Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07332169
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
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.
Study:
NCT07332169
Study Brief:
Protocol Section:
NCT07332169