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Behavioral Intervention
Feedback Timing During Learning for TBI with Depression
Verified Trial
N/A
Recruiting
Led By Ekaterina Dobryakova, PHD
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fluent in English
Not currently pregnant
Must not have
Diagnosis of a neurological disease other than TBI
Diagnosis of neurologic illness such as epilepsy, brain tumors, schizophrenia, and bipolar disorder
Timeline
Screening 1 day
Treatment Varies
Follow Up 0 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how different feedback timing affects learning and brain function in people with TBI, with and without depression.
Who is the study for?
This trial is for English-speaking, right-handed adults aged 18-65 with traumatic brain injury (TBI), with or without depression. They must have normal or corrected-to-normal vision and not be pregnant. Excluded are those with other neurological diseases, substance abuse history, metal in the body, MRI restrictions, claustrophobia, recent corticosteroid treatment, or conditions like epilepsy.
What is being tested?
The study investigates how feedback timing affects learning and brain function in individuals with TBI. It specifically looks at differences between those who have depression and those who do not when receiving learning feedback.
What are the potential side effects?
Since this trial involves learning tasks and MRI scans rather than medication or invasive procedures, side effects are minimal but may include discomfort from staying still during the MRI and potential stress from cognitive tasks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a neurological condition that is not a traumatic brain injury.
Select...
I have been diagnosed with a neurological condition like epilepsy or bipolar disorder.
Timeline
Screening ~ 1 day0 visits
Treatment ~ Varies
Follow Up ~ 0 days0 visits
Screening ~ 1 day
Treatment ~ Varies
Follow Up ~0 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Learning accuracy
functional MRI
Secondary study objectives
Behavioral Inhibition/Behavioral Approach Scale
Delis-Kaplan Executive Function System
GAD
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Traumatic Brain Injury (TBI) with MDDExperimental Treatment1 Intervention
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.
Group II: Traumatic Brain Injury (TBI)Experimental Treatment1 Intervention
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.
Group III: Major Depressive Disorder (MDD)Experimental Treatment1 Intervention
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.
Group IV: Healthy IndividualsExperimental Treatment1 Intervention
Healthy individuals without psychiatric and neurological conditions.
Find a Location
Who is running the clinical trial?
Kessler FoundationLead Sponsor
181 Previous Clinical Trials
10,899 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,377 Previous Clinical Trials
651,657 Total Patients Enrolled
Moss Rehabilitation Research InstituteOTHER
11 Previous Clinical Trials
9,926 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken corticosteroids in the past month.I do not have a traumatic brain injury (TBI).You have normal vision or wear glasses or contacts to correct your vision to normal.I have been diagnosed with a neurological condition that is not a traumatic brain injury.You primarily use your right hand for tasks.This criterion does not provide enough information to be rewritten. It's unclear whether it refers to a requirement or exclusion. Can you please provide more context or details?I am between 18 and 65 years old.This criterion does not appear to be relevant to a clinical trial exclusion criteria. Can you please provide more information or context for this criterion?You have regular vision or use glasses or contacts to correct your vision to regular.I am between 18 and 65 years old.I have been diagnosed with a traumatic brain injury.I have been diagnosed with a neurological condition like epilepsy or bipolar disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Major Depressive Disorder (MDD)
- Group 2: Traumatic Brain Injury (TBI)
- Group 3: Traumatic Brain Injury (TBI) with MDD
- Group 4: Healthy Individuals
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
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