Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
Study NCT ID:
NCT06238492
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-01-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Useful Field of View (UFOV)', 'timeFrame': 'baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)', 'description': 'computerized processing speed task'}, {'measure': 'Letter & Pattern Comparison (LPC)', 'timeFrame': 'baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)', 'description': 'processing speed task, using both letter and pattern strings'}, {'measure': 'Symbol Digit Modalities Test (SDMT)', 'timeFrame': 'baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)', 'description': 'processing speed task, matching numbers to symbols using a key'}], 'secondaryOutcomes': [{'measure': 'Spinal Cord Injury Quality of Life scales', 'timeFrame': 'baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)', 'description': 'self-reported instruments of quality of life after SCI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['processing speed'], 'conditions': ['Spinal Cord Injuries', 'Cognitive Dysfunction', 'Cognitive Impairment', 'Acute Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'This study seeks conduct a pilot study to test whether a cognitive training program can improve processing speed abilities in individuals with acute traumatic spinal cord injury.', 'detailedDescription': 'Spinal cord injury (SCI) newly affects approximately 18,000 persons in the US per year. Decades of research have focused on the physical limitations associated with SCI, as well as therapies for addressing these physical problems. However, it is becoming better acknowledged that many individuals experience significant problems with their cognitive abilities, such as attention, memory, and the time it takes them to process information. Research has shown that people who have cognitive difficulties, compared to those with a purely physical disability, are less likely to be employed, engage in fewer social and work-related activities, have greater difficulties carrying out routine household tasks, and are at higher risk for mental illness. If cognitive issues arise after an SCI, it is more likely that a person would have a more challenging time adapting the many lifestyle changes brought about by their injury, would benefit less from their rehabilitation program, and have more difficulty rejoining the workforce. As it stands, cognitive assessment or rehabilitation is not part of the standard of care for individuals after their SCI because of the relative lack of research in this area. This study seeks conduct a multisite pilot study to test whether a cognitive training program can improve processing speed abilities in individuals shortly after they experience their SCI, with the hopes that this early intervention will improve the trajectory of their overall health and well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-59 years old\n* recent traumatic SCI (approximately 6 months post-injury)\n\nExclusion Criteria:\n\n* no other significant neurological, psychiatric or substance use history\n* no significantly impairing visual disturbance'}, 'identificationModule': {'nctId': 'NCT06238492', 'acronym': 'SCI-IQ', 'briefTitle': 'A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI', 'organization': {'class': 'OTHER', 'fullName': 'Kessler Foundation'}, 'officialTitle': 'Intervening Quickly: A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI', 'orgStudyIdInfo': {'id': 'R-1210-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'pre-specified computer tasks using an Internet-based cognitive training portal, to be completed 3x per week for 60 minutes each session for 12 weeks total', 'interventionNames': ['Behavioral: game-like computerized activities']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'pre-specified computer tasks using an Internet-based cognitive training portal, to be completed 3x per week for 60 minutes each session for 12 weeks total', 'interventionNames': ['Behavioral: Placebo']}], 'interventions': [{'name': 'game-like computerized activities', 'type': 'BEHAVIORAL', 'description': 'Experimental', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo', 'type': 'BEHAVIORAL', 'description': 'game-like computerized activities', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abby Welch', 'role': 'CONTACT', 'email': 'awelch@craighospital.org', 'phone': '303-789-8039'}], 'facility': 'Craig Hospital', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sean Wallace', 'role': 'CONTACT', 'email': 'swallace@kesslerfoundation.org', 'phone': '973-324-8441'}, {'name': 'Rebeca Costa', 'role': 'CONTACT', 'email': 'rcosta@kesslerfoundation.org'}], 'facility': 'Kessler Foundation', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Flaster', 'role': 'CONTACT', 'email': 'aflaster@uw.edu', 'phone': '206-616-7934'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Erica Weber', 'role': 'CONTACT', 'email': 'eweber@kesslerfoundation.org', 'phone': '973-324-8451'}], 'overallOfficials': [{'name': 'Erica Weber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kessler Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kessler Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Craig Hospital', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Erica Weber', 'investigatorAffiliation': 'Kessler Foundation'}}}}