NCT03169647

Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

Metacognition, in-the-moment awareness of performance while engaging in cognitive tasks, is negatively affected by traumatic brain injury (TBI). Metacognitive deficits can greatly reduce quality of life for individuals with TBI as functioning in this domain has been closely linked with successful independent living and community re-integration. Problematically, there are currently no empirically validated treatment options that address metacognitive deficits after TBI. Recent research in healthy samples demonstrates that specific listening interventions may alter neural activation in brain works associated with metacognition and can improve metacognitive functioning; however, it remains unknown if these effects generalize to individuals with TBI. Thus, the objective of the proposed study is to use a double-blind, placebo controlled randomized clinical trial to determine the efficacy of applying a specific listening intervention to improve metacognition after TBI and to employ functional magnetic resonance imaging (fMRI) to document the neural mechanisms by which the intervention operates.

Conditions

• Brain Injuries, Traumatic

Interventions

Type	Name	Description
BEHAVIORAL	Listening-based intervention	Participants will listen to pre-specified material on a CD

Timeline

• Start date: 2017-08-17
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2017-05-30
• Last updated: 2019-10-23

Locations

1 site across 1 country: United States