Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:10 AM
Study NCT ID:
NCT07332169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Non-invasive Brain Stimulation on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease: Double-Blinded Randomised Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-25', 'size': 363769, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-07T03:55', 'hasProtocol': True}, {'date': '2025-07-25', 'size': 539257, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-10-03T08:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups included: One group will receive the non-invasive brain stimulation, and the other group will receive sham non-invasive brain stimulation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-28', 'studyFirstSubmitDate': '2025-12-28', 'studyFirstSubmitQcDate': '2025-12-28', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Montreal Cognitive Assessment (MoCA) Test', 'timeFrame': 'Stratification outcome measure only at the beginning of the study', 'description': "\\* MoCA was employed as a stratification result measure at the start of the enrolment process. \\* MoCA is used to examine various cognitive areas to detect participants' cognitive impairment (CI). \\* MoCA test scores range from zero to 30, with a score of more than 26 considered CI. \\* The previously trained researcher will administer the test."}], 'primaryOutcomes': [{'measure': 'The battery of neurocognitive tests', 'timeFrame': 'At enrolment as baseline assessment and at the end of treatment at 3 weeks', 'description': '• Neuropsychological tests are going to be utilised to evaluate cognitive function. • The two key domains to be evaluated are memory and attention. • The Flanker Task will test the attention domain by examining how well the executive control network can be modulated by focusing on one stimulus while concurrently preventing the detection of another stimulus. • The Memory Automaticity Task will be used to evaluate working memory, requiring participants to complete Sternberg-style memory searches in order to attain automaticity; Recalling the existence of a specific letter in the memory set and accurately classifying it are prerequisites for this task. - The previously trained researcher will administer the test.'}], 'secondaryOutcomes': [{'measure': 'Cardiopulmonary exercise test (CPET)', 'timeFrame': 'At enrolment as baseline assessment and at the end of treatment at 3 weeks', 'description': "• The gold standard exercise test for calculating VO2 max is the cardiopulmonary exercise (CPET). • It will be used to evaluate COPD patients' functional capacity and VO2max. Each subject will be assessed using incremental CPET at maximal effort. • The modified Bruce procedure will be used to conduct the test on a treadmill. • Breath-by-breath analysis will be used to evaluate the following gas-exchange and ventilation measurements: VO2, end-tidal pressures for carbon dioxide and oxygen (PETCO2 and PETO2), ventilatory equivalents for carbon dioxide (VE/VCO2), and minute ventilation (VE). - The previously trained researcher will administer the test."}, {'measure': 'Transcranial Doppler (TCD) ultrasound', 'timeFrame': 'At enrolment as baseline assessment and at the end of treatment at 3 weeks', 'description': "\\- Transcranial Doppler (TCD) ultrasound allows for the real-time monitoring of cerebrovascular haemodynamic and blood flow parameters throughout the brain's basal arteries. - Taking into account both the end-diastolic and peak systolic flow velocities, the mean flow velocity (MFV) is calculated, and a few important intracranial arteries are evaluated using the temporal bone window. - Qualified neurologists and vascular technologists will conduct the exam."}, {'measure': 'Arterial blood gas analysis (ABGs)', 'timeFrame': 'At enrolment as baseline assessment and at the end of treatment at 3 weeks', 'description': "• The acid-base balance and arterial blood oxygenation are measured by arterial blood gas analysis (ABGs), which uses blood drawn from an artery. • We shall test the arterial carbon dioxide tension (PCO2), arterial blood gas oxygen tension (PO2), and pH. • Patients requiring oxygen will be assessed while using their typical inspiratory oxygen fraction. \\* The test will be done as part of a hospital's routine."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'NIBS', 'non-invasive brain stimulation', 'cognitive function', 'cognitive impairment'], 'conditions': ['COPD', 'COPD (Chronic Obstructive Pulmonary Disease)', 'Cognitive Impairment (CI)', 'Non-invasive Brain Stimulation']}, 'referencesModule': {'references': [{'pmid': '26652115', 'type': 'BACKGROUND', 'citation': 'Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22.'}, {'pmid': '27866120', 'type': 'BACKGROUND', 'citation': 'Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.'}, {'pmid': '28709880', 'type': 'BACKGROUND', 'citation': 'Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.'}, {'pmid': '36877327', 'type': 'BACKGROUND', 'citation': 'Manippa V, Palmisano A, Nitsche MA, Filardi M, Vilella D, Logroscino G, Rivolta D. Cognitive and Neuropathophysiological Outcomes of Gamma-tACS in Dementia: A Systematic Review. 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Alzheimers Res Ther. 2015 Mar 21;7(1):32. doi: 10.1186/s13195-015-0116-3. eCollection 2015.'