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:
Shahad Abdulrahman Alkandari
Organization:
Study Overview
Official Title:
The Efficacy of Non-invasive Brain Stimulation on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease: Double-Blinded Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIBS COPD
Brief 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. 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.
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
* 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
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:
* 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRB-PGS-2025-03-0553 | OTHER | Imam Abdulrahman Bin Faisal University | View |