Lung DiseasesNCT05886647
Non-invasive Neustimulation and Respiratory Rehabilitation
A study testing Active non-invasive stimulation and inspiratory muscle training in people with Lung Diseases, run by Suellen Andrade at 1 site in Brazil.
Trial summary
Introduction: Respiratory diseases are associated with high rate of morbidity and mortality in Brazil. Cardiopulmonary rehabilitation through respiratory muscle training, aerobic training and strengthening of upper and lower limbs emerges as one of the resources available for the treatment and monitoring of patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Active non-invasive stimulation and inspiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Jan 2023to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed clinical diagnosis for respiratory disease;
- stable disease
Who cannot join
- develop disabling condition that prevents the implementation of the protocol;
- join another rehabilitation program
Trial locations and contacts
1 site in 1 country.
Suellen M Marinho dos Santos Andrade, Doctor contact
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Paraiba
João Pessoa, Paraíba, 51051900
Suellen M Marinho dos Santos Andrade, Doctor, 83993812744 ext. +55, suellen.andrade@academico.ufpb.br
Eduardo ET de França, Doctor, 83996575859 ext. +55, eduardo.eriko@academico.ufpb.br
About this study
Official title: Non-invasive Neurostimulation and Rehabilitation in the Treatment of Patients With Respiratory Disorders: Randomized Controlled Clinical Trial
Introduction: Respiratory diseases are associated with high rate of morbidity and mortality in Brazil. Cardiopulmonary rehabilitation through respiratory muscle training, aerobic training and strengthening of upper and lower limbs emerges as one of the resources available for the treatment and monitoring of patients with respiratory diseases. To add in this perspective, the application of HD-tDCS induces significant neurophysiological and clinical effects in several body systems.
Objective: To identify the chronic effects of non-invasive neurostimulation associated with the rehabilitation of patients with respiratory disorders. Material and methods: This is a pilot study, quantitative, clinical trial type, randomized and controlled, double blind. The sample will be composed by patients with respiratory diseases, aged above 18 years old. The study will consist of two groups: (1) HD-tDCS will be applied - anodic current + respiratory rehabilitation with respiratory muscle training (RMT) and (2) Sham - Only respiratory rehabilitation with RMT without any type of cortical stimulation. The chronic effects of neurostimulation by HD-tDCS associated with cardiopulmonary rehabilitation, with TMR, during 12 sessions will be evaluated. Patients will be evaluated, before and after the protocol, in relation to cortical activation function, pulmonary function, subjective perception of effort, respiratory muscle function, functional capacity, sensation of dyspnea and quality of life. For statistical analysis, intention-to-treat analysis will be used and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary outcomes. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Neurostimulation would enhance the effects of respiratory rehabilitation and reduce the symptoms of patients with these diseases.
- Conditions
- Lung Diseases
- Being tested
- Active non-invasive stimulation and inspiratory muscle training, Sham compatorator and inspiratory muscle training
- Keywords
- Brain Stimulation, Performance, Exercise
- Medical subject headings
- Lung Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active non-invasive stimulation and inspiratory muscle trainingOther
Simultaneously with the current application, the patient will perform inspiratory muscle training (IMT) by KH2; PowerBreathe International Ltd. UK along with a feedback Breathelink, consisting of three series of two minutes of maximum and deep inspirations followed by two minutes of rest between them, totaling six minutes of TMI.
Sham compatorator and inspiratory muscle trainingOther
As for the patients allocated in the control group, they will receive the HD-tDCS sham for 20 minutes associated with IMT, following for the same training, duration and load increment used in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 experimental | Experimental | group composed by patients with respiratory disorders, which will undergo 12 sessions of neurostimulation by HD-tDCS 4x1 (tDCS 1x1, developed by Soterix Medical Inc.).
A current of 3 mA will be provided, positioning a central electrode (anode) on the left diaphragmatic primary motor cortex (4 cm lateral to the midline and 1 cm anterior to the binaural line) and the four return electrodes in a radius of 8 cm to the around. At the same time, inspiratory muscle training (IMT) will be performed by KH2; PowerBreathe International Ltd. UK with visual feedback, consisting of three series of two minutes of maximum and deep inspirations followed by two minutes of rest between them, totaling six minutes of TMI. The initial load will be through the maximum inspiratory pressure (MIP) achieved in the initial evaluation, using 40% of the total MIP in the first three weeks and 70% of the protocol will be used 40% of the MIP in the remaining three weeks and 70% in the remaining weeks. Receives: Other: Active non-invasive stimulation and inspiratory muscle training |
| Group 2 sham comparator | Sham comparator | The participants allocated in the control group will receive the sham HD tDCS for 20 minutes associated with the IMT, following for this training the same load guidelines, duration and load increment used in the experimental group. Receives: Other: Sham compatorator and inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Spirometry will be performed following the American Thoracic criteria Society (ATS). All participants will undergo a minimum of three maneuvers, in a sitting position, with a nose clip and mouthpiece attached. It will be instructed to perform maximum inspiration, up to total lung capacity, followed by a maximal and continuous forced expiration for at least six seconds, until residual volume.
Measured: six weeks
Secondary outcomes (5)
Maximum inspiratory pressure
To assess the maximum inspiratory pressure, a computerized electronic device (KH2; PowerBreathe International Ltd. United Kingdom) will be used. The participant will be seated, arms supported and nose clip to prevent air leaks.
The maneuver consists of exhaling to the residual volume and performing a maximum inspiration maintained for as long as possible, being repeated 3 to 8 times to have a variation of less than 10%, based on the highest value.
Measured: six weeks
functional capacity
Functional capacity will be assessed considering the distance covered in the six-minute walk test (6MWT). The 6MWT will be performed in a 30-meter corridor, checking heart rate (HR), peripheral oxygen saturation (SPO2), blood pressure (BP) and subjective perception of dyspnea by the Borg scale at the beginning and end of the test.
HR and SpO2 will be observed throughout the test. For this porpuse, it will be used a stopwatch, a pulse oximeter to measure HR and SpO2, a sphygmomanometer to measure BP, a printed Borg scale that will be shown to the patient, a chair that can be moved to any area of the track and two cones to mark the return points that will be placed at the beginning and end of the test track.
The test track will be marked in every 3 meters, in a closed environment and at a comfortable temperature.
Instructions will be given for the patient to walk as fast as possible without running, in addition to warnings regarding the elapsed time of the test.
Measured: six weeks
dyspnea sensation
For the evaluation of this outcome, it will be assessed by the dyspnea scale of the modified Medical Research Council (mMRC), which measures the degree of dyspnea in specific daily activities. The mMRC is divided into 4 grades, ranging from 0 (dyspnea on intense exercise) to 4 (dyspnea on minimal exertion) such as dressing or bathing). The scale is widely used in patients by its simplicity, easyness of use and correlation with quality of life, prognosis and distance covered in the six-minute walk test.
Measured: six weeks
health-related quality of life
The assessment of health-related quality of life will be carried out through the application of a generic quality of life assessment questionnaire, the SF 36, which is a self-assessment instrument used to assess the quality of life of adults and is organized in eight dimensions: functionality (10 items), limitation caused by the physical problem (4 items), body pain (2 items), general health perception (5 items), vitality (4 items), social function (2 items), limitation caused by the emotional problem (3 items), mental health (5 items). A score is obtained through an algorithm (from 0 to 100), where 0 = lowest quality of life and 100 = better quality of life.
Measured: six weeks
respiratory muscle resistance
To assess respiratory muscle resistance, a computerized electronic device (KH2; PowerBreathe International Ltd. United Kingdom) will be used. With the participant seated, arms supported and nose clip to prevent air leaks.
The test consists of applying an incremental load, where the maximum number of breaths is performed for two minutes, starting with a load of 10 cmH2O and increasing this same value at each cycle, with a minute of rest. The highest value sustained for at least one minute will be considered.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start23 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suellen Andrade
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suellen Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886647
- Sponsor's protocol ID
- HD-tDCS+respiratory disorders
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Azabou E, Bao G, Heming N, Bounab R, Moine P, Chevallier S, Chevret S, Resche-Rigon M, Siami S, Sharshar T, Lofaso F, Annane D. Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol. Front Med (Lausanne). 2020 Jun 26;7:372. doi: 10.3389/fmed.2020.00372. eCollection 2020.
