Modifying Working Memory With Brain Stimulation
- Conditions
- Cognitive ImpairmentCardiac Arrest
- Interventions
- Device: intermitted theta burst stimulation
- Registration Number
- NCT06119620
- Lead Sponsor
- Maastricht University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9
- 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 75.
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABAB intermitted theta burst stimulation all participants will go through sham (control) and active (experimental) stimulation. So either sham - active - sham - active or active - sham - active - sham
- Primary Outcome Measures
Name Time Method Accuracy on the N-back task 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 Outcome Measures
Name Time Method d' on the N-back task 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total) d' = z(False alarms) - z(Hits)
RT on the N-back task 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total) reaction time on the N-back task
Trial Locations
- Locations (1)
Maastricht University
🇳🇱Maastricht, Limburg, Netherlands