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

Brain Injuries, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169647
• Other study ID #: R-936-16
• Status: Completed
• Phase: N/A
• Start date: August 17, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2019
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Behavioral:
• Listening-based intervention
Participants will listen to pre-specified material on a CD

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 weeks