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

NCT03169647 | Completed

• 1 other identifier: R-936-16
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

listening-based protocol (type A)

Behavioral: Listening-based intervention

Control

PLACEBO COMPARATOR

listening-based protocol (type B)

Behavioral: Listening-based intervention

Interventions

Listening-based intervention BEHAVIORAL

Participants will listen to pre-specified material on a CD

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: May 30, 2017
• Study Start: August 17, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)