Back to resultsEvaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury
Primary Purpose
Brain Injuries, Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Listening-based intervention
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injuries, Traumatic
Eligibility Criteria
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.
Sites / Locations
- Kessler Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
listening-based protocol (type A)
listening-based protocol (type B)
Outcomes
Primary Outcome Measures
Goodman and Kruskal gamma coefficient on MRI-based metacognitive task
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03169647
Brief Title
Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury
Official Title
Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 17, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
listening-based protocol (type A)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
listening-based protocol (type B)
Intervention Type
Behavioral
Intervention Name(s)
Listening-based intervention
Intervention Description
Participants will listen to pre-specified material on a CD
Primary Outcome Measure Information:
Title
Goodman and Kruskal gamma coefficient on MRI-based metacognitive task
Description
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.
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury
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