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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06452264
Other study ID # R-1225-23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 19, 2024
Est. completion date November 30, 2024

Study information

Verified date June 2024
Source Kessler Foundation
Contact Erica Weber, PhD
Phone 6176453678
Email eweber@kesslerfoundation.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study seeks to 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 to 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 20
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 18-65 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


Intervention

Behavioral:
game-like computerized activities
game-like computerized activities
game-like computerized activities
game-like computerized activities

Locations

Country Name City State
United States Kessler Foundation East Hanover New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Kessler Foundation

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 and 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 (SCI-QOL) self-reported instruments of quality of life after SCI baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
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