BROCA-intervention Brain Outcome After Cardiac Arrest- Single Case Experimental Design Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Change in main daily problem
研究概览
简要总结
People who suffered a cardiac arrest are often have cognitive impairments. In this study the investigators test the effectiveness of an intervention, combining direct training and metacognitive training, in a single case experimental design (SCED).
详细描述
SUMMARY
Rationale: The survival rate of patients after cardiac arrest and resuscitation has increased considerably. A common consequence of cardiac arrest is ischemic-hypoxic brain damage leading to cognitive impairment. Currently, there is a lack of knowledge regarding effectiveness of treatments to improve outcomes of patients with cognitive impairment after a cardiac arrest.
Objective: The primary objective is to test effectiveness of cognitive rehabilitation therapy to improve functioning on problematic well-defined personalized behaviour that is caused by an objective cognitive impairments after OHCA. Secondary objectives are to test the generalisation of the effect of the intervention towards other aspects of daily living, to estimate the effect of the intervention on objective and subjective measures of cognitive functioning, participation in society, and quality of life, and to detect evidence of neuroplasticity in MRI data.
Study design: This is a randomized multiple baseline single case experimental design (SCED) intervention study.
Study population: The four to six participants included in this study will be patients surviving a cardiac arrest and cardiopulmonary resuscitation with remaining cognitive impairments at least 3 months after the cardiac arrest, who are motivated to adhere to the training program tested in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All participants receive the same intervention, therefore there is no masking.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must be mentally competent and meet all of the following criteria:
- •Objectified cardiac arrest between 3 months and 2 years before inclusion.
- •Age 18 - 75
- •Cognitive impairments objectified by a score on the Montreal Cognitive Assessment (MoCA) ≤ 26 or abnormal scores on a neuropsychological assessment caused by low scores (more than 1,5 standard deviation below the mean of the norm group) on memory, attention, and/or executive functioning tasks
- •Living independently (with minor help)
- •Experiencing difficulties with more complex daily tasks (e.g. doing groceries, following conversations, etc.)
- •Motivated to improve cognitive functioning and to participate in the study
- •Proficient in Dutch to understand instructions, follow the training program and fill in the questionnaires
- •Patients with a treatment indication for cognitive rehabilitation (as decided by a psychiatrist)
- •Written informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Neurodegenerative disorder, or another brain disease known to impact cognition, such as stroke or dementia
- •Substance abuse impacting cognition
- •Psychiatric disorder in need of treatment
- •Uncorrected visual or auditory deficiencies
- •Not in possession of a computer or lack of computer skills
- •Severe amnesia or aphasia
- •Illiteracy
- •In case of MRI contra-indications, such as an ICD or metallic implants, patients will be excluded from the MRI sub-study. The full list of contraindications can be found in the article of Ghadimi and Sapra (2020).
结局指标
主要结局
Change in main daily problem
时间窗: 85 measurements in 150 days
A Visual Analogue Scale (VAS) from 0 to 100 with higher scores meaning a worse outcome, of the severity of the predefined daily life problem caused by an objective cognitive impairment that the participant is dealing with.
次要结局
- Change in general functioning(85 measurements in 150 days)
- Change in other daily problems(85 measurements in 150 days)