COPDNIBS COPDNCT07332169
The Efficacy of Non-invasive Brain Stimulation (NIBS) on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Non-invasive brain stimulation in people with COPD and COPD (Chronic Obstructive Pulmonary Disease), run by Ministry of Health, Kuwait at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COPD, COPD (Chronic Obstructive Pulmonary Disease), Cognitive Impairment (CI)
- What is being tested?
- Non-invasive brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Jan 2026to 30 Nov 2028
- Phase
- Interventional
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult age from 18 years old to 70 years old.
- Patients with confirmed chronic obstructive pulmonary disease (COPD) via pulmonologist
- All stages of COPD severity will be included
- Stable patients, which means they were not admitted to the hospital in the last 3 months
- Patients with COPD with confirmed cognitive impairment by Montreal Cognitive Assessment (MoCA) test.
- All MoCA stages will be included.
Who cannot join
- Patients without COPD
- Unstable patients with several admission in the last 3 months
- Patients with COPD but without cognitive impairment.
- COPD patients who suffered from any neurological problems
- COPD patients who are contraindicated for using brain stimulation like psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Non-invasive Brain Stimulation on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease: Single-Blinded Randomised Controlled Trial
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:
- What is the possibility effect of using the NIBS on cognitive functions as well as the cardiopulmonary parameters in COPD population?
- 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.
Read more
Participants will:
Receive NIBS or a sham-NIBS 3 sessions/week for 3 weeks for 20 min each session.
Visit the clinic at the beginning for baseline assessment then after the completion of the 3 weeks to reassess them.
Outcome measures for cognitive parameters and pulmonary parameters will be taken pre and post NIBS intervention
Read the detailed description
- 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.
- Due to anomalies in the lung architecture, COPD is characterised by a variety of respiratory symptoms.
- Cognitive impairment (CI) is one of the problems caused by COPD that extends beyond the respiratory system.
- The quality of life, treatment compliance, and declines in the condition of COPD patients were all negatively impacted by CI.
- As of right now, no intervention has been promised to improve CI in patients with COPD.
Objective:
To find out how well non-invasive brain stimulation (NIBS), a novel technique, affects cognitive performance in COPD patients
Methods:
- The participants and one outcome assessor will be blinded.
- King Fahad University Hospital will be the source of the entirely voluntary participants.
- The Institutional Review Board (IRB) of the Imam Abdulrahman bin Faisal institutions accepted the study protocol.
- Following an evaluation using the Montreal Cognitive Assessment Test (MoCA), participants will be divided into 2 groups (experimental and control)
- For three weeks, both groups will participate in three NIBS sessions per week. While the control group will receive sham brain stimulation, the experimental group will receive active brain stimulation.
- Both groups will undergo the evaluation before and after the treatment sessions.
- Primary outcome measurements are battery cognition tests; secondary measures include transcranial doppler ultrasound and cardiopulmonary exercise tests.
- Independent t-tests will be applied to evaluate the differences between the two groups.
- The study will use a two-way repeated measures Analysis of Variance (ANOVA) to determine the intervention's efficacy.
- The association between the improvement of cognitive function and certain factors will be ascertained via the Pearson correlation coefficient.
- The significance level will be set at a p-value of less than 0.05.
Significant:
- 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.
- The findings of this study will investigate whether NIBS, which is beneficial in another population, can enhance cognitive function in individuals with COPD.
- Conditions
- COPD, COPD (Chronic Obstructive Pulmonary Disease), Cognitive Impairment (CI), Non-invasive Brain Stimulation
- Being tested
- Non-invasive brain stimulation, Sham Non-Invasive brain stimulation
- Keywords
- COPD, NIBS, non-invasive brain stimulation, cognitive function, cognitive impairment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brain stimulationDevice
Also called NIBS
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.
Sham Non-Invasive brain stimulationDevice
Also called NIBS
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive brain stimulation | Experimental | 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 3 session/week, for 3 weeks. Receives: Device: Non-invasive brain stimulation |
| Sham Non-invasive brain stimulation | Sham comparator | 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 3 session/week, for 3weeks. Receives: Device: Sham Non-Invasive brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The battery of neurocognitive tests
- 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.
