Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-30 @ 1:00 PM
Study NCT ID:
NCT04229056
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2020-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPuter-assisted Self-training to Improve EXecutive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Because of the nature of the intervention, masking participants and investigators is not possible. Outcome assessors will be masked to the group allocation of participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two parallel groups will be included in this study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 307}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CABPad Working Memory Test', 'timeFrame': 'After the end of the intervention (8 weeks after baseline)', 'description': 'Test of working memory. The higher score the better (theoretically infinite score)'}], 'secondaryOutcomes': [{'measure': 'CABPad Working Memory Test - 3 months follow-up', 'timeFrame': 'At follow-up visit 3 months after end of intervention', 'description': 'Test of working memory. The higher score the better (theoretically infinite score)'}, {'measure': 'Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.'}, {'measure': 'Trail Making A', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Test of processing speed and visual attention. The lower score the better (theoretically infinite score)'}, {'measure': 'Trail Making A', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Test of processing speed and visual attention. The lower score the better (theoretically infinite score)'}, {'measure': 'Trail Making B', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)'}, {'measure': 'Trail Making B', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)'}, {'measure': 'SDMT', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)'}, {'measure': 'SDMT', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)'}, {'measure': 'Phonological verbal fluency test', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Test of verbal phonological fluency. The higher score the better (theoretically infinite score)'}, {'measure': 'Phonological verbal fluency test', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Test of verbal phonological fluency. The higher score the better (theoretically infinite score)'}, {'measure': 'Categorical verbal fluency test', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Test of verbal categorical fluency. The higher score the better (theoretically infinite score)'}, {'measure': 'Categorical verbal fluency test', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Test of verbal categorical fluency. The higher score the better (theoretically infinite score)'}, {'measure': 'Fear questionnaire', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear'}, {'measure': 'Fear questionnaire', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear'}, {'measure': 'mrs: Modified Rankin Scale', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead): Higher score indicates more severe disability.'}, {'measure': 'mrs: Modified Rankin Scale', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead). Higher score indicates more severe disability.'}, {'measure': 'IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Cognitive decline in the elderly, reported by partner. A scale of 16 items from 1 (much better) to 5 (much worse). Higher score indicates more severe disability.'}, {'measure': 'IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Cognitive decline in the elderly, reported by partner. A scale of 16 items from 1 (much better) to 5 (much worse). Higher score indicates more severe disability.'}, {'measure': 'EuroQol-5 domain (EQ-5D-5L)', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disability . Higher score indicates more severe disability. Completed by patient and partner'}, {'measure': 'EuroQol-5 domain (EQ-5D-5L)', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disability. Higher score indicates more severe disability. Completed by patient and partner'}, {'measure': 'PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease)', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': "Quality of Life questionnaire in patients with Parkinson's Disease. A scale with 39 items rated from 1 (never) to 5 (all the time / Can not do at all). Higher score indicates more severe disability."}, {'measure': 'PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease)', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': "Quality of Life questionnaire in patients with Parkinson's Disease. A scale with 39 items rated from 1 (never) to 5 (all the time / Can not do at all). Higher score indicates more severe disability."}, {'measure': 'Compliance', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Monitoring of total time spent training in minutes'}, {'measure': 'PHQ-9 (Patient health questionnaire 9)', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Questionnaire about health of patient with 9 items rated on a 4 point scale from 0 (not at all) to 3 (almost every day). Higher score indicates more severe disability.'}, {'measure': 'PHQ-9 (Patient health questionnaire 9)', 'timeFrame': 'At follow-up visit 3 months after the end of the intervention', 'description': 'Questionnaire about health of patient with 9 items rated on a 4 point scale from 0 (not at all) to 3 (almost every day). Higher score indicates more severe disability.'}, {'measure': '2) visual analogue scale (1-10)', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'After last session: how much they liked doing the training and if they would recommend the intervention to somebody else in their situation. Higher score indicates they liked the training more.'