A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI
SCI-IQ
Intervening Quickly: A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI
1 other identifier
interventional
24
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2024
CompletedFirst Posted
Study publicly available on registry
February 2, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedJune 6, 2024
June 1, 2024
1.1 years
January 26, 2024
June 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Useful Field of View (UFOV)
computerized processing speed task
baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Letter & Pattern Comparison (LPC)
processing speed task, using both letter and pattern strings
baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Symbol Digit Modalities Test (SDMT)
processing speed task, matching numbers to symbols using a key
baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Secondary Outcomes (1)
Spinal Cord Injury Quality of Life scales
baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Study Arms (2)
Experimental
EXPERIMENTALpre-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
Placebo Control
PLACEBO COMPARATORpre-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
Interventions
Eligibility Criteria
You may qualify if:
- years old
- recent traumatic SCI (approximately 6 months post-injury)
You may not qualify if:
- no other significant neurological, psychiatric or substance use history
- no significantly impairing visual disturbance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kessler Foundationlead
- Craig Hospitalcollaborator
- University of Washingtoncollaborator
Study Sites (3)
Craig Hospital
Englewood, Colorado, 80113, United States
Kessler Foundation
East Hanover, New Jersey, 07936, United States
University of Washington
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erica Weber, PhD
Kessler Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
January 26, 2024
First Posted
February 2, 2024
Study Start
April 1, 2024
Primary Completion
April 29, 2025
Study Completion
October 31, 2025
Last Updated
June 6, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share