Heart Arrest, Out-Of-HospitalBROCA-iNCT05133869
Brain Outcome After Cardiac Arrest - Intervention
A study testing Metacognitive training + direct training in people with Heart Arrest, Out-Of-Hospital and Cognitive Impairment, run by Maastricht University at 3 sites in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Arrest, Out-Of-Hospital, Cognitive Impairment
- What is being tested?
- Metacognitive training + direct training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesNetherlands
- Study dates
- 21 Apr 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, 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) ≤ 26 or abnormal scores on a neuropsychological assessment caused by low scores (more than 1,5 standard deviation below the mean of the norm group) on memory, attention, and/or executive functioning tasks
- Living independently (with minor help)
- Experiencing difficulties with more complex daily tasks (e.g. doing groceries, following conversations, etc.)
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- Motivated to improve cognitive functioning and to participate in the study
- Proficient in Dutch to understand instructions, follow the training program and fill in the questionnaires
- Patients with a treatment indication for cognitive rehabilitation (as decided by a psychiatrist)
- Written informed consent
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Neurodegenerative disorder, or another brain disease known to impact cognition, such as stroke or dementia
- 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
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- Severe amnesia or aphasia
- Illiteracy
- In case of MRI contra-indications, such as an ICD or metallic implants, patients will be excluded from the MRI sub-study. The full list of contraindications can be found in the article of Ghadimi and Sapra (2020).
Trial locations and contacts
3 sites in 1 country.
Jeannette Hofmeijer, prof contact
Netherlands3 sites, 3 recruiting
- Recruiting
Rijnstate Hospital
Arnhem, Gelderland
Jeannette Hofmeijer, prof, Jhofmeijer@rijnstate.nl
- Not yet recruiting
Adelante
Hoensbroek, Limburg
Jeanine Verbunt, prof, jeanine.verbunt@maastrichtuniversity.nl
- Not yet recruiting
Maastricht University
Maastricht, Limburg
Pauline van Gils, Drs., 0031433884095, c.vangils@maastrichtuniversity.nl
Caroline van Heugten, Prof. Dr., +31-43-3884090, caroline.vanheugten@maastrichtuniversity.nl
About this study
Official title: BROCA-intervention Brain Outcome After Cardiac Arrest- Single Case Experimental Design Intervention Study
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).
Read the detailed 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.
- Being tested
- Metacognitive training + direct training
- Keywords
- Cardiac Arrest, Cognitive Rehabilitation, Neuroplasticity, Cognitive training
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Cognitive Dysfunction, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive training + direct trainingDevice
Also called Rehacom
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 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 at Adelante.
Rehacom is a brain training program developed to improve a variety of cognitive functions with the use of game-like cognitive training modules. During the intervention the participant should train with Rehacom for approximately 600 minutes in total.
In addition to the direct training, the participant receives six to ten sessions of metacognitive strategy training. During this training they are taught strategies by a therapist to improve their performance on the Rehacom modules and on daily life functioning. Each metacognitive strategy is linked to one of the Rehacom modules.
| Study group | Role | What they receive |
|---|---|---|
| Baseline + intervention + follow up | Experimental | All participants receive the same treatment in the same order. First there is a phase without treatment, the baseline phase. The length of this phase is randomly assigned to each participant. Then all participants follow a 42 day intervention, in which direct training and metacognitive training is combined. Afterwards they have a follow-up period, this length of this period is counterbalanced with the length of the baseline period so that the full study adds up to 150 days. Receives: Device: Metacognitive training + direct training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in main daily problem
A Visual Analogue Scale (VAS) from 0 to 100 with higher scores meaning a worse outcome, of the severity of the predefined daily life problem caused by an objective cognitive impairment that the participant is dealing with.
Measured: 85 measurements in 150 days
Secondary outcomes (2)
Change in other daily problems
This measure consists of a VAS from 0 to 100 with higher scores meaning a worse outcome, of other potential personal daily life problems caused by the objective cognitive impairment next to the primary outcome measure.
Measured: 85 measurements in 150 days
Change in general functioning
This measure consists of a VAS from 0 to 100 with higher scores meaning a worse outcome, of the problems in general cognitive domains (memory, planning/complex tasks, and attention).
Measured: 85 measurements in 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start21 Apr 2022
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a randomized multiple baseline single case experimental design (SCED) intervention study.
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital, Adelante, Centre of Expertise in Rehabilitation and Audiology, Maastricht University Medical Center
- Responsible party
- Sponsor
- Investigators
- Caroline van Heugten, prof, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133869
- Sponsor's protocol ID
- NL77453.068.21
- Acronym
- BROCA-i
- Status last verified
- Jan 2024
- First submitted
- 14 Sep 2021
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BROCA-intervention Brain Outcome After Cardiac Arrest- Single Case Experimental Design Intervention Study
- ClinicalTrials.gov ID
- NCT05133869
- Acronym / sponsor ID
- BROCA-i / NL77453.068.21
- Keywords
- Cardiac Arrest, Cognitive Rehabilitation, Neuroplasticity, Cognitive training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Rijnstate Hospital, Adelante, Centre of Expertise in Rehabilitation and Audiology, Maastricht University Medical Center
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a randomized multiple baseline single case experimental design (SCED) intervention study.
| Arm | Type | Receives |
|---|---|---|
| Baseline + intervention + follow up | Experimental | Device: Metacognitive training + direct trainingAll participants receive the same treatment in the same order. First there is a phase without treatment, the baseline phase. The length of this phase is randomly assigned to each participant. Then all participants follow a 42 day intervention, in which direct training and metacognitive training is combined. Afterwards they have a follow-up period, this length of this period is counterbalanced with the length of the baseline period so that the full study adds up to 150 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- In order to be eligible to participate in this study, 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) ≤ 26 or abnormal scores on a neuropsychological assessment caused by low scores (more than 1,5 standard deviation below the mean of the norm group) on memory, attention, and/or executive functioning tasks
- Living independently (with minor help)
Key exclusion criteria (9 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Neurodegenerative disorder, or another brain disease known to impact cognition, such as stroke or dementia
- Substance abuse impacting cognition
- Psychiatric disorder in need of treatment
- Uncorrected visual or auditory deficiencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive training + direct trainingAlso: RehacomThe 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 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 at Adelante. Rehacom is a brain training program developed to improve a variety of cognitive functions with the use of game-like cognitive training modules. During the intervention the participant should train with Rehacom for approximately 600 minutes in total. In addition to the direct training, the participant receives six to ten sessions of metacognitive strategy training. During this training they are taught strategies by a therapist to improve their performance on the Rehacom modules and on daily life functioning. Each metacognitive strategy is linked to one of the Rehacom modules. | Device | Baseline + intervention + follow up |
Primary outcome
Change in main daily problem
Time frame: 85 measurements in 150 days
A Visual Analogue Scale (VAS) from 0 to 100 with higher scores meaning a worse outcome, of the severity of the predefined daily life problem caused by an objective cognitive impairment that the participant is dealing with.
2 secondary outcomes
Change in other daily problems
Time frame: 85 measurements in 150 days
Change in general functioning
Time frame: 85 measurements in 150 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannette Hofmeijer, prof contact
Caroline van Heugten, prof principal investigator
Maastricht University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive training + direct training in people with Heart Arrest, Out-Of-Hospital and Cognitive Impairment, run by Maastricht University at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline van Heugten, prof (31-43-3884091, caroline.vanheugten@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in main daily problem (time frame: 85 measurements in 150 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.