- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05009511
MRI Markers of Feedback Timing During Learning in Individuals With TBI With and Without Clinical Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overall objective of the proposed project is to investigate brain mechanisms during learning in individuals with traumatic brain injury (TBI) with and without clinical depression. Such knowledge can help guide rehabilitation strategies and reduce the burden of TBI. Feedback about the accuracy of one's actions can improve learning by informing an individual whether his/her action is correct or not. Individuals with depression have been shown to have learning deficits and altered brain activity during learning compared to healthy individuals when feedback is presented immediately. Impaired learning through immediate feedback has also been observed in Parkinson's disease (PD) patients. However, PD patients are able to learn from feedback when it is presented after a delay, engaging separate neural mechanisms. Individuals with TBI have also been shown to have learning deficits that are likely exacerbated by depressive symptoms. However, there is no evidence directly examining the neural mechanisms of learning in individuals with TBI with and without depression. The proposed research explores this distinction.
The elucidation of the neural mechanisms associated with learning in individuals with TBI with and without clinical depression will inform 1) scientific knowledge about the effect of depression on the injured brain, 2) TBI interventions about the effectiveness of feedback and its timing, and 3) interventions for other clinical populations that require rehabilitation and have high occurrence of depression. These objectives lie at the heart of the mission of the National Institute of Neurological Disorders and Stroke as they will broaden "fundamental knowledge about the brain and nervous system" associated with learning in TBI and the knowledge gained from fulfilling the above objectives will "reduce the burden" of learning deficits after TBI.
To test these hypotheses, participants will be recruited based on structured clinical interview performed by the team member trained in psychiatric interviewing. Qualified participants will perform an experiment during which they will first study word pairs outside of the functional magnetic resonance imaging scanner. Then, in the scanner, participants will see word pairs again in a multiple-choice format and will have to choose a match for each word. After participants make their choice, feedback will be presented either immediately or after a delay of 25 minutes. The experiment will end with the Test phase, which takes place outside of the scanner, where participants will be presented with the words in the multiple-choice format again so the influence of each feedback type on learning can be evaluated.
Investigators hypothesize that depressed individuals with and without TBI will learn better from delayed compared to immediate feedback, because learning through delayed feedback relies on a different neural mechanism, which is not affected by depression and TBI, compared to learning through immediate feedback. Non-depressed individuals without TBI and clinically depressed individuals without TBI will also be recruited to delineate the influences of depression from the impact of TBI on the brain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julia McMillan, BA
- Phone Number: 973-323-3684
- Email: jmcmillan@kesslerfoundation.org
Study Contact Backup
- Name: Belinda Washington, BA
- Phone Number: 973-324-8446
- Email: bwashington@kesslerfoundation.org
Study Locations
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New Jersey
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West Orange, New Jersey, United States, 07052
- Recruiting
- Kessler Foundation
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Contact:
- Belinda L Washington, BA
- Phone Number: 973-324-8446
- Email: bwashington@kesslerfoundation.org
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Principal Investigator:
- Ekaterina Dobryakova, PhD
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Contact:
- Kai Sucich, MA
- Phone Number: 973-323-3693
- Email: ksucich@kesslerfoundation.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- I am between the ages of 18 and 65.
- I have been diagnosed with a TBI.
- I am an individual without TBI.
- I am right-handed.
- I have normal vision or corrected to normal vision.
- I can read and speak English fluently.
- I do or do not have a current diagnosis of Depression.
- I am not currently pregnant.
Exclusion Criteria:
- I have had a neurological disease, other than TBI.
- I have a significant history of alcohol or drug abuse as determined by study staff.
- I have metal in my body (shrapnel, piercing that cannot be taken off, retainer on the upper jaw).
- I have something in my body that restricts me from having an MRI such as: an aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant (internal hearing aids); ocular foreign body (e.g. metal shavings in my eye), insulin pump or any pre- existing eye conditions (such as blurry vision, seeing double, and abnormal eye movements).
- I experience discomfort in closed spaces (claustrophobia).
- I have been diagnosed with a neurologic illness such as epilepsy, brain tumors, etc. (e.g. schizophrenia and bipolar disorder).
- I have had corticosteroid treatment less than a month ago as determined by study staff review of my medications.
- I have been informed by my doctor that is it unsafe for me to receive regular MRI as part of my medical care.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Traumatic Brain Injury (TBI)
Individuals with moderate-to-severe injury severity, defined as post-traumatic amnesia lasting more than 24hrs, loss of consciousness lasting more than 30 min, Glasgow Coma Scale (GCS) score less than 13.
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The goal of this investigation is to examine the influence of feedback timing on learning and brain function.
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Experimental: Traumatic Brain Injury (TBI) with MDD
Individuals with moderate-to-severe injury severity, defined as post-traumatic amnesia lasting more than 24hrs, loss of consciousness lasting more than 30 min, Glasgow Coma Scale (GCS) score less than 13.
In addition, individuals will have a diagnosis of major depressive disorder (MDD) as per DSM-5.
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The goal of this investigation is to examine the influence of feedback timing on learning and brain function.
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Experimental: Major Depressive Disorder (MDD)
Individuals meeting criteria for major depressive disorder (MDD) including qualifiers 'in partial remission' or 'in full remission' if they are actively in treatment for the condition and still carry the depression diagnosis.
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The goal of this investigation is to examine the influence of feedback timing on learning and brain function.
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Experimental: Healthy Individuals
Healthy individuals without psychiatric and neurological conditions.
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The goal of this investigation is to examine the influence of feedback timing on learning and brain function.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Learning accuracy
Time Frame: Collected during the single 1 day study
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Participants' learning accuracy (in percent) assessed with Eprime software
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Collected during the single 1 day study
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functional MRI
Time Frame: Collected during the single 1 day study
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Participants brain activity
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Collected during the single 1 day study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verbal Paired Associates test
Time Frame: Collected during the single 1 day study
|
Verbal learning and memory assessment
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Collected during the single 1 day study
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Logical Memory test
Time Frame: Collected during the single 1 day study
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Verbal learning and memory assessment
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Collected during the single 1 day study
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Delis-Kaplan Executive Function System
Time Frame: Collected during the single 1 day study
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Executive functioning assessment
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Collected during the single 1 day study
|
Test of Premorbid Functioning
Time Frame: Collected during the single 1 day study
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Pre-morbid cognitive and memory functioning assessment
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Collected during the single 1 day study
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Ruff 2 & 7 Selective Attention Test
Time Frame: Collected during the single 1 day study
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Attention Assessment
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Collected during the single 1 day study
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Wechsler Adult Intelligence Scale, 4th edition
Time Frame: Collected during the single 1 day study
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Working memory/processing assessment
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Collected during the single 1 day study
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Behavioral Inhibition/Behavioral Approach Scale
Time Frame: Collected during the single 1 day study
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Questionnaire
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Collected during the single 1 day study
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GAD
Time Frame: Collected during the single 1 day study
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Questionnaire
|
Collected during the single 1 day study
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PCL
Time Frame: Collected during the single 1 day study
|
Questionnaire
|
Collected during the single 1 day study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ekaterina Dobryakova, PhD, Kessler Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-1142-21
- R01NS121107 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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