A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI

NCT ID: NCT06238492

Last Updated: 2024-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-10-31

Brief Summary

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This study seeks 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

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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 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

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Spinal Cord Injuries Cognitive Dysfunction Cognitive Impairment Acute Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Experimental

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

Placebo

Intervention Type BEHAVIORAL

game-like computerized activities

Interventions

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game-like computerized activities

Experimental

Intervention Type BEHAVIORAL

Placebo

game-like computerized activities

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18-59 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

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Craig Hospital

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Erica Weber

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erica Weber, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

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Craig Hospital

Englewood, Colorado, United States

Site Status RECRUITING

Kessler Foundation

East Hanover, New Jersey, United States

Site Status RECRUITING

University of Washington

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Erica Weber

Role: CONTACT

973-324-8451

Facility Contacts

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Abby Welch

Role: primary

303-789-8039

Sean Wallace

Role: primary

973-324-8441

Rebeca Costa

Role: backup

Aaron Flaster

Role: primary

206-616-7934

Other Identifiers

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R-1210-23

Identifier Type: -

Identifier Source: org_study_id

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