Metacognition in Neurological Injury

Brain Injuries Clinical Trial

Official title:

Longitudinal Examination of Metacognition in Neurological Samples

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03752697
• Other study ID #: 18123
• Status: Recruiting
• Start date: December 13, 2018
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: University of Nebraska Lincoln
• Contact: Kathy Chiou, Ph.D.
• Phone: 402-472-5843
• Email: kchiou2[@]unl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the trajectory of metacognitive functioning throughout phases of recovery from neurological insult, and to determine its relationship to rehabilitation compliance and functional outcome. It is hypothesized that metacognitive accuracy improves over time, and is a significant predictor of engagement in rehabilitation activities.

Description:

This study will examine the trajectory of metacognitive functioning through different phases of recovery from neurological insult, and document its relationship to rehabilitation compliance. Individuals currently completing rehabilitation programs and individuals from the community who meet study criteria are invited to participate. After consenting and enrolling in the study, participants complete 2 study sessions: a baseline session, and a follow-up session either at time of completion of rehabilitation program or 3 months later if not in a rehabilitation program. During the study sessions, participants will complete paper-and-pencil and computerized tests of cognition (including metacognitive tasks).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• history of brain and/or spinal cord injury
• no history of brain or neurological injury/insult (for healthy control group)
• fluent in spoken and written English
• adequate gross motor abilities to provide a button push on a keyboard

Exclusion Criteria:

• exclusion criteria for healthy controls include:
• current/past history of psychiatric illness
• learning disorder
• developmental disorder
• diagnosis of Attention Deficit Disorder/Attention Deficit Hyperactive Disorder

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Behavioral:
• metacognitive performance
Paper and pencil/computerized tests of metacognition

Locations

Country	Name	City	State
United States	University of Nebraska-Lincoln	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska Lincoln	Quality Living, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline metamemory performance to completion of rehabilitation	The computerized metamemory test produces scores that are used to calculate a gamma coefficient, which is a quantitative measure of the individual's metacognitive performance/accuracy.	At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
Secondary	Change in rehabilitative engagement	The rehabilitative engagement questionnaire is a clinician-report measure that queries the clinician's perception of their client's participation in rehabilitation services.	At baseline and at end of length of stay in rehabilitative setting (on average 3 months)