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

NCT05009511 | Unknown

• 2 other identifiers: R-1142-21R01NS121107
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Major Depressive Disorder

Keywords

fMRI; Traumatic Brain Injury; Major Depressive Disorder; Learning; Memory; Feedback; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Learning accuracy

  Participants' learning accuracy (in percent) assessed with Eprime software

  Collected during the single 1 day study

• functional MRI

  Participants brain activity

  Collected during the single 1 day study

Secondary Outcomes (9)

• Verbal Paired Associates test

  Collected during the single 1 day study

• Logical Memory test

  Collected during the single 1 day study

• Delis-Kaplan Executive Function System

  Collected during the single 1 day study

• Test of Premorbid Functioning

  Collected during the single 1 day study

• Ruff 2 & 7 Selective Attention Test

  Collected during the single 1 day study

Study Arms (4)

Traumatic Brain Injury (TBI)

EXPERIMENTAL

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.

Behavioral: Learning through feedback

Traumatic Brain Injury (TBI) with MDD

EXPERIMENTAL

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.

Behavioral: Learning through feedback

Major Depressive Disorder (MDD)

EXPERIMENTAL

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.

Behavioral: Learning through feedback

Healthy Individuals

EXPERIMENTAL

Healthy individuals without psychiatric and neurological conditions.

Behavioral: Learning through feedback

Interventions

Learning through feedback BEHAVIORAL

The goal of this investigation is to examine the influence of feedback timing on learning and brain function.

Healthy Individuals; Major Depressive Disorder (MDD); Traumatic Brain Injury (TBI); Traumatic Brain Injury (TBI) with MDD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Moss Rehabilitation Research Institute: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ekaterina Dobryakova, PHD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia McMillan, BA

CONTACT

973-323-3684; jmcmillan@kesslerfoundation.org

Belinda Washington, BA

CONTACT

973-324-8446; bwashington@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 17, 2021
• Study Start: September 1, 2021
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: October 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)