflow limitation mild to severe (GOLD 1-3);
- No contraindications for HD-tDCS, such as pregnancy, metal implants in the head, cochlear implants and pacemaker;
- Absence of concomitant diseases of the central or peripheral nervous system.
Key exclusion criteria (3 listed)
- Refusal to sign the TCLE;
- Missing two consecutive or three alternate sessions during treatment;
- Develop any disabling condition that prevents continued participation in the study.
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 |
|---|---|---|
| High-definition Transcranial Direct Current StimulationAlso: HD-tDCSParticipants will receive stimulation through electrode positioning according to the International 10-20 System. The central electrode will be placed over the left diaphragm cortex, accompanied by four return electrodes. The current will be administered using a 3mA protocol for 20 minutes, with a 30-second ramp-up at the beginning and a 30-second ramp-down at the end of the stimulation for active groups. For the placebo group, the setup will remain identical; however, regarding the protocol, the device initially reaches a current of 3 mA and then drops to 0.1 mA within the first 30 seconds, remaining at this current for 20 minutes. A current of 3 mA will be reinstated only in the final 30 seconds, once again accompanied by ramp-up and ramp-down phases. | Device | anodal stimulation, cathodal stimulation |
| Sham High-definition Transcranial Direct Current StimulationAlso: Sham HD-tDCSParticipants received sham stimulation using the same electrode positioning as the active conditions (International 10-20 System), with a central electrode over the left diaphragm cortex and four return electrodes. The device initially reached a current of 3 mA and then dropped to 0.1 mA within the first 30 seconds, remaining at this current for 20 minutes. A current of 3 mA was reinstated only in the final 30 seconds, accompanied by ramp-up and ramp-down phases, replicating the initial and final sensations of active stimulation without delivering a sustained therapeutic current. | Other | sham stimulation |
Primary outcome
Change in cerebral hemodynamic response
Time frame: Before, during, and after each 20-minute HD-tDCS session
Change in oxygenated (OxyHb) and deoxygenated (DeoxyHb) hemoglobin concentration measured by functional near-infrared spectroscopy (fNIRS)
1 secondary outcome
respiratory muscle strength
Time frame: Immediately before and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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. This study is not recruiting at the moment.
Suellen Andrade, PhD principal investigator
Federal University of Paraíba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-definition Transcranial Direct Current Stimulation in people with Chronic Obstructive Pulmonary Disease, run by Federal University of Paraíba at 1 site in Brazil.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral hemodynamic response (time frame: Before, during, and after each 20-minute HD-tDCS session). 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 21 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.