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A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06238492
Acronym
SCI-IQ
Enrollment
24
Registered
2024-02-02
Start date
2024-04-01
Completion date
2025-10-31
Last updated
2024-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Spinal Cord Injury, Cognitive Dysfunction, Cognitive Impairment, Spinal Cord Injuries

Keywords

processing speed

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.

Interventions

Experimental

BEHAVIORALPlacebo

game-like computerized activities

Sponsors

Craig Hospital
CollaboratorOTHER
University of Washington
CollaboratorOTHER
Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Useful Field of View (UFOV)baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)computerized processing speed task
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
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

Secondary

MeasureTime frameDescription
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

Countries

United States

Contacts

Primary ContactErica Weber
eweber@kesslerfoundation.org973-324-8451

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026