Brain Outcome After Cardiac Arrest. Modifying Working Memory With Non-invasive Brain Stimulation - A Series of SCEDs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrest
- Sponsor
- Maastricht University
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Accuracy on the N-back task
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participant has to come to the university twice. The screening session takes approximately 1-1,5 hour, the experimental session 3,5 hours. The participant could experience side effects of the rTMS, these include: headache, scalp discomfort, tingling or twitching of the facial muscles, and light-headedness. Serious side effects are very rare, but they may include: seizures. The N-back task can be experienced as tiring.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Accuracy on the N-back task
Time Frame: 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
Secondary Outcomes
- 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))