Recruiting

Observational Study

Sponsor:

Kessler Foundation

Code:

NCT06452264

Conditions

Spinal Cord Injuries

Cognitive Dysfunction

Cognitive Impairment

Acute Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

game-like computerized activities

game-like computerized activities

Study Details

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.

Conditions

Spinal Cord Injuries

Cognitive Dysfunction

Cognitive Impairment

Acute Spinal Cord Injury

Study ID

NCT06452264

Start date

Jun 19, 2024

Status verified date

Jun, 2024

Completion date

Nov 30, 2024

Anticipated

Primary completion date

Nov 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

placebo comparator: 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

Interventions

game-like computerized activities

game-like computerized activities

game-like computerized activities

game-like computerized activities

Primary outcome measure

  • Useful Field of View (UFOV) [ Time Frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25) ]
  • Letter and Pattern Comparison (LPC) [ Time Frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25) ]
  • Symbol Digit Modalities Test (SDMT) [ Time Frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25) ]

Central Contacts and Locations

Central contacts

Erica Weber, PhD

6176453678eweber@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Sean Wallace

973-324-8441swallace@kesslerfoundation.org

Rebeca Costa

rcosta@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Jun 21, 2024

Last verified

Jun, 2024

Keywords

  • processing speed

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2024-06-21.