A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI

Spinal Cord Injuries Clinical Trial

— SCI-IQ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238492
• Other study ID #: R-1210-23
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: June 2024
• Source: Kessler Foundation
• Contact: Erica Weber
• Phone: 973-324-8451
• Email: eweber[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 31, 2025
• Est. primary completion date: April 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Cognitive Dysfunction
• Cognitive Impairment
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• game-like computerized activities
Experimental
• Placebo
game-like computerized activities

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey
United States	Craig Hospital	Englewood	Colorado
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Kessler Foundation	Craig Hospital, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Useful Field of View (UFOV)	computerized processing speed task	baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Primary	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)
Primary	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	Spinal Cord Injury Quality of Life scales	self-reported instruments of quality of life after SCI	baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)