PubMed 32671084Bassi TG, Rohrs EC, Fernandez KC, Ornowska M, Nicholas M, Gani M, Evans D, Reynolds SC. Transvenous Diaphragm Neurostimulation Mitigates Ventilation-associated Brain Injury. Am J Respir Crit Care Med. 2021 Dec 15;204(12):1391-1402. doi: 10.1164/rccm.202101-0076OC.
PubMed 34491883Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
PubMed 22037126Camargo LA, Pereira CA. Dyspnea in COPD: beyond the modified Medical Research Council scale. J Bras Pneumol. 2010 Sep-Oct;36(5):571-8. doi: 10.1590/s1806-37132010000500008. English, Portuguese.
PubMed 21085822Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PubMed 23295957Dias FD, Sampaio LM, da Silva GA, Gomes EL, do Nascimento ES, Alves VL, Stirbulov R, Costa D. Home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized clinical trial. Int J Chron Obstruct Pulmon Dis. 2013;8:537-44. doi: 10.2147/COPD.S50213. Epub 2013 Nov 5.
PubMed 24235824Dmochowski JP, Datta A, Bikson M, Su Y, Parra LC. Optimized multi-electrode stimulation increases focality and intensity at target. J Neural Eng. 2011 Aug;8(4):046011. doi: 10.1088/1741-2560/8/4/046011. Epub 2011 Jun 10.
PubMed 21659696Edwards D, Cortes M, Datta A, Minhas P, Wassermann EM, Bikson M. Physiological and modeling evidence for focal transcranial electrical brain stimulation in humans: a basis for high-definition tDCS. Neuroimage. 2013 Jul 1;74:266-75. doi: 10.1016/j.neuroimage.2013.01.042. Epub 2013 Jan 28.
PubMed 23370061Filipas L, Gallo G, Meloni A, Luzi L, Codella R. Effects of bilateral dorsolateral prefrontal cortex high-definition transcranial direct-current stimulation on time-trial performance in cyclists with type 1 diabetes mellitus. Brain Stimul. 2022 Sep-Oct;15(5):1292-1299. doi: 10.1016/j.brs.2022.09.005. Epub 2022 Sep 17.
PubMed 36126864Laviolette L, Nierat MC, Hudson AL, Raux M, Allard E, Similowski T. The supplementary motor area exerts a tonic excitatory influence on corticospinal projections to phrenic motoneurons in awake humans. PLoS One. 2013 Apr 16;8(4):e62258. doi: 10.1371/journal.pone.0062258. Print 2013.
PubMed 23614046Morya E, Monte-Silva K, Bikson M, Esmaeilpour Z, Biazoli CE Jr, Fonseca A, Bocci T, Farzan F, Chatterjee R, Hausdorff JM, da Silva Machado DG, Brunoni AR, Mezger E, Moscaleski LA, Pegado R, Sato JR, Caetano MS, Sa KN, Tanaka C, Li LM, Baptista AF, Okano AH. Beyond the target area: an integrative view of tDCS-induced motor cortex modulation in patients and athletes. J Neuroeng Rehabil. 2019 Nov 15;16(1):141. doi: 10.1186/s12984-019-0581-1.
PubMed 31730494Nakayama T, Fujii Y, Suzuki K, Kanazawa I, Nakada T. The primary motor area for voluntary diaphragmatic motion identified by high field fMRI. J Neurol. 2004 Jun;251(6):730-5. doi: 10.1007/s00415-004-0413-4.
PubMed 15311350Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
PubMed 10990547Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
PubMed 17982531
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Neurostimulation and Rehabilitation in the Treatment of Patients With Respiratory Disorders: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05886647
- Acronym / sponsor ID
- HD-tDCS+respiratory disorders
- Conditions
- Lung Diseases
- Keywords
- Brain Stimulation, Performance, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suellen AndradeUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 2 Jun 2023 (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.
