CLINICAL TRIAL

: Cognitive Support Technology (CST) for Brain Injuries

Recruiting · Any Age · All Sexes · Kent, OH

This study is evaluating whether a set of activities can improve cognitive and vocational skills for people with traumatic brain injury.

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About the trial for Brain Injuries

Eligible Conditions
Brain Injuries, Traumatic · Brain Injuries · Traumatic Brain Injury (TBI) · Wounds and Injuries

Treatment Groups

This trial involves 2 different treatments. : Cognitive Support Technology (CST) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
: Cognitive Support Technology (CST)
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
: Cognitive Support Technology (CST)
BEHAVIORAL

Eligibility

This trial is for patients born any sex of any age. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Enrolled in a degree program at two-year and four-year colleges or universities
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline (enrollment in study) and 1 year (study completion)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline (enrollment in study) and 1 year (study completion).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether : Cognitive Support Technology (CST) will improve 1 primary outcome and 10 secondary outcomes in patients with Brain Injuries. Measurement will happen over the course of Baseline (enrollment in study) and 1 year (study completion).

Change in Current Employment Status
BASELINE (ENROLLMENT IN STUDY) AND 1 YEAR (STUDY COMPLETION)
Three items on questionnaire including dichotomous employment question (e.g., are you employed?), if yes, number of hours employed and weekly earnings.
Change in Acceptance of disability
BASELINE (ENROLLMENT IN STUDY) AND 1 YEAR (STUDY COMPLETION)
Measured using the Acceptance of Disability Scale- Short Form There are 50 self-report items. Each item, provides a single score that ranges from 1 (low acceptance of disability) to 6 (high acceptance of disability). An overall acceptance of disability score is derived by summing all items, with 300 as the highest possible score. Low acceptance scores fall below 175, whereas high acceptance scores range from 176 to 300
Change in Satisfaction with Social Support
BASELINE (ENROLLMENT IN STUDY) AND 1 YEAR (STUDY COMPLETION)
Measured using single item 5-point Likert question on questionnaire
Change in Grade Point Average (GPA)
BASELINE (ENROLLMENT IN STUDY) AND 1 YEAR (STUDY COMPLETION)
Participant GPA
Change in Satisfaction with transportation access
BASELINE (ENROLLMENT IN STUDY) AND 1 YEAR (STUDY COMPLETION)
Measured using single item 5-point Likert question on questionnaire
Change in Quality of Life (QoL)
BASELINE (ENROLLMENT IN STUDY) AND 1 YEAR (STUDY COMPLETION)
Measured using the Quality of Life Scale There are 16 items scored on a seven-point Likert scale. The seven responses are "delighted" (7), "pleased" (6), "mostly satisfied" (5),"mixed" (4), "mostly dissatisfied" (3), "unhappy" (2),"terrible" (1).The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112 with higher scores representing a higher reported quality of life.
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Patient Q & A Section

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

What are common treatments for brain injuries?

A large proportion of individuals treated for a brain injury recover. The goal of treatment is to reduce symptoms and complications, particularly after injury, but there are no treatment-specific survival benefits. The treatment should be appropriate for a given patient's medical and psychological condition.

Anonymous Patient Answer

What causes brain injuries?

Brain injuries develop due to a combination of genetic, environmental, and neurological factors. The neurological and functional impairment related to brain injuries is complex and has a large influence on the quality of life, work, and social relationships of the injured individual.\n

Anonymous Patient Answer

What is brain injuries?

The brain is a complex organ surrounded by the skull that houses the cerebrum. It is lined with a thin coat of grey matter, or grey matter, which protects the brain and contains a wide range of cells responsible for transmitting nerve impulses and regulating body functions. The gray matter serves as the principal neural connections while the white matter is made up of delicate fibers, which do not have a nerve impulse carrying capacity. The brain can also be damaged by brain injuries or by tumors. Brain injuries can be severe and often cause long term problems. These injuries can occur as a result of traumatic brain injuries (TBI), stroke, birth injury, metabolic abnormalities and many other types of causes.

Anonymous Patient Answer

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

Brain injury is common and serious with many potential consequences. If the goal of the US National Institutes of Health is to reduce the burden of brain injury in the US then our findings emphasize the urgency of developing a national strategy for brain injury prevention in the US with a focus on primary and secondary prevention. The American Academy of Pediatrics Committee on Traumatic Brain Injury concluded in 2009 that research is needed to determine whether trauma can increase the risk of future brain injury, while brain trauma in childhood can increase likelihood of future issues. Brain injury is associated with significant loss of life and productivity.

Anonymous Patient Answer

Can brain injuries be cured?

Multiple methods of brain injury evaluation including imaging and evaluation for biochemical parameters may be useful for long-term management of brain injury. In the future, it is hoped that innovative biologic therapeutic approaches will be developed for brain injury.

Anonymous Patient Answer

What are the signs of brain injuries?

Signs and symptoms will be more pronounced with a head injury versus a concussive injury. The severity of concussion is graded based on the Glasgow Coma Scale (GCS) score at the time of arrival. Patients with a GCS score greater than 12 will be more likely to recover from a mild head injury, which means a more severe injury. In patients with a GCS score between 9 and 12, the injury is usually non-severe and can almost always be safely treated at the scene by first responders. Patients with a GCS score under 9 will likely go on to develop clinical signs and symptoms of brain injuries and are at an exceptionally high risk for permanent brain damage and mortality.

Anonymous Patient Answer

What is the primary cause of brain injuries?

There are several well established risk factors for brain injuries; a detailed history of these conditions is critical during clinical evaluation and in the diagnosis of brain injuries. A diagnosis in the medical record of a potential [traumatic brain injury](https://www.withpower.com/clinical-trials/traumatic-brain-injury) cannot be substituted for a formal concussion history: A detailed history of prior concussions is essential in the management of a patient presenting with a brain injury.

Anonymous Patient Answer

Does : cognitive support technology (cst) improve quality of life for those with brain injuries?

Cst had a positive effect on QoL-AIT and QoL-CPS, in the domains of physical well-being, social-well-being, and global health in the first month post-injury, and throughout the 12-month period post-injury. Findings of this study support the need for a larger randomized prospective trial of cst with a control arm for the effectiveness of cst in improving QoL measures post-TBI.

Anonymous Patient Answer

Who should consider clinical trials for brain injuries?

Patients may want information before considering enrollment in a clinical trial. Trial-specific information is available on the clinicaltrials.gov database. We recommend a one-page brochure is developed for patients to consider and discuss with clinicians.

Anonymous Patient Answer

What are the common side effects of : cognitive support technology (cst)?

It is essential to evaluate the common side effects of cst in patients with moderate to severe brain injury. The side effects that we have described can be managed by using self-management approaches, a more conservative use of medications and the use of an objective scale to record the patient's data. Further research is required to determine the effectiveness and cost effectiveness of cst in an extended clinical scenario.

Anonymous Patient Answer

Have there been any new discoveries for treating brain injuries?

As neuroprotective treatments become more common; new drugs such as neuroinflammaging-related drugs will be able to treat brain injuries as well as preventing them. As more research is completed, new treatments will surely be found to help brain injury patients for the future.

Anonymous Patient Answer

Has : cognitive support technology (cst) proven to be more effective than a placebo?

There is a growing interest in utilizing cognitive support with individuals with brain injury in order to optimize behavioral and neuropsychologic outcomes and reduce the severity of the symptoms experienced by those with severe brain injuries.

Anonymous Patient Answer
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