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A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI (SCI-IQ)

Kessler Foundation logo

Kessler Foundation

Status

Enrolling

Conditions

Cognitive Impairment
Spinal Cord Injuries
Cognitive Dysfunction
Acute Spinal Cord Injury

Treatments

Behavioral: game-like computerized activities
Behavioral: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06238492
R-1210-23

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 59 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

24 participants in 2 patient groups, including a placebo group

Experimental
Experimental group
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
Treatment:
Behavioral: game-like computerized activities
Placebo Control
Placebo Comparator group
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
Treatment:
Behavioral: Placebo

Trial contacts and locations

3

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Central trial contact

Erica Weber

Data sourced from clinicaltrials.gov

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