Cognitive Impairment Clinical Trial
— BROCA-iOfficial 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).
Status | Recruiting |
Enrollment | 4 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 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.) - 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 Exclusion Criteria: 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 - 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). |
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Hospital | Arnhem | Gelderland |
Netherlands | Adelante | Hoensbroek | Limburg |
Netherlands | Maastricht University | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University | Adelante, Centre of Expertise in Rehabilitation and Audiology, Maastricht University Medical Center, Rijnstate Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in neuropsychological assessment score: Memory, Auditory Verbal Learning Test | Before baseline (< day 1), immediately after baseline, after intervention, immediately after follow up. The patient has to remember a list of words. This measures immediate recall, retention, and recognition.
Unit: amount of correct words recalled and recognized. |
< day 1 (before baseline), after baseline (day 15-35 depending on the randomisation), after intervention (day 57 - 77 depending on the randomisation), after follow-up (day 150) | |
Other | Change in neuropsychological assessment score: Memory, Rivermead Behavioural Memory Test-Stories | Before baseline (< day 1). The patient has to try to remember a short newspaper article.
Unit: amount of correct information given. |
< day 1 (before baseline) | |
Other | Change in neuropsychological assessment score: executive functioning, Digit Span backward | Before baseline (< day 1): Digit Span backward (executive functioning).
The patient has to repeat a row of numbers in the opposite order. Unit: length of the longest number sequence the patient completes successfully. |
< day 1 (before baseline) | |
Other | Change in neuropsychological assessment score: executive functioning, Letter Fluency task | Before baseline (< day 1), immediately after baseline, immediately after intervention, immediately after follow-up.
The patient is asked to name as many things as possible in 1 minute that start with a certain letter. Unit: amount of correct words named |
< day 1 (before baseline), after baseline (day 15-35 depending on the randomisation), after intervention (day 57 - 77 depending on the randomisation), after follow-up (day 150) | |
Other | Change in neuropsychological assessment score: attention, digit span forward | Before baseline (< day 1), immediately after baseline, immediately after intervention, immediately after follow-up.
The patient has to recall a sequence of number in the same order. Unit: length of the longest number sequence the patient completes successfully |
< day 1 (before baseline), after baseline (day 15-35 depending on the randomisation), after intervention (day 57 - 77 depending on the randomisation), after follow-up (day 150) | |
Other | Change in neuropsychological assessment score: attention, Digit Symbol coding task | Before baseline (< day 1): Digit Symbol coding task (attention)
The patient has to complete as many rows of symbols by giving them the corresponding digit within two minutes. Unit: The amount of symbols correctly coded within 2 minutes |
< day 1 (before baseline) | |
Other | Change in Questionnaires: cognitive complaints | CLC_IC: Checklijst Cognitie-Intensive care questionnaire to assess cognitive complaints
Range: 0 - 10, higher scores indicate a worse outcome. |
< day 1 (before baseline), after baseline (day 15-35 depending on the randomisation), after intervention (day 57 - 77 depending on the randomisation), after follow-up (day 150) | |
Other | Change in Questionnaires: memory complaints | the Everyday Memory Questionnaire-revised (EMQ-r) for subjective memory complaints.
Range: 0 - 52 , higher scores indicate a worse outcome |
< day 1 (before baseline), after baseline (day 15-35 depending on the randomisation), after intervention (day 57 - 77 depending on the randomisation), after follow-up (day 150) | |
Other | Change in Questionnaires: participation | Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)- restriction questionnaire measures participation.
Range: 0 - 100, a higher score indicates better outcome |
< day 1 (before baseline), after baseline (day 15-35 depending on the randomisation), after intervention (day 57 - 77 depending on the randomisation), after follow-up (day 150) | |
Other | Change in Questionnaires: quality of life | The Life Satisfaction Questionnaire (LiSat-9) measures quality of life.
Range: 1-6, a higher score indicates better outcome |
< day 1 (before baseline), after baseline (day 15-35 depending on the randomisation), after intervention (day 57 - 77 depending on the randomisation), after follow-up (day 150) | |
Other | Change in MRI-data, DTI | These data will be used to assess brain structural and functional connectivity, including spatiotemporal characteristics of cerebral rearrangements that associate with cognitive recovery. During a ±30 minute scan, the investigators will collect measures of resting state functional connectivity and structural integrity of white matter tracts with blood oxygenation level-dependent (BOLD) MRI and diffusion tensor imaging (DTI) on a clinical 3T scanner. Functional connectivity will be expressed in a region-based way and at a whole network level. The architecture of neuronal fibers will be based on DTI-derived diffusion anisotropy, principle diffusion direction in white matter, and tractography algorithms. | before baseline (< day 1), after follow-up (day 150) | |
Other | Demographics; age | age in years | before baseline (< day 1) | |
Other | Demographics; level of education | level of education according to Verhage. | before baseline (< day 1) | |
Other | Demographics; handedness | handedness: left, right, or both | before baseline (< day 1) | |
Other | Demographics; Living situation | living situation: alone, with partner, with partner and children, with other residents. | before baseline (< day 1) | |
Other | Medical history; time since OHCA | the time since the OHCA in months | before baseline (< day 1) | |
Other | Medical history; ROSC | Time till return of spontaneous circulation in minutes | before baseline (< day 1) | |
Other | Medical history; cause OHCA | Cause of cardiac arrest | before baseline (< day 1) | |
Other | Medical history; hospitalization length | Duration of comatose state and hospitalization in days | before baseline (< day 1) | |
Other | Medical history; implantations | The presence of any implantations or objects in the body. If so, what kind of implantation/object? | before baseline (< day 1) | |
Other | Medical history; Comorbidity | Any other disorders or illnesses besides the OHCA. | before baseline (< day 1) | |
Primary | 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. | 85 measurements in 150 days | |
Secondary | 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. | 85 measurements in 150 days | |
Secondary | 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). | 85 measurements in 150 days |
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