Modifying Working Memory With Brain Stimulation — BROCA-NIBS  

Cognitive Impairment Clinical Trial

Official title: Brain Outcome After Cardiac Arrest. Modifying Working Memory With Non-invasive Brain Stimulation - A Series of SCEDs

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cardiac Arrest
• Cognitive Impairment
• Heart Arrest

• NCT number: NCT06119620
• Study type: Interventional
• Source: Maastricht University
• Contact: Pauline V van Gils, MSc
• Phone: +31 (0)43 38 84095
• Email: c.vangils@maastrichtuniversity.nl
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Completion date: October 1, 2024