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NCT03169647 · ClinicalTrials.gov registry record · NA
Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury
A NA study, sponsored by Kessler Foundation.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT03169647: Completed NA study, sponsored by Kessler Foundation.
NCT03169647 is a NA study that has completed, run by Kessler Foundation. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03169647, a NA study, has completed, sponsored by Kessler Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study 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.
Primary Outcome
While participants are in the scanner, they will perform a metamemory paradigm that involves the completion of 2 components per trial: 1) a memory task (a non-verbal recognition task), and 2) a metacognitive task that immediately follows completion of every recognition item. Accuracy of metacognitive functioning can be quantified using the Goodman and Kruskal gamma coefficient,16 a value between -1 and 1, indicating the discrepancy between the participant's judgment and objective performance tha
Interventions
- BEHAVIORAL Listening-based intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-08-17 |
| Est. Completion | 2019-06-30 |
| Phase | NA |
What the finished NCT03169647 record still lists
NCT03169647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Listening-based intervention is the first listed.
NCT03169647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03169647 about?
NCT03169647 is a clinical study titled "Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury". 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 in...
What is the current status of trial NCT03169647?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2017-08-17. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT03169647?
The interventions under investigation include: Listening-based intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03169647?
This trial is sponsored by Kessler Foundation, which has 104 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03169647's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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