Brain Outcome After Cardiac Arrest. Modifying Working Memory With Non-invasive Brain Stimulation - A Series of SCEDs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Accuracy on the N-back task
研究概览
简要总结
The investigators want to investigate the effect of rTMS on working memory measured by the N-back task. This is a single case experimental design, ABAB.
详细描述
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 investigate the effects of rTMS (iTBS protocol) on working memory of people with memory impairments after a cardiac arrest in the past Study design: This will be a single blinded replicated randomized SCED withdrawal designs study.
Study population: Nine adults who had a cardiac arrest in the past will be participating in this study. They are recruited in the general population.
Intervention: If participants are suitable based on the screening. Participants are invited to the university of Maastricht. There they receive intermitted theta burst stimulation with a TMS coil for 3 minutes on the dorsolateral prefrontal cortex. Then they perform the N-back task for 8 to 12 minutes to estimate working-memory performance. Then they have a break (45 min). Then they receive 3 minutes of sham stimulation after which they have to perform the N-back task again for 8 - 12 minutes. This will be repeated (active stimulation - sham - active stimulation - sham).
Main study parameter: The main study outcomes are performance on the N-back task with regard to accuracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The participant won't be told if they receive sham or active stimulation.
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
- 是
入选标准
- •Had a cardiac arrest between 3 months and 5 years prior to the experiment session.
- •Scores lower than the general population (corrected for age, education, and sex) on at least one of the cognitive tests ( SD < -1 on the Stroop, digit span, or TMT).
- •Age 18 up to and including
- •Proficient in Dutch or English to understand the instructions for the N-back task.
- •Has sufficient understanding to perform the N-back task.
- •Written informed consent
排除标准
- •Has a pacemaker or ICD (implantable cardioverter-defibrillator)
- •A history or a family member with a history of seizures / epilepsy (asked on the phone and checked on the first appointment).
- •Metal implants in or near the head.
- •Pregnancy
- •Any other neurological disorder impending working memory performance besides the OHCA.
结局指标
主要结局
Accuracy on the N-back task
时间窗: 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total)
Percentage of correct responses for every 2 N-back blocks
次要结局
- d' on the N-back task(1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total))
- RT on the N-back task(1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total))