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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 collected during the single 1 day study
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below

Exclusion 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.
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I have been diagnosed with a neurological condition like epilepsy or bipolar disorder.

Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~collected during the single 1 day study
This trial's timeline: 1 day for screening, Varies for treatment, and collected during the single 1 day study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Learning accuracy
functional MRI
Secondary outcome measures
Behavioral Inhibition/Behavioral Approach Scale
Delis-Kaplan Executive Function System
GAD
+6 more

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
172 Previous Clinical Trials
10,483 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,337 Previous Clinical Trials
648,664 Total Patients Enrolled
Moss Rehabilitation Research InstituteOTHER
10 Previous Clinical Trials
9,724 Total Patients Enrolled

Media Library

Learning through feedback (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05009511 — N/A
Traumatic Brain Injury Research Study Groups: Major Depressive Disorder (MDD), Traumatic Brain Injury (TBI) with MDD, Healthy Individuals, Traumatic Brain Injury (TBI)
Traumatic Brain Injury Clinical Trial 2023: Learning through feedback Highlights & Side Effects. Trial Name: NCT05009511 — N/A
Learning through feedback (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05009511 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate goal of this medical research endeavor?

"The primary aim of this one-day study, which will be evaluated via functional MRI scans, is to record patient data. Secondary goals include the assessment of pre-morbid cognitive and memory functioning through GAD questionnaires and Behavioral Inhibition/Behavioral Approach Scale measurements."

Answered by AI

What is the sample size of participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical study launched on September 1st 2021 and is still actively recruiting patients. 180 volunteers need to be sourced from a single centre for the trial's completion."

Answered by AI

Could I be included in this research effort?

"This clinical trial is seeking 180 volunteers aged 18-65 with a traumatic brain injury (TBI) diagnosis. To be eligible, participants must also possess the following characteristics: age between 18 and 65; no TBI diagnosis; right-handedness; normal or corrected vision; English fluency; depression status (with/without); non-pregnant status."

Answered by AI

Is this study seeking volunteers who are 45 years of age or older?

"This clinical trial is only open to participants aged 18-65. There are separate trials available for those younger and older, respectively with 252 studies targeting patients under the age of eighteen, and 1183 related to individuals over 65 years old."

Answered by AI

Are there any opportunities for participants to join this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that the trial, originally published on September 1st 2021, is actively enrolling participants now. Approximately 180 people are sought for this research at a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Kessler Foundation
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Get treatment and get compensated. Very interested in new tx. As I’ve suffered from depression since my teens am now 66 years old.
PatientReceived no prior treatments
I suffer with major depressive disorder PTSD and adjustment disorder and hoping to find relief from these conditions.
PatientReceived 1 prior treatment
I lost my health insurance and I'm not sure it's worth it. and have been off my Lexapro for about 6 months. I have insurance now but seeing a doctor is extremely expensive.
PatientReceived 2+ prior treatments
Ive been on multiple medications for over 40 years with limited results . Since being hospitalized for covid in 2020 ive been diagnosed with long covid do do memory, fatigue, depression/anxiety,fog and placed on disability since October 2022.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Kessler Foundation: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
~76 spots leftby Jan 2026