Clinical trial NCT06238492: A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI
Official title: Intervening Quickly: A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Cognitive Dysfunction
Cognitive Impairment
Acute Spinal Cord Injury
Keywords: processing speed
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Craig Hospital
name: University of Washington
First posted: 2024-02-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Useful Field of View (UFOV)
timeFrame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
measure: Letter & Pattern Comparison (LPC)
timeFrame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Secondary outcomes:
measure: Spinal Cord Injury Quality of Life scales
timeFrame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Kessler Foundation
name: Erica Weber, PhD
role: PRINCIPAL_INVESTIGATOR
References: