The Efficacy of Non-invasive Brain Stimulation on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease: Double-Blinded Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The battery of neurocognitive tests
研究概览
简要总结
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
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Non-invasive brain stimulation
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.
干预措施: Non-invasive brain stimulation (Device)
Sham Non-invasive brain stimulation
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.
干预措施: Sham Non-Invasive brain stimulation (Device)
结局指标
主要结局
The battery of neurocognitive tests
时间窗: At enrolment as baseline assessment and at the end of treatment at 3 weeks
• 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.
次要结局
- Cardiopulmonary exercise test (CPET)(At enrolment as baseline assessment and at the end of treatment at 3 weeks)
- Transcranial Doppler (TCD) ultrasound(At enrolment as baseline assessment and at the end of treatment at 3 weeks)
- Arterial blood gas analysis (ABGs)(At enrolment as baseline assessment and at the end of treatment at 3 weeks)
研究者
Shahad Abdulrahman Alkandari
Shahad Alkandari MSc, PT.
Ministry of Health, Kuwait