Learning through feedback for Traumatic Brain Injury (TBI)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kessler Foundation, West Orange, NJ
Traumatic Brain Injury (TBI)+6 More
Learning through feedback - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

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

See full description

Eligible Conditions

  • Traumatic Brain Injury (TBI)
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Learning through feedback will improve 2 primary outcomes and 9 secondary outcomes in patients with Traumatic Brain Injury (TBI). Measurement will happen over the course of Collected during the single 1 day study.

Day 1
Behavioral Inhibition/Behavioral Approach Scale
Delis-Kaplan Executive Function System
GAD
Learning accuracy
Logical Memory test
PCL
Ruff 2 & 7 Selective Attention Test
Test of Premorbid Functioning
Verbal Paired Associates test
Wechsler Adult Intelligence Scale, 4th edition
functional MRI

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

Traumatic Brain Injury (TBI)
1 of 4
Major Depressive Disorder (MDD)
1 of 4
Healthy Individuals
1 of 4
Traumatic Brain Injury (TBI) with MDD
1 of 4
Experimental Treatment

This trial requires 180 total participants across 4 different treatment groups

This trial involves 4 different treatments. Learning Through Feedback is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Traumatic Brain Injury (TBI)
Behavioral
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.
Major Depressive Disorder (MDD)
Behavioral
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.
Healthy Individuals
Behavioral
Healthy individuals without psychiatric and neurological conditions.
Traumatic Brain Injury (TBI) with MDD
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: collected during the single 1 day study
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly collected during the single 1 day study for reporting.

Who is running the study

Principal Investigator
E. D.
Ekaterina Dobryakova, Principal Investigator
Kessler Foundation

Closest Location

Kessler Foundation - West Orange, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

What are the common side effects of learning through feedback?

"In this group of students, learning through feedback was not detrimental to cognitive or academic performance, contrary to some previous reviews. There was little evidence of the effects of this specific method of instruction. Longer-term studies are needed to determine the potential of learning through feedback in both educational and other settings." - Anonymous Online Contributor

Unverified Answer

What are the signs of brain injuries?

"The findings of the current study support the importance of considering not only the history, but also the physical appearance and neurological findings during the assessment of patients with head injuries." - Anonymous Online Contributor

Unverified Answer

How many people get brain injuries a year in the United States?

"Approximately 80,000 people a year (10.7/10,000) become injured at the level of the cranial vault such as the brain, face, or skull. Patients who become injured are most often injured by falls from a height, by collisions with objects, and by assaults and assaults with blunt instruments. In a population of people with head trauma, 12% will have an intracranial bleed. The clinical manifestations of intracranial hemorrhage are almost always fatal. The most common intracranial injury seen in emergency departments is a basilar skull fracture (about 44% of intracranial injuries)." - Anonymous Online Contributor

Unverified Answer

What causes brain injuries?

"There is a wide spectrum of brain injuries that could have multiple contributing causes. The causes of brain injuries are commonly categorized into traumatic brain injuries, cerebral ischemic damage, and cerebrovascular damage, but there are some diseases, neurological syndromes, and genetic disorders that also affect brain function and health. What causes brain injuries in newborns and children? answer: Childhood brain injuries, in particular traumatic cerebral lesions and cerebral metabolic disorders, are frequently underrecognized." - Anonymous Online Contributor

Unverified Answer

Can brain injuries be cured?

"[There are three kinds of mental illnesses that have been identified as curable: depression, anxiety disorders, and psychosis: schizophrenia.] While some mental illnesses have been curable in the past, the criteria for curability have evolved, and the current state of research on mental illness is more likely to be focused on identifying the best methods of treatment." - Anonymous Online Contributor

Unverified Answer

What is brain injuries?

"Brain injuries are injuries to the brain, commonly caused by trauma, ischemic insult, hemorrhage, hypoxia, or infection. Tumors and infections of the brain and cerebrospinal fluid can occur. They can be life threatening or only impede activity. They cause significant disability." - Anonymous Online Contributor

Unverified Answer

What are common treatments for brain injuries?

"These common treatments for brain injuries include surgical procedures for brain abscess, decompression of aneurysms, removal of hemorrhage, decompression of a subarachnoid hematoma, and shunt surgery for hydrocephalus. Treatment also may involve the insertion of intrathecal or intracerebroventricular catheters. The choice of treatment depends partly on the severity of the condition and partly on what the individual has wanted to do and how he or she feels about the issue. Also, the goal of the treatment often is in part to maintain a normal life for as much as possible." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for brain injuries?

"The majority of people with a brain injury are considering clinical trials of new treatments. However, even with the availability of the best evidence, most people are not actively seeking clinical trials for their brain injury. More comprehensive clinical trials might help to identify some treatments that are most likely to be effective." - Anonymous Online Contributor

Unverified Answer

Is learning through feedback typically used in combination with any other treatments?

"Learning through feedback may sometimes be added to neuropsychotherapy but is not necessarily included as a treatment modality in itself. Results from a recent paper, there was no statistically significant difference between patients who received neuropsychotherapy with (1) no learning through feedback, (2) learning through feedback at first session, (3) learning through feedback early in treatment, and (4) learning through feedback at the whole treatment session (mean pre-post-treatment score for group 4 was significantly lower than for group 3 [t-test, p = 0.010]. The difference for group 4 was not significant during post-hoc statistical analysis)." - Anonymous Online Contributor

Unverified Answer

What is learning through feedback?

"This article describes how the use of feedback can be used as a tool to improve both motor control and learning. For all to utilize efficiently, there must be motivation on the part of those who receive feedback, as well as the right skill set to receive feedback. Further research needs to be conducted on how best to apply feedback to the learning of motor skills by children, and whether utilizing such feedback could improve learning, as well as how the application of such feedback can be effective in motor skill learning." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving learning through feedback?

"Other research has focused on learning, which involves a variety of approaches, among which the use of feedback (whether it is in the form of summative feedback or in the form of automated feedback and/or computer-assisted feedback) is currently under investigation. Some of this work has focused on learning through feedback in neurologically impaired or disabled patients, and some on learning in rehabilitation and in the workplace. The use of a human error monitor seems particularly suited to detecting subtle performance errors. There is considerable evidence that computer-assisted feedback is an effective method of providing feedback to assist people in learning/recovering (e.g. Parkinson's disease, stroke, etc.)." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in learning through feedback for therapeutic use?

"Results from a recent paper of the current review show that a learning by feedback strategy is effective in enhancing and speeding up knowledge of therapeutic skills for use in the clinical practice, and the application of this approach can bring advantages for patients. This kind of learning by feedback is feasible and useful for learning and applying physical and theoretical skills in clinical practice, and in the assessment of the performance of physical and intellectual skills and their relation with one another." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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