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 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.

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Key information

Conditions

Brain Injuries, Traumatic Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

diagnosis of moderate or severe brain injury
between the ages of 18 and 59.
able to read and speak English fluently.
TBI at least 1 year ago.

Exclusion criteria

pregnant.
left-handed.
color-blind.
diagnosed with significant psychiatric illness (e.g., bipolar, schizophrenia).
receiving or have received inpatient and/or rehabilitative treatment for substance use.
diagnosis of a neurological condition other than TBI (e.g., epilepsy, multiple sclerosis, stroke).
any metal in my body that has not been declared MRI-safe by my physician.
impaired independent use of either hand.
any of the following in/on my body that may interfere with MRI: pacemaker, implanted electrical devices, brain stimulators, particular types of dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
history of engaging in welding and/or metal working activities.
formal training or am a current practitioner of yoga, meditation, and/or mindfulness.
currently involved in any other type of thinking skills and/or emotional treatment, such as psychotherapy.

Treatment and study plan

Listening-based intervention

Behavioral

Participants will listen to pre-specified material on a CD

Primary outcomes

Goodman and Kruskal gamma coefficient on MRI-based metacognitive task

Time frame: 7 weeks

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 that is commonly used in the metacognitive literature.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: May 30, 2017
Registry last updated: Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed