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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABAB | Other | all participants will go through sham (control) and active (experimental) stimulation. So either sham - active - sham - active or active - sham - active - sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermitted theta burst stimulation | Device | Participants receive intermitted theta burst stimulation for 3-4 minutes before completing the N-back task. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy on the N-back task | Percentage of correct responses for every 2 N-back blocks | 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total) |
| Measure | Description | Time Frame |
|---|---|---|
| RT on the N-back task | reaction time on the N-back task | 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total) |
| d' on the N-back task | d' = z(False alarms) - z(Hits) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pauline V van Gils, MSc | Contact | +31 (0)43 38 84095 | c.vangils@maastrichtuniversity.nl | |
| Caroline v van Heugten, Dr. prof. | Contact | +31 (0)43 388 4213 | c.vanheugten@maastrichtuniversity.nl |
| Name | Affiliation | Role |
|---|---|---|
| Caronline v van Heugten, Dr. prof. | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Recruiting | Maastricht | Limburg | Netherlands |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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This is a single case experimental design. All participants will receive both sham and active stimulation. The order of stimulation (sham, active, sham active OR active, sham, active, sham) will be randomised. Also the length of the N-back task is randomised between 8, 10, and 12 minutes).
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The participant won't be told if they receive sham or active stimulation.
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| 1 measurements every 2 minutes for 8 - 10 minutes after each N-back task (4 times in total) |
| D001523 |
| Mental Disorders |