Early Intervention for Information Processing Speed Deficits in Acute SCI: A Pilot Study

NCT ID: NCT06452264

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-19
• Study Completion Date: 2024-11-30

Brief 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.

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 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

game-like computerized activities

Intervention Type: BEHAVIORAL

game-like computerized activities

Placebo Control

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

Group Type: PLACEBO_COMPARATOR

game-like computerized activities

Intervention Type: BEHAVIORAL

game-like computerized activities

Interventions

game-like computerized activities

game-like computerized activities

Intervention Type: BEHAVIORAL

game-like computerized activities

game-like computerized activities

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erica Weber, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

East Hanover, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erica Weber, PhD

Role: CONTACT

eweber@kesslerfoundation.org

6176453678

Facility Contacts

Sean Wallace

Role: primary

swallace@kesslerfoundation.org

973-324-8441

Rebeca Costa

Role: backup

rcosta@kesslerfoundation.org

Other Identifiers

R-1225-23

Identifier Type: -

Identifier Source: org_study_id