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

October 21, 2019 updated by: Kessler Foundation
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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
listening-based protocol (type A)
Participants will listen to pre-specified material on a CD
Placebo Comparator: Control
listening-based protocol (type B)
Participants will listen to pre-specified material on a CD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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