}, {'measure': 'Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)', 'timeFrame': 'Directly after the intervention, eight weeks after inclusion', 'description': 'Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['parkinson disease', 'stroke', 'cardiac arrest', 'executive dysfunction', 'cognitive dysfunction', 'computer-based cognitive rehabilitation'], 'conditions': ['Parkinson Disease', 'Stroke', 'Cardiac Arrest', 'Cognitive Dysfunction', 'Executive Dysfunction']}, 'descriptionModule': {'briefSummary': "This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to generally cognitively stimulating activities on a computer", 'detailedDescription': "This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to completing generally cognitively stimulating activities on a computer. A total of 307 patients is expected to be enrolled. All patients will complete a neuropsychological test battery assessing executive functions at inclusion, directly after the eight-week training period and at follow-up three months after the end of the intervention period. Furthermore, all patients will answer questionnaires concerning quality of life and ADL-measures at baseline, after the intervention and at follow-up. All patients will train for a period of 8 weeks, 5 times a week for 60 minutes regardless of their group allocation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A diagnose of stroke, cardiac arrest or Parkinson's disease.\n* Aged 18 years or older.\n* Impaired working memory measured with CABPad working memory test, cut off for inclusion: 5 symbols or less backwards\n* Computer and internet access at home.\n* Providing informed consent.\n\nInclusion criteria specific for stroke\n\n* Inclusion within 6 months post-stroke\n* Stroke confirmed by clinical findings and imaging, both AIS and ICH is allowed.\n* Initial stroke severity \\>/= NIHSS 3.\n\nInclusion criteria specific for cardiac arrest\n\n• Inclusion within 6 months post ictus.\n\nInclusion criteria specific for Parkinson's disease\n\n* Clinical diagnosis of PD.\n* Anti-parkinsonian medical treatment (dopaminergic or other).\n\nExclusion Criteria:\n\n* Informed consent not provided\n* Other neurological or psychiatric disease which is expected to influence the patient's ability to participate in the trial according to the investigator\n* Not able to participate according to investigator\n\nExclusion criteria specific for stroke\n\n* Patients with massive anosognosia for executive dysfunction or patients with no subjective feeling of executive dysfunction (Patient sustains total denial of executive symptoms over time)\n* Patients with severe aphasia, in which it is unclear whether the patient's performance on a neuropsychological test-battery is due to aphasia and not executive dysfunction.\n\nExclusion criteria specific for cardiac arrest • None\n\nExclusion criteria specific for PD\n\n• Diagnosis of PD Dementia according to the MDS PD Dementia criteria"}, 'identificationModule': {'nctId': 'NCT04229056', 'acronym': 'COMPEX', 'briefTitle': 'COMPuter-assisted Self-training to Improve EXecutive Function', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': "Computer-Assisted Self-Training to Improve Executive Function Versus Unspecific Training in Patients After Stroke, Cardiac Arrest or in Parkinson's Disease: a Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'H-19039236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Specific computer-based cognitive rehabilitation', 'description': "154 patients will be allocated to specific computer-based cognitive rehabilitation. This group will train with 10 exercises from the cognitive rehabilitation software 'Scientific Brain training PRO'. These 10 exercises are designed to train various executive functions.", 'interventionNames': ['Behavioral: Computer-based cognitive rehabilitation (CBCR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General computer-based cognitive stimulation', 'description': '154 patients will be allocated to general computer-based cognitive stimulation. This group will train with 10 generally mentally stimulating games on a website specifically designed for this trial. These 10 games are chosen because they are believed to have a low load on executive functions but stimulate over-all concentration and visuoperceptual abilities.', 'interventionNames': ['Behavioral: General computer-based cognitive stimulation']}], 'interventions': [{'name': 'Computer-based cognitive rehabilitation (CBCR)', 'type': 'BEHAVIORAL', 'description': 'CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.', 'armGroupLabels': ['Specific computer-based cognitive rehabilitation']}, {'name': 'General computer-based cognitive stimulation', 'type': 'BEHAVIORAL', 'description': 'For this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation.', 'armGroupLabels': ['General computer-based cognitive stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Hanne Christensen, MD, Professor', 'role': 'CONTACT'}], 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jesper Kjaergaard, MD', 'role': 'CONTACT'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Hanne Christensen, Professor', 'role': 'CONTACT', 'email': 'hanne.krarup.christensen@regionh.dk', 'phone': '+45 38 63 50 70'}, {'name': 'Katrine Sværke, M.Sc. Psych.', 'role': 'CONTACT', 'email': 'katrine.svaerke.schioeler@regionh.dk', 'phone': '004521251087'}], 'overallOfficials': [{'name': 'Hanne Christensen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This is currently undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'University of Glasgow', 'class': 'OTHER'}, {'name': 'University of Basel', 'class': 'OTHER'}, {'name': 'Copenhagen Trial Unit, Center for Clinical Intervention Research', 'class': 'OTHER'}, {'name': 'Hjernesagen', 'class': 'UNKNOWN'}, {'name': 'Göteborg University', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'Neurorehabilitering - Kbh, City of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hanne Christensen', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}