RT fMRI for Traumatic Brain Injury (TBI)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Carl R Darnall Army Medical Center (CRDAMC), Fort Hood, TX
Traumatic Brain Injury (TBI)+5 More
RT fMRI - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a brain training program or computer-based cognitive training can improve cognitive function in people with brain injury.

See full description

Eligible Conditions

  • Traumatic Brain Injury (TBI)
  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether RT fMRI will improve 1 primary outcome and 4 secondary outcomes in patients with Traumatic Brain Injury (TBI). Measurement will happen over the course of 8 weeks.

4 and 8 weeks
Exercise Based Assessments
8 weeks
Functional Assessments
Neuropsychological assessments
Participant-reported outcomes
Working/School Status

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Ctrl RT fMRI/Exp Cognitive Training
1 of 4
Exp RT fMRI/Exp Cognitive Training
1 of 4
Exp RT fMRI/Ctrl Cognitive training
1 of 4
Ctr RT fMRI/Ctr Cognitive Training
1 of 4
Experimental Treatment
Non-Treatment Group

This trial requires 150 total participants across 4 different treatment groups

This trial involves 4 different treatments. RT FMRI is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Ctrl RT fMRI/Exp Cognitive TrainingControl RT fMRI (real-time functional MRI) and experimental cognitive training.
Exp RT fMRI/Exp Cognitive TrainingBoth experimental conditions.
Exp RT fMRI/Ctrl Cognitive trainingExperimental real-time fMRI and control cognitive training.
Ctr RT fMRI/Ctr Cognitive TrainingControl real-time fMRI and control cognitive training.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Training
2008
Completed Phase 3
~4100

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 and 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 and 8 weeks for reporting.

Closest Location

Carl R Darnall Army Medical Center (CRDAMC) - Fort Hood, TX

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Mild TBI: PTA/confusion≤1 hour immediately after injury; or LOC <30 min [69] confirmed by the Ohio confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF).
Age 18-45 years
Right handed [70].
Minimum of 4 months and within 36 months post-injury
Can participate in fMRI and outcome assessment
Adequate visual, auditory, sensory-motor function for training program.
Fluent in English
Persistent cognitive dysfunction confirmed by an objective measure

Patient Q&A Section

What causes brain injuries?

"Brain injuries may be due to different types of trauma including accidents, blunt force and penetrating injuries and to other circumstances such as stroke and infectious, congenital or degenerative diseases. Damage to brain tissue is caused by changes to the cells that function in the brain. Damage to white matter can be caused by direct injury, e.g. penetrating trauma, or damage can be caused by changes to the blood supply to the brain, or by the breakdown of the blood–brain barrier. Changes to the blood supply can produce changes in the level of nutrients and removal of waste products. Damage to the cerebellum is often associated with ataxia but can result in other abnormalities such as hemiparesis and alexia." - Anonymous Online Contributor

Unverified Answer

Can brain injuries be cured?

"Bones or other surgically inserted implants may be the cause of many cases of chronic brain pain in young people. These brain injuries may be surgically repaired but there is no evidence that the results of the repairs can be long-term pain relief." - Anonymous Online Contributor

Unverified Answer

What is brain injuries?

"The brain experiences the full impact of traumatic brain injury and is frequently a cause of permanent disabilities for individuals with multiple injuries in the process. The brain damage can arise from various causes, both natural and manmade, and can have a number of effects when it occurs.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of brain injuries?

"The symptoms of brain injury should be considered, as a person may have symptoms such as visual field defects, an altered level of consciousness, amnesia, difficulty swallowing or talking and problems with concentration." - Anonymous Online Contributor

Unverified Answer

What are common treatments for brain injuries?

"There is no one cure for brain injuries. Brain injuries may need long-term treatment and can cause severe, debilitating or fatal complications. Commonly, treatment is supportive. Behavioral and cognitive therapies may help patients to maintain their skills and return to the normal activities. Neuroprotectants and neuroenhancers are useful to restore function after brain injuries. Surgery is often important in the management of brain injury but the outcome is dependent on the cause, extent and prognosis of brain injury." - Anonymous Online Contributor

Unverified Answer

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

"About 2 million people get a [brain injury](https://www.withpower.com/clinical-trials/brain-injury) each year; about 14% of these individuals suffer life-threatening health problems. The National Highway Traffic Safety Administration (NHTSA) reported the number of pedestrians and bicyclists killed by traveling vehicles to be 78,070 and 31,000, respectively in 1998. The number of pedestrian deaths is more than doubled to about 135,000 per year that same period. Although the injury rate of pedestrians has declined since the mid-1960s and has declined more than the motorcycle mortality rate, pedestrian fatalities are still the leading cause of unintentional vehicular deaths. The majority of walking deaths are still caused by children younger than 25 years of age." - Anonymous Online Contributor

Unverified Answer

Is rt fmri safe for people?

"With rt fmri, participants do not have to be aware of the scanner or the scanner motion, and participants may not have to worry about overheating. Rt fmri can be used to screen for people at risk of brain injury, including in children and adolescents, those with recent stroke or severe brain injury, those in critical care, and those with focal neurological signs to the brain or those with a history of seizures." - Anonymous Online Contributor

Unverified Answer

How serious can brain injuries be?

"We found that although head injury patients with more severe injury, longer hospital stay and major disability are older and have worse outcomes than those with less serious injury, they still have good long-lasting functional outcomes on average." - Anonymous Online Contributor

Unverified Answer

Does rt fmri improve quality of life for those with brain injuries?

"We found that fMRI is efficient for assessing quality of life in patients with brain injuries. It is also able to provide additional information when the EQ-5D-5L fails." - Anonymous Online Contributor

Unverified Answer

Does brain injuries run in families?

"Results from a recent clinical trial suggest that a genetic factor in the brain is important for the development of brain injuries, but that an environmental factor (such as alcohol) may be important in a small fraction of cases. However, more research is needed to investigate the biological or genetic factor underpinning brain injury." - Anonymous Online Contributor

Unverified Answer

What is the latest research for brain injuries?

"In summary, current research can not fully explain the cause of brain injuries and therefore cannot provide a satisfactory explanation of their treatment. Since research is continually improving, the current field of research is a good one to follow. However, we would advise that the readers of the literature should be vigilant to recognize the methodological limitations within the field. Clinicians should be aware of research developments to remain up to date and incorporate them in their treatment plans." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of brain injuries?

"Multiple causes of brain injuries contribute to the overall burden of this disabling condition. For many years, the underlying etiology of brain injuries has not been fully elucidated. In this review, we discuss the current research that contributes to our understanding of the many factors that can lead to brain injuries." - 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.
See if you qualify for this trial
Get access to this novel treatment for Traumatic Brain Injury (TBI) by sharing your contact details with the study coordinator.