Traumatic Brain InjuryNCT05009511
MRI Markers of Feedback Timing During Learning in Individuals with TBI with and Without Clinical Depression
A study testing Learning through feedback in people with Traumatic Brain Injury and Major Depressive Disorder, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Major Depressive Disorder
- What is being tested?
- Learning through feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Kai Sucich, MA, 973-323-3693, ksucich@kesslerfoundation.org
Belinda L Washington, BA, 973-324-8446, bwashington@kesslerfoundation.org
About this study
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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Major Depressive Disorder
- Being tested
- Learning through feedback
- Keywords
- fMRI, Traumatic Brain Injury, Major Depressive Disorder, Learning, Memory, Feedback, Rehabilitation
- Medical subject headings
- Brain Injuries, Traumatic, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning through feedbackBehavioural
The goal of this investigation is to examine the influence of feedback timing on learning and brain function.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Learning through feedback |
| Healthy Individuals | Experimental | Healthy individuals without psychiatric and neurological conditions. Receives: Behavioral: Learning through feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning accuracy
Participants' learning accuracy (in percent) assessed with Eprime software
Measured: Collected during the single 1 day study
functional MRI
Participants brain activity
Measured: Collected during the single 1 day study
Secondary outcomes (9)
Verbal Paired Associates test
Verbal learning and memory assessment
Measured: Collected during the single 1 day study
Logical Memory test
Verbal learning and memory assessment
Measured: Collected during the single 1 day study
Delis-Kaplan Executive Function System
Executive functioning assessment
Measured: Collected during the single 1 day study
Test of Premorbid Functioning
Pre-morbid cognitive and memory functioning assessment
Measured: Collected during the single 1 day study
Ruff 2 & 7 Selective Attention Test
Attention Assessment
Measured: Collected during the single 1 day study
Wechsler Adult Intelligence Scale, 4th edition
Working memory/processing assessment
Measured: Collected during the single 1 day study
Behavioral Inhibition/Behavioral Approach Scale
Questionnaire
Measured: Collected during the single 1 day study
GAD
Questionnaire
Measured: Collected during the single 1 day study
PCL
Questionnaire
Measured: Collected during the single 1 day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Moss Rehabilitation Research Institute
- Responsible party
- Principal investigator, Ekaterina Dobryakova, Kessler Foundation
- Investigators
- Ekaterina Dobryakova, PHD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009511
- Sponsor's protocol ID
- R-1142-21
- Other IDs
- R01NS121107
- Status last verified
- Dec 2023
- First submitted
- 30 Jul 2021
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Markers of Feedback Timing During Learning in Individuals with TBI with and Without Clinical Depression
- ClinicalTrials.gov ID
- NCT05009511
- Acronym / sponsor ID
- R-1142-21
- Conditions
- Traumatic Brain Injury, Major Depressive Disorder
- Keywords
- fMRI, Traumatic Brain Injury, Major Depressive Disorder, Learning, Memory, Feedback, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Moss Rehabilitation Research Institute
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury (TBI) | Experimental | Behavioral: Learning through feedbackIndividuals 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. |
| Traumatic Brain Injury (TBI) with MDD | Experimental | Behavioral: Learning through feedbackIndividuals 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. |
| Major Depressive Disorder (MDD) | Experimental | Behavioral: Learning through feedbackIndividuals 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 | Experimental | Behavioral: Learning through feedbackHealthy individuals without psychiatric and neurological conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learning through feedbackThe goal of this investigation is to examine the influence of feedback timing on learning and brain function. | Behavioural | Healthy Individuals, Major Depressive Disorder (MDD), Traumatic Brain Injury (TBI), Traumatic Brain Injury (TBI) with MDD |
Primary outcome
Learning accuracy
Time frame: Collected during the single 1 day study
Participants' learning accuracy (in percent) assessed with Eprime software
functional MRI
Time frame: Collected during the single 1 day study
Participants brain activity
9 secondary outcomes
Verbal Paired Associates test
Time frame: Collected during the single 1 day study
Logical Memory test
Time frame: Collected during the single 1 day study
Delis-Kaplan Executive Function System
Time frame: Collected during the single 1 day study
Test of Premorbid Functioning
Time frame: Collected during the single 1 day study
Ruff 2 & 7 Selective Attention Test
Time frame: Collected during the single 1 day study
Wechsler Adult Intelligence Scale, 4th edition
Time frame: Collected during the single 1 day study
Behavioral Inhibition/Behavioral Approach Scale
Time frame: Collected during the single 1 day study
GAD
Time frame: Collected during the single 1 day study
PCL
Time frame: Collected during the single 1 day study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekaterina Dobryakova, PHD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning through feedback in people with Traumatic Brain Injury and Major Depressive Disorder, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia McMillan, BA (973-323-3684, jmcmillan@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning accuracy (time frame: Collected during the single 1 day study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.