}, {'pmid': '30336140', 'type': 'BACKGROUND', 'citation': 'Pelgrim CE, Peterson JD, Gosker HR, Schols AMWJ, van Helvoort A, Garssen J, Folkerts G, Kraneveld AD. Psychological co-morbidities in COPD: Targeting systemic inflammation, a benefit for both? Eur J Pharmacol. 2019 Jan 5;842:99-110. doi: 10.1016/j.ejphar.2018.10.001. Epub 2018 Oct 15.'}, {'pmid': '28292570', 'type': 'BACKGROUND', 'citation': 'Yohannes AM, Chen W, Moga AM, Leroi I, Connolly MJ. Cognitive Impairment in Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: A Systematic Review and Meta-analysis of Observational Studies. J Am Med Dir Assoc. 2017 May 1;18(5):451.e1-451.e11. doi: 10.1016/j.jamda.2017.01.014. Epub 2017 Mar 11.'}, {'pmid': '27393566', 'type': 'BACKGROUND', 'citation': 'Lindbergh CA, Dishman RK, Miller LS. Functional Disability in Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2016 Jun;26(2):129-59. doi: 10.1007/s11065-016-9321-5. Epub 2016 Jul 8.'}, {'pmid': '25909154', 'type': 'BACKGROUND', 'citation': 'Torres-Sanchez I, Rodriguez-Alzueta E, Cabrera-Martos I, Lopez-Torres I, Moreno-Ramirez MP, Valenza MC. Cognitive impairment in COPD: a systematic review. J Bras Pneumol. 2015 Mar-Apr;41(2):182-90. doi: 10.1590/S1806-37132015000004424. Epub 2015 Apr 18.'}, {'type': 'BACKGROUND', 'citation': 'Dhakal A, Bobrin BD. Cognitive Deficits. StatPearls. Treasure Island (FL) ineligible companies. Disclosure: Bradford Bobrin declares no relevant financial relationships with ineligible companies.: StatPearls Publishing Copyright © 2023, StatPearls Publishing LLC.; 2023.'}, {'pmid': '20356988', 'type': 'BACKGROUND', 'citation': 'Dodd JW, Getov SV, Jones PW. Cognitive function in COPD. Eur Respir J. 2010 Apr;35(4):913-22. doi: 10.1183/09031936.00125109.'}, {'pmid': '32184750', 'type': 'BACKGROUND', 'citation': 'Ranzini L, Schiavi M, Pierobon A, Granata N, Giardini A. From Mild Cognitive Impairment (MCI) to Dementia in Chronic Obstructive Pulmonary Disease. Implications for Clinical Practice and Disease Management: A Mini-Review. Front Psychol. 2020 Feb 28;11:337. doi: 10.3389/fpsyg.2020.00337. eCollection 2020.'}, {'pmid': '28638422', 'type': 'BACKGROUND', 'citation': 'Samareh Fekri M, Hashemi-Bajgani SM, Naghibzadeh-Tahami A, Arabnejad F. Cognitive Impairment among Patients with Chronic Obstructive Pulmonary Disease Compared to Normal Individuals. Tanaffos. 2017;16(1):34-39.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine if non-invasive brain stimulation (NIBS) can enhance cognitive function with chronic obstructive pulmonary disease (COPD) population. The main questions it aims to answer are:\n\n* What is the possibility effect of using the NIBS on cognitive functions as well as the cardiopulmonary parameters in COPD population?\n* What is the relation between cognitive function parameters and cardiopulmonary parameters in COPD population who suffer from cognitive impairment (CI)? Researchers will compare NIBS to a sham-NIBS to see if NIBS works to improve cognitive function in COPD population.\n\nParticipants will:\n\nReceive NIBS or a sham-NIBS 5 sessions/week for 3 weeks for 20 min each session.\n\nVisit the clinic at the beginning for baseline assessment then after the completion of the 3 weeks to reassess them.\n\nOutcome measures for cognitive parameters and pulmonary parameters will be taken pre and post NIBS intervention', 'detailedDescription': "* With over 3.2 million fatalities worldwide, chronic obstructive pulmonary disease (COPD) is considered the third most common cause of mortality and a potentially fatal illness.\n* Due to anomalies in the lung architecture, COPD is characterised by a variety of respiratory symptoms.\n* Cognitive impairment (CI) is one of the problems caused by COPD that extends beyond the respiratory system.\n* The quality of life, treatment compliance, and declines in the condition of COPD patients were all negatively impacted by CI.\n* As of right now, no intervention has been promised to improve CI in patients with COPD.\n\nObjective:\n\nTo find out how well non-invasive brain stimulation (NIBS), a novel technique, affects cognitive performance in COPD patients\n\nMethods:\n\n* Both the participants and the outcome assessor will be in a double-blind RCT.\n* King Fahad University Hospital will be the source of the entirely voluntary participants.\n* The IRB of the Imam Abdulrahman bin Faisal institutions accepted the study protocol.\n* Following an evaluation using the Montreal Cognitive Assessment Test (MoCA), participants will be divided into four groups based on GOLD: mild GOLD 1, moderate GOLD 2, severe GOLD 3, and very severe GOLD 4.\n* For three weeks, both groups will participate in five NIBS sessions per week. While the control group will receive sham brain stimulation, the experimental group will receive active brain stimulation.\n* Both groups will undergo the evaluation before and after the treatment sessions.\n* Primary outcome measurements are battery cognition tests; secondary measures include ABGs, ultrasonography, and cardiopulmonary exercise tests.\n* Independent t-tests will be applied to evaluate the differences between the two groups.\n* The study will use a two-way repeated measures Analysis of Variance (ANOVA) to determine the intervention's efficacy.