MedPath

A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI

Not Applicable
Recruiting
Conditions
Spinal Cord Injuries
Cognitive Impairment
Acute Spinal Cord Injury
Cognitive Dysfunction
Interventions
Behavioral: game-like computerized activities
Behavioral: Placebo
Registration Number
NCT06238492
Lead Sponsor
Kessler Foundation
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
24
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimentalgame-like computerized activitiespre-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 ControlPlacebopre-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
Primary Outcome Measures
NameTimeMethod
Symbol Digit Modalities Test (SDMT)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)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)baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)

computerized processing speed task

Secondary Outcome Measures
NameTimeMethod
Spinal Cord Injury Quality of Life scalesbaseline to immediate post-treatment (week 13) and long-term follow-up (week 25)

self-reported instruments of quality of life after SCI

Trial Locations

Locations (3)

Kessler Foundation

🇺🇸

East Hanover, New Jersey, United States

Craig Hospital

🇺🇸

Englewood, Colorado, United States

University of Washington

🇺🇸

Seattle, Washington, United States

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