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Trial record 4 of 319 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

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ClinicalTrials.gov Identifier: NCT03169647
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

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.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Behavioral: Listening-based intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury
Estimated Study Start Date : August 17, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
listening-based protocol (type A)
Behavioral: Listening-based intervention
Participants will listen to pre-specified material on a CD

Placebo Comparator: Control
listening-based protocol (type B)
Behavioral: Listening-based intervention
Participants will listen to pre-specified material on a CD




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169647


Contacts
Contact: Erica Weber, PhD 973-324-8451 eweber@kesslerfoundation.org
Contact: Nancy Chiaravalloti, PhD nchiaravalloti@kesslerfoundation.org

Locations
United States, New Jersey
Kessler Foundation Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Erica Weber, PhD    973-324-8451    eweber@kesslerfoundation.org   
Principal Investigator: Erica Weber, PhD         
Sponsors and Collaborators
Kessler Foundation

Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT03169647     History of Changes
Other Study ID Numbers: R-936-16
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System