Introduction: Respiratory diseases are associated with high rate of morbidity and mortality in Brazil. Cardiopulmonary rehabilitation through respiratory muscle training, aerobic training and strengthening of upper and lower limbs emerges as one of the resources available for the treatment and monitoring of patients with respiratory diseases. To add in this perspective, the application of HD-tDCS induces significant neurophysiological and clinical effects in several body systems.
Objective: To identify the chronic effects of non-invasive neurostimulation associated with the rehabilitation of patients with respiratory disorders. Material and methods: This is a pilot study, quantitative, clinical trial type, randomized and controlled, double blind. The sample will be composed by patients with respiratory diseases, aged above 18 years old. The study will consist of two groups: (1) HD-tDCS will be applied - anodic current + respiratory rehabilitation with respiratory muscle training (RMT) and (2) Sham - Only respiratory rehabilitation with RMT without any type of cortical stimulation. The chronic effects of neurostimulation by HD-tDCS associated with cardiopulmonary rehabilitation, with TMR, during 12 sessions will be evaluated. Patients will be evaluated, before and after the protocol, in relation to cortical activation function, pulmonary function, subjective perception of effort, respiratory muscle function, functional capacity, sensation of dyspnea and quality of life. For statistical analysis, intention-to-treat analysis will be used and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary outcomes. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Neurostimulation would enhance the effects of respiratory rehabilitation and reduce the symptoms of patients with these diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 experimental | Experimental | Other: Active non-invasive stimulation and inspiratory muscle traininggroup composed by patients with respiratory disorders, which will undergo 12 sessions of neurostimulation by HD-tDCS 4x1 (tDCS 1x1, developed by Soterix Medical Inc.). A current of 3 mA will be provided, positioning a central electrode (anode) on the left diaphragmatic primary motor cortex (4 cm lateral to the midline and 1 cm anterior to the binaural line) and the four return electrodes in a radius of 8 cm to the around. At the same time, inspiratory muscle training (IMT) will be performed by KH2; PowerBreathe International Ltd. UK with visual feedback, consisting of three series of two minutes of maximum and deep inspirations followed by two minutes of rest between them, totaling six minutes of TMI. The initial load will be through the maximum inspiratory pressure (MIP) achieved in the initial evaluation, using 40% of the total MIP in the first three weeks and 70% of the protocol will be used 40% of the MIP in the remaining three weeks and 70% in the remaining weeks. |
| Group 2 sham comparator | Sham comparator | Other: Sham compatorator and inspiratory muscle trainingThe participants allocated in the control group will receive the sham HD tDCS for 20 minutes associated with the IMT, following for this training the same load guidelines, duration and load increment used in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- confirmed clinical diagnosis for respiratory disease;
- stable disease
Key exclusion criteria (2 listed)
- develop disabling condition that prevents the implementation of the protocol;
- join another rehabilitation program
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 non-invasive stimulation and inspiratory muscle trainingSimultaneously with the current application, the patient will perform inspiratory muscle training (IMT) by KH2; PowerBreathe International Ltd. UK along with a feedback Breathelink, consisting of three series of two minutes of maximum and deep inspirations followed by two minutes of rest between them, totaling six minutes of TMI. | Other | Group 1 experimental |
| Sham compatorator and inspiratory muscle trainingAs for the patients allocated in the control group, they will receive the HD-tDCS sham for 20 minutes associated with IMT, following for the same training, duration and load increment used in the experimental group. | Other | Group 2 sham comparator |
Primary outcome
Lung function
Time frame: six weeks
Spirometry will be performed following the American Thoracic criteria Society (ATS). All participants will undergo a minimum of three maneuvers, in a sitting position, with a nose clip and mouthpiece attached. It will be instructed to perform maximum inspiration, up to total lung capacity, followed by a maximal and continuous forced expiration for at least six seconds, until residual volume.
