Skip to content

BROCA-intervention Brain Outcome after Cardiac Arrest- Single Case Experimental Design intervention study

BROCA-intervention Brain Outcome after Cardiac Arrest- Single Case Experimental Design intervention study - BROCA-intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54220
Enrollment
4
Registered
2021-11-04
Start date
2022-11-18
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hersenschade brain damage out of hospital cardiac arrest

Interventions

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 t

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a subject must be mentally competent and meet all of the following criteria: • Objectified cardiac arrest between 3 months and 2 years before inclusion. • Age 18 - 75 • Cognitive impairments objectified by a score on the Montreal Cognitive Assessment (MoCA)

Exclusion criteria

Exclusion criteria: • Neurodegenerative disorder, or another brain disease known to impact cognition, such as stroke • Substance abuse impacting cognition • Psychiatric disorder in need of treatment • Uncorrected visual or auditory deficiencies • Not in possession of a computer or lack of computer skills • Severe amnesia or aphasia • Illiteracy • • MRI contra-indications: o metal, magnetic, electric, or mechanic implants/objects in the body. o claustrophobia o pregnancy or breastfeeding

Design outcomes

Primary

MeasureTime frame
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 an objective cognitive deficit that the participant is dealing with. This problem is personalized for each participant, but is always related to an objective disturbance of attention, memory, and/or executive functioning. The VAS score varies between 0 and 10, 0 indicating no problem and 10 indicating the most severe problem imaginable. This VAS score is obtained daily via an app, before and during the intervention (phase A and B), and weekly to biweekly during the follow-up (phase C).

Secondary

MeasureTime frame
Secundary parameters: • Generalization measure: This variable is collected to test whether improved functioning on the primary outcome generalizes towards other aspects of daily functioning. This measure consists of other personal daily life problems caused by the objective cognitive impairment next to the primary outcome measure, and some general, non-personalized questions. The general questions are about the impaired cognitive domains (*To what extent did you experience problems with your memory / attention and concentration / planning and problem-solving since the last app notification?*). The generalization measure will be expressed as the score between 0 to 10 on three VAS, and also collected on a daily basis via an app before and during the intervention (phase A and B), and weekly to biweekly during the follow-up (phase C). Other study parameters • On the level of cognitive functioning: Before the intervention phase starts, the participant will complete a neuropsychological assessment consisting of the Auditory Verbal Learning Test (memory), Rivermead Stories (memory), Digit Span (attention and working memory), Coding task (attention), and Letter Fluency task (executive functioning) in order to provide modules that suit the patients impairment(s) and complaint(s). Before the intervention (start phase B), after the intervention (end phase B), and at 3 month follow up (end phase C), a small neuropsychological assessment will be done in order to establish changes within three cognitive domains: Letter Fluency task (executive functioning), Auditory Verbal Learning Test (memory), and Digit Span (attention and working memory). • The CLC-IC questionnaire will be administered at baseline (start phase A), before the intervention (start phase B), after the intervention (end phase B), and at 3 month follow up (end phase C), to assess the cognitive complaints of the patient. It consists of 10 multiple choice (*yes* or *no*) questions, and 2 op

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)