\n* The association between the improvement of cognitive function and certain factors will be ascertained via the Pearson correlation coefficient.\n* The significance level will be set at a p-value of less than 0.05.\n\nSignificant:\n\n* We hope that the findings of this study will serve as a helpful guide when deciding how to improve CI in patients with COPD and enhance the treatment strategy for this group.\n* The findings of this study will investigate whether NIBS, which is beneficial in another population, can enhance cognitive function in individuals with COPD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult age from eighteen years old and above.\n* Patients with confirmed COPD via pulmonary function test (PFT) according to the classifications of GOLD.\n* All stages of GOLD will be included\n* Stable patients, which means they were not admitted to the hospital in the last 3 months\n* Patients with COPD with confirmed cognitive impairment by MoCA test.\n* All MoCA stages will be included.\n\nExclusion Criteria:\n\n* Patients without COPD\n* Unstable patients with several admission in the last 3 months\n* Patients with COPD but without cognitive impairment.\n* COPD patients who suffered from any neurological problems\n* COPD patients who are contraindicated for using brain stimulation like psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT07332169', 'acronym': 'NIBS COPD', 'briefTitle': 'The Efficacy of Non-invasive Brain Stimulation on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease: Double-Blinded Randomised Controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Kuwait'}, 'officialTitle': 'The Efficacy of Non-invasive Brain Stimulation on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease: Double-Blinded Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB-PGS-2025-03-0600'}, 'secondaryIdInfos': [{'id': 'IRB-PGS-2025-03-0553', 'type': 'OTHER', 'domain': 'Imam Abdulrahman Bin Faisal University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-invasive brain stimulation', 'description': 'Sinusoidal current used between two electrodes on the dorsolateral prefrontal cortex (DLPFC) area. - Gamma-Transcranial Alternating Current Stimulation (tACS) of 2 mA at 40 Hz will be given to the experimental group. - Session duration will last 20 minutes, of 5 session/week, for 3weeks.', 'interventionNames': ['Device: Non-invasive brain stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Non-invasive brain stimulation', 'description': "Sinusoidal current used between two electrodes on the dorsolateral prefrontal cortex (DLPFC) area. - To maintain this stimulation's indistinguishability from the experimental stimulation, the control group will be given an electric current that ramps down 60 seconds after the stimulation begins. - Session duration will last 20 minutes, of 5 session/week, for 3weeks.", 'interventionNames': ['Device: Sham Non-Invasive brain stimulation']}], 'interventions': [{'name': 'Non-invasive brain stimulation', 'type': 'DEVICE', 'otherNames': ['NIBS'], 'description': 'Non-invasive brain stimulation (NIBS) modifies brain activity without surgery using electric currents. - Transcranial alternating current stimulation (tACS) is one type of NIBS that modifies neuronal oscillations in the brain by applying alternating electrical currents to the scalp through electrodes. - This method can enhance motor abilities, improve cognitive functions, and be used in rehabilitation. - It does this by entraining neurones, which synchronise their firing to the applied sinusoidal frequency. Gamma-Transcranial Alternating Current Stimulation (tACS) of 2 mA at 40 Hz will be given to the experimental group.', 'armGroupLabels': ['Non-invasive brain stimulation']}, {'name': 'Sham Non-Invasive brain stimulation', 'type': 'DEVICE', 'otherNames': ['NIBS'], 'description': 'Non-invasive brain stimulation (NIBS) modifies brain activity without surgery using electric currents. - Transcranial alternating current stimulation (tACS) is one type of NIBS that modifies neuronal oscillations in the brain by applying alternating electrical currents to the scalp through electrodes. - This method can enhance motor abilities, improve cognitive functions, and be used in rehabilitation. - It does this by entraining neurones, which synchronise their firing to the applied sinusoidal frequency. The electric current used as ramps down 60 seconds after the stimulation begins.', 'armGroupLabels': ['Sham Non-invasive brain stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dammam', 'country': 'Saudi Arabia', 'contacts': [{'name': "Shahad Alkandari, Master's degree", 'role': 'CONTACT', 'email': 'alkandari-shahad@hotmail.com', 'phone': '+96597533309'}], 'facility': 'Imam Abdulrahman Bin Faisal University', 'geoPoint': {'lat': 26.43442, 'lon': 50.10326}}], 'centralContacts': [{'name': "Shahad Alkandari, Master's degree", 'role': 'CONTACT', 'email': 'alkandari-shahad@hotmail.com', 'phone': '+96597533309'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahad Abdulrahman Alkandari', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Imam Abdulrahman Bin Faisal University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Shahad Alkandari MSc, PT.', 'investigatorFullName': 'Shahad Abdulrahman Alkandari', 'investigatorAffiliation': 'Ministry of Health, Kuwait'}}}}