The Efficacy of Non-invasive Brain Stimulation on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease: Double-Blinded Randomised Controlled Trial
NCT ID: NCT07332169
Last Updated: 2026-01-12
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
24 participants
INTERVENTIONAL
2026-01-20
2028-11-30
Brief Summary
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* 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.
Participants will:
Receive NIBS or a sham-NIBS 5 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
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Detailed Description
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* 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:
* Both the participants and the outcome assessor will be in a double-blind RCT.
* King Fahad University Hospital will be the source of the entirely voluntary participants.
* The 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 four groups based on GOLD: mild GOLD 1, moderate GOLD 2, severe GOLD 3, and very severe GOLD 4.
* 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.
* Both groups will undergo the evaluation before and after the treatment sessions.
* Primary outcome measurements are battery cognition tests; secondary measures include ABGs, ultrasonography, 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Non-invasive brain stimulation
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.
Non-invasive brain stimulation
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 stimulation
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.
Sham Non-Invasive brain stimulation
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.
Interventions
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Non-invasive brain stimulation
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 stimulation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with confirmed COPD via pulmonary function test (PFT) according to the classifications of GOLD.
* All stages of GOLD 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 MoCA test.
* All MoCA stages will be included.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Imam Abdulrahman Bin Faisal University
OTHER
Shahad Abdulrahman Alkandari
OTHER_GOV
Responsible Party
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Shahad Abdulrahman Alkandari
Shahad Alkandari MSc, PT.
Locations
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Imam Abdulrahman Bin Faisal University
Dammam, , Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB-PGS-2025-03-0553
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-PGS-2025-03-0600
Identifier Type: -
Identifier Source: org_study_id
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