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
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 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
Parallel
Non-invasive brain stimulation
DeviceNon-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
DeviceNon-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.
The battery of neurocognitive tests
• Neuropsychological tests are going to be utilised to evaluate cognitive function. • The two key domains to be evaluated are memory and attention. • The Flanker Task will test the attention domain by examining how well the executive control network can be modulated by focusing on one stimulus while concurrently preventing the detection of another stimulus. • The Memory Automaticity Task will be used to evaluate working memory, requiring participants to complete Sternberg-style memory searches in order to attain automaticity; Recalling the existence of a specific letter in the memory set and accurately classifying it are prerequisites for this task. - The previously trained researcher will administer the test.
Cardiopulmonary exercise test (CPET)
• The gold standard exercise test for calculating VO2 max is the cardiopulmonary exercise (CPET). • It will be used to evaluate COPD patients' functional capacity and VO2max. Each subject will be assessed using incremental CPET at maximal effort. • The modified Bruce procedure will be used to conduct the test on a treadmill. • Breath-by-breath analysis will be used to evaluate the following gas-exchange and ventilation measurements: VO2, end-tidal pressures for carbon dioxide and oxygen (PETCO2 and PETO2), ventilatory equivalents for carbon dioxide (VE/VCO2), and minute ventilation (VE). - The previously trained researcher will administer the test.
Transcranial Doppler (TCD) ultrasound
\- Transcranial Doppler (TCD) ultrasound allows for the real-time monitoring of cerebrovascular haemodynamic and blood flow parameters throughout the brain's basal arteries. - Taking into account both the end-diastolic and peak systolic flow velocities, the mean flow velocity (MFV) is calculated, and a few important intracranial arteries are evaluated using the temporal bone window. - Qualified neurologists and vascular technologists will conduct the exam.
Arterial blood gas analysis (ABGs)
• The acid-base balance and arterial blood oxygenation are measured by arterial blood gas analysis (ABGs), which uses blood drawn from an artery. • We shall test the arterial carbon dioxide tension (PCO2), arterial blood gas oxygen tension (PO2), and pH. • Patients requiring oxygen will be assessed while using their typical inspiratory oxygen fraction. \* The test will be done as part of a hospital's routine.
Montreal Cognitive Assessment (MoCA) Test
\* MoCA was employed as a stratification result measure at the start of the enrolment process. \* MoCA is used to examine various cognitive areas to detect participants' cognitive impairment (CI). \* MoCA test scores range from zero to 30, with a score of more than 26 considered CI. \* The previously trained researcher will administer the test.
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Shahad Abdulrahman Alkandari
Lead sponsor
Ministry of Health, Kuwait
Sponsor institution
Imam Abdulrahman Bin Faisal University
Collaborator
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