Brain Outcome After Cardiac Arrest - Intervention — BROCA-i  

Cognitive Impairment Clinical Trial

Official title: BROCA-intervention Brain Outcome After Cardiac Arrest- Single Case Experimental Design Intervention Study

Status Recruiting

Clinical Trial Summary

People who suffered a cardiac arrest are often have cognitive impairments. In this study the investigators test the effectiveness of an intervention, combining direct training and metacognitive training, in a single case experimental design (SCED).

Clinical Trial Description

SUMMARY

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 test effectiveness of cognitive rehabilitation therapy to improve functioning on problematic well-defined personalized behaviour that is caused by an objective cognitive impairments after OHCA. Secondary objectives are to test the generalisation of the effect of the intervention towards other aspects of daily living, to estimate the effect of the intervention on objective and subjective measures of cognitive functioning, participation in society, and quality of life, and to detect evidence of neuroplasticity in MRI data.

Study design: This is a randomized multiple baseline single case experimental design (SCED) intervention study.

Study population: The four to six participants included in this study will be patients surviving a cardiac arrest and cardiopulmonary resuscitation with remaining cognitive impairments at least 3 months after the cardiac arrest, who are motivated to adhere to the training program tested in this study.

Intervention: The intervention will consist of a combination of direct training of the impaired cognitive function(s) and metacognitive strategy training for 42 days (6 weeks). Direct training will be done with the computer program Rehacom to train the impaired cognitive domains, for 20 minutes 5 times a week. Metacognitive strategy training will be given on a weekly or biweekly basis (6-10 sessions) by a trained therapist as current care.

Main study parameters/endpoints: The primary outcome measure is the score on a Visual Analogue Scale (VAS) of the severity of the main, predefined daily life problem caused by objective cognitive impairment(s) that the participant is dealing with. The primary outcome measure will be collected by an App, through which the patient will receive questions on his / her telephone, daily. Answering will take less than one minute. Secondary outcome measures are daily obtained VAS scores on general and potential other daily life problems, and scores on neuropsychological tests and questionnaires that are obtained four times during the study, and MRI data obtained at two different time-points.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators foresee no relevant additional risk of cognitive rehabilitation therapy and follow up in this study. Daily training and collection of outcomes will be challenging, but feasible, since the investigators will include motivated patients who will mostly judge the careful follow up as pleasant and attentive. MRI scanning is only performed in patients suitable for scanning, no contrasts are used. Potential benefit from participation in this study is follow up and treatment of cognitive impairments may lead to improved functional recovery after cardiac arrest. ;

Related Conditions & MeSH terms

• Cognitive Impairment
• Heart Arrest
• Heart Arrest, Out-Of-Hospital
• Out-of-Hospital Cardiac Arrest

• NCT number: NCT05133869
• Study type: Interventional
• Source: Maastricht University
• Contact: Caroline van Heugten, prof
• Phone: 31-43-3884091
• Email: caroline.vanheugten@maastrichtuniversity.nl
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2022
• Completion date: July 2024