Early Intervention for Information Processing Speed Deficits in Acute SCI: A Pilot Study
SCI-IQ
1 other identifier
interventional
20
1 country
1
Brief Summary
This study seeks to 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 Jun 2024
Shorter than P25 for not_applicable
1 active site
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
June 5, 2024
CompletedFirst Posted
Study publicly available on registry
June 11, 2024
CompletedStudy Start
First participant enrolled
June 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedJune 21, 2024
June 1, 2024
5 months
June 5, 2024
June 19, 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 and 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 (SCI-QOL)
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
Study Sites (1)
Kessler Foundation
East Hanover, New Jersey, 07936, 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
- SPONSOR
Study Record Dates
First Submitted
June 5, 2024
First Posted
June 11, 2024
Study Start
June 19, 2024
Primary Completion
November 30, 2024
Study Completion
November 30, 2024
Last Updated
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share