5 secondary outcomes
Maximum inspiratory pressure
Time frame: six weeks
functional capacity
Time frame: six weeks
dyspnea sensation
Time frame: six weeks
health-related quality of life
Time frame: six weeks
respiratory muscle resistance
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 32671084Azabou E, Bao G, Heming N, Bounab R, Moine P, Chevallier S, Chevret S, Resche-Rigon M, Siami S, Sharshar T, Lofaso F, Annane D. Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol. Front Med (Lausanne). 2020 Jun 26;7:372. doi: 10.3389/fmed.2020.00372. eCollection 2020.
- Background: PubMed 34491883Bassi TG, Rohrs EC, Fernandez KC, Ornowska M, Nicholas M, Gani M, Evans D, Reynolds SC. Transvenous Diaphragm Neurostimulation Mitigates Ventilation-associated Brain Injury. Am J Respir Crit Care Med. 2021 Dec 15;204(12):1391-1402. doi: 10.1164/rccm.202101-0076OC.
- Background: PubMed 22037126Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
- Background: PubMed 21085822Camargo LA, Pereira CA. Dyspnea in COPD: beyond the modified Medical Research Council scale. J Bras Pneumol. 2010 Sep-Oct;36(5):571-8. doi: 10.1590/s1806-37132010000500008. English, Portuguese.
- Background: PubMed 23295957Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
- Background: PubMed 24235824Dias FD, Sampaio LM, da Silva GA, Gomes EL, do Nascimento ES, Alves VL, Stirbulov R, Costa D. Home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized clinical trial. Int J Chron Obstruct Pulmon Dis. 2013;8:537-44. doi: 10.2147/COPD.S50213. Epub 2013 Nov 5.
- Background: PubMed 21659696Dmochowski JP, Datta A, Bikson M, Su Y, Parra LC. Optimized multi-electrode stimulation increases focality and intensity at target. J Neural Eng. 2011 Aug;8(4):046011. doi: 10.1088/1741-2560/8/4/046011. Epub 2011 Jun 10.
- Background: PubMed 23370061Edwards D, Cortes M, Datta A, Minhas P, Wassermann EM, Bikson M. Physiological and modeling evidence for focal transcranial electrical brain stimulation in humans: a basis for high-definition tDCS. Neuroimage. 2013 Jul 1;74:266-75. doi: 10.1016/j.neuroimage.2013.01.042. Epub 2013 Jan 28.
- Background: PubMed 36126864Filipas L, Gallo G, Meloni A, Luzi L, Codella R. Effects of bilateral dorsolateral prefrontal cortex high-definition transcranial direct-current stimulation on time-trial performance in cyclists with type 1 diabetes mellitus. Brain Stimul. 2022 Sep-Oct;15(5):1292-1299. doi: 10.1016/j.brs.2022.09.005. Epub 2022 Sep 17.
- Background: PubMed 23614046Laviolette L, Nierat MC, Hudson AL, Raux M, Allard E, Similowski T. The supplementary motor area exerts a tonic excitatory influence on corticospinal projections to phrenic motoneurons in awake humans. PLoS One. 2013 Apr 16;8(4):e62258. doi: 10.1371/journal.pone.0062258. Print 2013.
- Background: PubMed 31730494Morya E, Monte-Silva K, Bikson M, Esmaeilpour Z, Biazoli CE Jr, Fonseca A, Bocci T, Farzan F, Chatterjee R, Hausdorff JM, da Silva Machado DG, Brunoni AR, Mezger E, Moscaleski LA, Pegado R, Sato JR, Caetano MS, Sa KN, Tanaka C, Li LM, Baptista AF, Okano AH. Beyond the target area: an integrative view of tDCS-induced motor cortex modulation in patients and athletes. J Neuroeng Rehabil. 2019 Nov 15;16(1):141. doi: 10.1186/s12984-019-0581-1.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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 M Marinho dos Santos Andrade, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active non-invasive stimulation and inspiratory muscle training in people with Lung Diseases, run by Suellen Andrade 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suellen M Marinho dos Santos Andrade, Doctor (83 9 93812744 ext. +55, suellen.andrade@academico.ufpb.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05886647, which also lists 27 linked publications.
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 2 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.