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Starting soon Observational

Hemodynamic Responses and Brain Activity During Dual Tasks in COPD Patients Versus Healthy Individuals

NCT06974448 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-05-15
Last updated
2025-05-16

Condition(s) studied

COPD - Chronic Obstructive Pulmonary DiseaseHealty Controls

Study summary

Abstract

Cognitive dysfunction is joint in patients with chronic obstructive pulmonary disease (COPD).

In particular, there are effects in tasks that require attention, executive functions, and working memory related to the prefrontal cortex. These effects make it difficult to perform two tasks simultaneously and cause performance errors. The number of studies investigating the effects of cognitive impairments on dual-task performance in COPD is limited. In these studies, no tests were applied specifically for attention and working memory areas; therefore, the brain's neural activity was not investigated during these tests. Multimodal approaches are recommended for a comprehensive assessment of the functional activity of the brain. Multimodal approaches provide more accurate results than single-modality approaches. In the integrated electroencephalography (EEG)-functional near-infrared spectroscopy (fNIRS) approach, EEG provides adequate temporal resolution, while fNIRS offers better spatial resolution and is robust to noise. There is no study in COPD where simultaneous fNIRS-EEG measurements were made during both cognitive tests and dual tasks. In our study, the simultaneous measurement of frontal hemodynamic responses and electrical brain activity in both cognitive tests and dual-task conditions and the examination of the relationship between the results and arterial stiffness, balance, exercise capacity, anxiety, depression, and quality of life scores, which are reported to be related to cognitive function in COPD, constitute the original aspect of our study. The study will include 16 COPD and 16 healthy individuals. The same assessments will be made in both groups, and the results will be compared. General and task-specific cognitive tests, prefrontal cortex oxygenation (fNIRS), electrical brain activity (EEG), exercise capacity, muscle oxygenation, arterial stiffness, balance, respiratory function, dyspnea, depression, anxiety, and quality of life will be evaluated. As a result of this study is expected to determine the effects of cognitive function and dual-task on frontal hemodynamic responses and electrical brain activity in COPD.

Eligibility

Sex
ALL
Min age
40 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria for the COPD Group: * Being diagnosed with COPD * Being between the ages of 40-65 * Not having a history of exacerbations in the last 4 week * Being willing to participate in the study Inclusion criteria for the Control Group * Being between the ages of 40-65 * Being willing to participate in the study Exclusion Criteria for COPD Group : * Known alpha-1 anti-trypsin deficiency * Presence of ischemic heart disease, uncontrolled hypertension, and diabetes mellitus * Presence of obstructive sleep apnea syndrome * Untreated tumors * Known history of dementia * Existing musculoskeletal, neuromuscular, or neurological diseases that may prevent participation in the tests * Not being willing to participate in the study Exclusion criteria for the Control Group: * Having a known chronic health problem * Not being willing to participate in the study

Primary outcome measure(s)

  • Mini-Mental State Examination (MMST) — through study completion, an average of 1 year
    The Mini-Mental State Examination (MMST) will be used for general cognitive status assessment. MMST consists of 11 items grouped under five main headings (execution, recording memory, attention and calculation, recall and language). The total score is obtained by adding the scores obtained by the patient from each item. It is evaluated out of a total of 30 points.The Turkish version of the test will be used
  • Montreal Cognitive Assessment Scale (MoCA) — through study completion, an average of 1 year
    MoCA, the presence of cognitive impairment will be evaluated using the MoCA scale. The scale is scored between 0 and 30 points. The application time of the scale is approximately 10 minutes and includes six cognitive functions. The cognitive functions evaluated in the scale are memory, visual-spatial skills, executive functions, attention, concentration and working memory tasks, language and orientation. The Turkish version of the scale will be used.
  • Stroop test — through study completion, an average of 1 year
    The Stroop test is a widely used test to evaluate executive functions of the frontal region, such as selective attention, information processing speed, cognitive flexibility, and the ability to resist interference. It is one of the tests considered the gold standard for measuring a person's attention. It is especially preferred to measure executive control in a situation that creates cognitive conflict. In the Stroop test, the person is expected to shift their attention to the color of the ink the word is written in, rather than the semantic meaning. When there is a conflict between visual information (the color of the ink the word is written in) and semantic information (the meaning of the word), the person's response is delayed or gives an incorrect answer.
  • N back test — through study completion, an average of 1 year
    The N-back test has been used in both experimental and neuroimaging studies as a measure of working memory ability and has been called the gold standard technique for the assessment of working memory. The study will use a "0-back and 2-back task". During this test, the participant is expected to respond if the stimulus shown on the screen overlaps with the stimulus shown 'n' times before. Various letters were selected as stimuli. The visual stimulus appeared on the screen for 500 milliseconds (msec), with a 2000 msec waiting period between the two stimuli. All participants will be initially informed about the task, then given a practice test, and will proceed to the main test after at least three correct responses. No intervention will be made during the main test. In the evaluation of this test, the number of correct hits and false alarms will be determined according to the participant's responses, and correct hit and false alarm scores will be calculated using these data.
  • Evaluation of hemodynamic responses in brain oxygenation — through study completion, an average of 1 year
    Functional Near Infrared Spectroscopy (fNIRS) will evaluate hemodynamic responses in brain oxygenation. FNIRS examinations measure hemodynamic responses (oxyhemoglobin and deoxyhemoglobin) in brain oxygenation to be able to transmit physical activity. It is a non-invasive optical imaging technique that allows real-time assessment of brain capacity. This will be an economical, high-durability (Artinis, Brite, Netherlands) wired 27-channel dual-wave length (760 and 850 nm) continuous wave (CW-fNIRS) system. Measurement will be performed during the cognitive , single and dual tasks.
  • Evaluation of Changes in Brain Electrical Activity-Electroencephalography (EEG) — through study completion, an average of 1 year
    EEG is a measurement of electrical activity in the brain that records the frequencies observed during normal brain activity. EEG signals will be collected using a 32-channel EEG device (Mobile EEG Enobio, Neuroelectrics, Barcelona, Spain), portable, wireless data acquisition system at a sample rate of 250 Hz. The EEG device will be synchronized using e-PRIME (Physiology Software Tools. Brain waves are divided into delta (0-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), low beta (12-16 Hz), high beta (16-25 Hz) and gamma (25-50 Hz) waves.The constituent factors of cognitive load will be measured separately in terms of the degree of activation of brain waves according to frequency. Measurement will be performed during the cognitive, single and dual tasks.

Trial sites (1)

FacilityCityRegionStatus
Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara Turkey (Türkiye)

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06974448 on ClinicalTrials.gov ↗ ← All trials in Turkey