search
Back to results

MRI Markers of Feedback Timing During Learning in Individuals With TBI With and Without Clinical Depression

Primary Purpose

Traumatic Brain Injury, Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Learning through feedback
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Traumatic Brain Injury focused on measuring fMRI, Traumatic Brain Injury, Major Depressive Disorder, Learning, Memory, Feedback, Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Traumatic Brain Injury (TBI)

Traumatic Brain Injury (TBI) with MDD

Major Depressive Disorder (MDD)

Healthy Individuals

Arm Description

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.

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.

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.

Healthy individuals without psychiatric and neurological conditions.

Outcomes

Primary Outcome Measures

Learning accuracy
Participants' learning accuracy (in percent) assessed with Eprime software
functional MRI
Participants brain activity

Secondary Outcome Measures

Verbal Paired Associates test
Verbal learning and memory assessment
Logical Memory test
Verbal learning and memory assessment
Delis-Kaplan Executive Function System
Executive functioning assessment
Test of Premorbid Functioning
Pre-morbid cognitive and memory functioning assessment
Ruff 2 & 7 Selective Attention Test
Attention Assessment
Wechsler Adult Intelligence Scale, 4th edition
Working memory/processing assessment
Behavioral Inhibition/Behavioral Approach Scale
Questionnaire
GAD
Questionnaire
PCL
Questionnaire

Full Information

First Posted
July 30, 2021
Last Updated
October 6, 2023
Sponsor
Kessler Foundation
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Moss Rehabilitation Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05009511
Brief Title
MRI Markers of Feedback Timing During Learning in Individuals With TBI With and Without Clinical Depression
Official Title
MRI Markers of Feedback Timing During Learning in Individuals With TBI With and Without Clinical Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Moss Rehabilitation Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this proposal is to examine the influence of feedback timing on learning and brain function in individuals with moderate-to-severe traumatic brain injury (TBI), with and without depression.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Major Depressive Disorder
Keywords
fMRI, Traumatic Brain Injury, Major Depressive Disorder, Learning, Memory, Feedback, Rehabilitation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traumatic Brain Injury (TBI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Traumatic Brain Injury (TBI) with MDD
Arm Type
Experimental
Arm Description
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.
Arm Title
Major Depressive Disorder (MDD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Individuals
Arm Type
Experimental
Arm Description
Healthy individuals without psychiatric and neurological conditions.
Intervention Type
Behavioral
Intervention Name(s)
Learning through feedback
Intervention Description
The goal of this investigation is to examine the influence of feedback timing on learning and brain function.
Primary Outcome Measure Information:
Title
Learning accuracy
Description
Participants' learning accuracy (in percent) assessed with Eprime software
Time Frame
Collected during the single 1 day study
Title
functional MRI
Description
Participants brain activity
Time Frame
Collected during the single 1 day study
Secondary Outcome Measure Information:
Title
Verbal Paired Associates test
Description
Verbal learning and memory assessment
Time Frame
Collected during the single 1 day study
Title
Logical Memory test
Description
Verbal learning and memory assessment
Time Frame
Collected during the single 1 day study
Title
Delis-Kaplan Executive Function System
Description
Executive functioning assessment
Time Frame
Collected during the single 1 day study
Title
Test of Premorbid Functioning
Description
Pre-morbid cognitive and memory functioning assessment
Time Frame
Collected during the single 1 day study
Title
Ruff 2 & 7 Selective Attention Test
Description
Attention Assessment
Time Frame
Collected during the single 1 day study
Title
Wechsler Adult Intelligence Scale, 4th edition
Description
Working memory/processing assessment
Time Frame
Collected during the single 1 day study
Title
Behavioral Inhibition/Behavioral Approach Scale
Description
Questionnaire
Time Frame
Collected during the single 1 day study
Title
GAD
Description
Questionnaire
Time Frame
Collected during the single 1 day study
Title
PCL
Description
Questionnaire
Time Frame
Collected during the single 1 day study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia McMillan, BA
Phone
973-323-3684
Email
jmcmillan@kesslerfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Belinda Washington, BA
Phone
973-324-8446
Email
bwashington@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekaterina Dobryakova, PHD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana McMillian, BA
Phone
973-323-3684
Email
jmcmillian@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Belinda L Washington, BA
Phone
973-324-8446
Email
bwashington@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Ekaterina Dobryakova, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MRI Markers of Feedback Timing During Learning in Individuals With TBI With and Without Clinical Depression

We'll reach out to this number within 24 hrs