Measured: At enrolment as baseline assessment and at the end of treatment at 3 weeks
Secondary outcomes (2)
Cardiopulmonary exercise test (CPET)
- 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.
Measured: At enrolment as baseline assessment and at the end of treatment at 3 weeks
Transcranial Doppler (TCD) ultrasound
- 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.
Measured: At enrolment as baseline assessment and at the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start20 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Model description
- Two groups included: One group will receive the non-invasive brain stimulation, and the other group will receive sham non-invasive brain stimulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Kuwait
- Sponsor type
- Other government
- Collaborators
- Imam Abdulrahman Bin Faisal University
- Responsible party
- Principal investigator, Shahad Abdulrahman Alkandari, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332169
- Sponsor's protocol ID
- IRB-PGS-2025-03-0600
- Other IDs
- IRB-PGS-2025-03-0553
- Acronym
- NIBS COPD
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26652115Lefaucheur 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.
PubMed 27866120Antal 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.
PubMed 28709880Manippa 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. Neuropsychol Rev. 2024 Mar;34(1):338-361. doi: 10.1007/s11065-023-09589-0. Epub 2023 Mar 6.
PubMed 36877327Chaieb L, Antal A, Pisoni A, Saiote C, Opitz A, Ambrus GG, Focke N, Paulus W. Safety of 5 kHz tACS. Brain Stimul. 2014 Jan-Feb;7(1):92-6. doi: 10.1016/j.brs.2013.08.004. Epub 2013 Sep 13.
PubMed 24064065Bikson M, Datta A, Elwassif M. Establishing safety limits for transcranial direct current stimulation. Clin Neurophysiol. 2009 Jun;120(6):1033-4. doi: 10.1016/j.clinph.2009.03.018. Epub 2009 Apr 24. No abstract available.
PubMed 19394269Zhou D, Li A, Li X, Zhuang W, Liang Y, Zheng CY, Zheng H, Yuan TF. Effects of 40 Hz transcranial alternating current stimulation (tACS) on cognitive functions of patients with Alzheimer's disease: a randomised, double-blind, sham-controlled clinical trial. J Neurol Neurosurg Psychiatry. 2022 May;93(5):568-570. doi: 10.1136/jnnp-2021-326885. Epub 2021 Nov 11. No abstract available.
PubMed 34764150Antal A, Herrmann CS. Transcranial Alternating Current and Random Noise Stimulation: Possible Mechanisms. Neural Plast. 2016;2016:3616807. doi: 10.1155/2016/3616807. Epub 2016 May 3.
PubMed 27242932Guerra A, Suppa A, Bologna M, D'Onofrio V, Bianchini E, Brown P, Di Lazzaro V, Berardelli A. Boosting the LTP-like plasticity effect of intermittent theta-burst stimulation using gamma transcranial alternating current stimulation. Brain Stimul. 2018 Jul-Aug;11(4):734-742. doi: 10.1016/j.brs.2018.03.015. Epub 2018 Mar 24.
PubMed 29615367Antal A, Boros K, Poreisz C, Chaieb L, Terney D, Paulus W. Comparatively weak after-effects of transcranial alternating current stimulation (tACS) on cortical excitability in humans. Brain Stimul. 2008 Apr;1(2):97-105. doi: 10.1016/j.brs.2007.10.001. Epub 2007 Dec 3.
PubMed 20633376GOLD. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease 2023 REPOR. 2023.
Tahasildar KK, Shrawasti SJ, Shete JS. Study of Arterial Blood Gas Analysis (ABG) in Patients of Obstructive Airway Diseases in Accordance with Clinical Correlation. Res J Med Sci. 2024;18:341-5.
Dash M, Apsara N, Chitra A. ABG Analysis and its Interpretation. Acta Scientific Paediatrics. 2019;2(10):108-11.
Bonow RH, Young CC, Bass DI, Moore A, Levitt MR. Transcranial Doppler ultrasonography in neurological surgery and neurocritical care. Neurosurg Focus. 2019 Dec 1;47(6):E2. doi: 10.3171/2019.9.FOCUS19611.
PubMed 31786564Purkayastha S, Sorond F. Transcranial Doppler ultrasound: technique and application. Semin Neurol. 2012 Sep;32(4):411-20. doi: 10.1055/s-0032-1331812. Epub 2013 Jan 29.
PubMed 23361485