Actively Recruiting

Phase Not Applicable
Age: 18Years - 59Years
All Genders
ID06238492

Intervening Quickly: A Pilot Randomized Controlled Trial to Improve Cognitive Processing Speed in Acute Spinal Cord Injury

Led by Kessler Foundation · Updated on 2024-06-06

24

Participants Needed

3

Research Sites

26 weeks

Total Duration

On this page

Sponsors

K

Kessler Foundation

Lead Sponsor

C

Craig Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether a cognitive training program can improve processing speed in individuals who have recently experienced an acute traumatic spinal cord injury (SCI). This pilot randomized controlled trial aims to address cognitive difficulties such as attention, memory, and information processing speed, which can significantly impact rehabilitation outcomes and quality of life. The study focuses on early intervention to potentially enhance overall health and well-being for people with acute SCI. Participants are randomly assigned to one of two groups: an experimental group or a placebo control group. Both groups complete pre-specified game-like computerized tasks using an internet-based cognitive training portal. These sessions occur three times per week, lasting 60 minutes each, over a total of 12 weeks. The study uses a quadruple masking design to reduce bias. During the study, participants undergo assessments at baseline, immediately after treatment (week 13), and at long-term follow-up (week 25). Researchers measure processing speed using tests such as the Useful Field of View (UFOV), Letter & Pattern Comparison (LPC), and Symbol Digit Modalities Test (SDMT). Quality of life related to spinal cord injury is also evaluated. The total participation period spans approximately six months, including treatment and follow-up evaluations.

CONDITIONS

Brief Title

A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI

Who Can Participate

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 to 59 years old
  • Recent traumatic spinal cord injury, approximately within 6 months post-injury
Not Eligible

You will not qualify if you...

  • History of significant neurological, psychiatric, or substance use disorders
  • Significant vision problems that impair daily activities

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants complete pre-specified computer tasks using an Internet-based cognitive training portal, 3 times per week for 60 minutes each session over 12 weeks.

Regular sessions at home 3 times per week

Follow-up

Duration - 12 weeks

Participants are assessed for cognitive processing speed and quality of life after treatment and at long-term follow-up.

2 visits (at week 13 and week 25)

Trial Site Locations

Total: 3 locations

1

Craig Hospital

Englewood, Colorado, United States, 80113

Actively Recruiting

2

Kessler Foundation

East Hanover, New Jersey, United States, 07936

Actively Recruiting

3

University of Washington

Seattle, Washington, United States, 98105

Not Yet Recruiting

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Research Team

E

Erica Weber

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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