NCT07332169

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shahad Abdulrahman Alkandari · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• COPD (Chronic Obstructive Pulmonary Disease)
• Cognitive Impairment (CI)
• Non-invasive Brain Stimulation

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2026-01-20
• Primary completion: 2028-01-01
• Completion: 2028-11-30
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: Saudi Arabia