The Efficacy of Non-invasive Brain Stimulation on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease: Double-Blinded Randomised Controlled Trial (NIBS COPD)

Shahad Abdulrahman Alkandari

Status: Not yet enrolling

Conditions: Non-invasive Brain Stimulation; COPD (Chronic Obstructive Pulmonary Disease); Cognitive Impairment (CI); COPD

Treatments: Device: Non-invasive brain stimulation; Device: Sham Non-Invasive brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07332169

IRB-PGS-2025-03-0600

IRB-PGS-2025-03-0553 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult age from eighteen years old and above.
• 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

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Non-invasive brain stimulation

Experimental group

Description:

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.

Treatment:

Device: Non-invasive brain stimulation

Sham Non-invasive brain stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Non-Invasive brain stimulation