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Clinical Trials/NCT06238492
NCT06238492
Recruiting
N/A

Intervening Quickly: A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI

Kessler Foundation3 sites in 1 country24 target enrollmentApril 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Kessler Foundation
Enrollment
24
Locations
3
Primary Endpoint
Symbol Digit Modalities Test (SDMT)
Status
Recruiting
Last Updated
last year

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
October 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Principal Investigator
Principal Investigator

Erica Weber

Research Scientist

Kessler Foundation

Eligibility Criteria

Inclusion Criteria

  • 18-59 years old
  • recent traumatic SCI (approximately 6 months post-injury)

Exclusion Criteria

  • no other significant neurological, psychiatric or substance use history
  • no significantly impairing visual disturbance

Outcomes

Primary Outcomes

Symbol Digit Modalities Test (SDMT)

Time Frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)

processing speed task, matching numbers to symbols using a key

Letter & Pattern Comparison (LPC)

Time Frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)

processing speed task, using both letter and pattern strings

Useful Field of View (UFOV)

Time Frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)

computerized processing speed task

Secondary Outcomes

  • Spinal Cord Injury Quality of Life scales(baseline to immediate post-treatment (week 13) and long-term follow-up (week 25))

Study Sites (3)

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