Early Intervention for Information Processing Speed Deficits in Acute SCI: A Pilot Study (SCI-IQ)

June 19, 2024 updated by: Kessler Foundation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: game-like computerized activities
game-like computerized activities
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
Behavioral: game-like computerized activities
game-like computerized activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Useful Field of View (UFOV)
Time Frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
computerized processing speed task
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)
processing speed task, matching numbers to symbols using a key
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)
processing speed task, using both letter and pattern strings
baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal Cord Injury Quality of Life scales (SCI-QOL)
Time Frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
self-reported instruments of quality of life after SCI
baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Investigators

  • Principal Investigator: Erica Weber, PhD, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-1225-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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