Examining how feedback timing affects learning in individuals with traumatic brain injury and depression
MRI Markers of Feedback Timing During Learning in Individuals with TBI with and Without Clinical Depression
This study is testing how the timing of feedback affects learning in people with moderate-to-severe traumatic brain injury and depression to see if it can help improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT05009511 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of feedback timing on learning and brain function in individuals with moderate-to-severe traumatic brain injury (TBI), both with and without clinical depression. By utilizing fMRI, the research aims to uncover the neural mechanisms involved in learning processes affected by TBI and depression. The study will compare learning outcomes based on immediate versus delayed feedback, providing insights that could inform rehabilitation strategies for TBI patients. The findings may also have implications for other clinical populations facing similar challenges in learning and memory.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 65 who have been diagnosed with a traumatic brain injury, with or without a current diagnosis of depression.
Not a fit: Patients with neurological diseases other than TBI or those with significant histories of substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for individuals with TBI and depression, enhancing their learning capabilities.
How similar studies have performed: While studies have explored learning deficits in other populations, this specific investigation into TBI and depression is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Ekaterina Dobryakova, PHD — Kessler Foundation
- Study coordinator: Julia McMillan, BA
- Email: jmcmillan@kesslerfoundation.org
- Phone: 973-323-3684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.