Clinical trial NCT03169647: 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
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Goodman and Kruskal gamma coefficient on MRI-based metacognitive task
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: