Non-invasive Neustimulation and Respiratory Rehabilitation
NCT ID: NCT05886647
Last Updated: 2023-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-01-23
2024-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease
NCT04387318
More Air - Better Performance - Faster Recovery
NCT04686019
High-Intensity Respiratory Muscle Training in Individuals with Parkinson's Disease
NCT05608941
Respiratory Muscle Training in Subacute Stroke Patients
NCT02125760
Inspiratory Muscle Training Effectiveness in Sympathetic Activity and Functional Capacity in Patients With Heart Failure
NCT02600000
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 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.
Active non-invasive stimulation and inspiratory muscle training
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.
Group 2 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.
Sham compatorator and inspiratory muscle training
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active non-invasive stimulation and inspiratory muscle training
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 training
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* stable disease
Exclusion Criteria
* join another rehabilitation program
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Suellen Andrade
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Suellen Andrade
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Federal University of Paraiba
João Pessoa, Paraíba, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Azabou 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.
Bassi 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.
Brunoni 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.
Camargo 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.
Chan 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.
Dias 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.
Dmochowski 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.
Edwards 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.
Filipas 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.
Laviolette 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.
Morya 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.
Nakayama 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.
Nitsche 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.
Pereira 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.
Pilloni G, Bikson M, Badran BW, George MS, Kautz SA, Okano AH, Baptista AF, Charvet LE. Update on the Use of Transcranial Electrical Brain Stimulation to Manage Acute and Chronic COVID-19 Symptoms. Front Hum Neurosci. 2020 Nov 12;14:595567. doi: 10.3389/fnhum.2020.595567. eCollection 2020.
Polkey MI, Moxham J. Attacking the disease spiral in chronic obstructive pulmonary disease. Clin Med (Lond). 2006 Mar-Apr;6(2):190-6. doi: 10.7861/clinmedicine.6-2-190.
Singer J, Yelin EH, Katz PP, Sanchez G, Iribarren C, Eisner MD, Blanc PD. Respiratory and skeletal muscle strength in chronic obstructive pulmonary disease: impact on exercise capacity and lower extremity function. J Cardiopulm Rehabil Prev. 2011 Mar-Apr;31(2):111-9. doi: 10.1097/HCR.0b013e3182033663.
Shields GS, Coissi GS, Jimenez-Royo P, Gambarota G, Dimber R, Hopkinson NS, Matthews PM, Brown AP, Polkey MI. Bioenergetics and intermuscular fat in chronic obstructive pulmonary disease-associated quadriceps weakness. Muscle Nerve. 2015 Feb;51(2):214-21. doi: 10.1002/mus.24289. Epub 2014 Nov 19.
Silva CMDSE, Gomes Neto M, Saquetto MB, Conceicao CSD, Souza-Machado A. Effects of upper limb resistance exercise on aerobic capacity, muscle strength, and quality of life in COPD patients: a randomized controlled trial. Clin Rehabil. 2018 Dec;32(12):1636-1644. doi: 10.1177/0269215518787338. Epub 2018 Jul 16.
Souza DUF, Monteiro DP, Pinto RZ, Pereira DAG. Supervised Exercise Therapy for Intermittent Claudication. Phys Ther. 2020 Jan 23;100(1):8-13. doi: 10.1093/ptj/pzz140.
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.
Foster C, Florhaug JA, Franklin J, Gottschall L, Hrovatin LA, Parker S, Doleshal P, Dodge C. A new approach to monitoring exercise training. J Strength Cond Res. 2001 Feb;15(1):109-15.
Barreiro E, Gea J. Respiratory and Limb Muscle Dysfunction in COPD. COPD. 2015 Aug;12(4):413-26. doi: 10.3109/15412555.2014.974737.
Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HD-tDCS+respiratory disorders
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.