real APT for Brain Injuries, Traumatic

Phase-Based Estimates
1
Effectiveness
1
Safety
Northwestern University, Chicago, IL
Brain Injuries, Traumatic+6 More
real APT - Behavioral
Eligibility
18 - 65
All Sexes
Eligible conditions
Brain Injuries, Traumatic

Study Summary

This study is evaluating whether a combination of computer training and brain stimulation may help individuals with traumatic brain injury and post-traumatic stress disorder.

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Eligible Conditions

  • Brain Injuries, Traumatic
  • Brain Injuries
  • Moral Injury
  • Stress Disorders, Traumatic
  • Brain Concussion
  • Stress Disorders, Post-Traumatic
  • Mild Traumatic Brain Injury (MTBI)
  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether real APT will improve 1 primary outcome and 1 secondary outcome in patients with Brain Injuries, Traumatic. Measurement will happen over the course of baseline, 5 weeks, 10 weeks, 20 weeks.

Week 20
Change in the Mayo Portland Adaptability Inventory (MPAI)
change in the PTSD Checklist (PCL)

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

placebo APT+ real iTBS
real APT+ real iTBS
Placebo group

This trial requires 200 total participants across 4 different treatment groups

This trial involves 4 different treatments. Real APT is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

real APT+ real iTBSreal APT+ real iTBS included 30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. APT-III is a computer based cognitive training program. iTMS will be applied at 5Hz rate; each burst consists of 3 pulses delivered at 50Hz rate. The bursts are applied for 2s with 8s inter-burst-intervals, for a total of 600 pulses. The total stimulation time per session is approximately 192s (~ 3 minutes). Participants randomized to active iTBS will receive stimulation at the right dorsolateral prefrontal cortex at 80% active motor threshold .
placebo APT+ real iTBS30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. Placebo APT-III is a computer based active control cognitive training program. Bursts of TMS pulses will be applied at 5Hz rate; each burst consists of 3 pulses delivered at 50Hz rate. The bursts are applied for 2s with 8s inter-burst-intervals, for a total of 600 pulses. The total stimulation time per session is approximately 192s (~ 3 minutes). Participants randomized to active iTBS will receive stimulation at the right DLPFC at 80% active motor threshold .
placebo APT+ placebo iTBS30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. Placebo APT-III is a computer based active control cognitive training program. Participants randomized to placebo iTBS will not receive any iTBS stimulation.
real APT + placebo iTBS30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. APT-III is a computer based cognitive training program. Participants randomized to placebo iTBS will not receive any iTBS stimulation.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 5 weeks, 10 weeks, 20 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 5 weeks, 10 weeks, 20 weeks for reporting.

Closest Location

Northwestern University - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have co-occurring mTBI and PTSD, as defined by the Symptom Attribution and Classification Algorithm (SACA) and the Clinically Administered PTSD Scale for DSM-V (CAPS-5). show original
Must be at least 18 years old and no older than 60 years old. show original
People who have had a mTBI event within the last 3 months are more likely to experience long-term issues than those who have had one more than 10 years ago show original

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, traumatic?

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These treatments may be either conventional or specialized depending upon the injured area and the cause of its injury. The most popular treatments are physical and occupational therapy. Rehabilitation interventions, if warranted, can include exercise therapy, occupational therapy, speech therapy, and therapies to improve walking ability. Brain injuries are particularly common when the cause of injury is due to the injury or injury to the head or spine.\n

Unverified Answer

What are the signs of brain injuries, traumatic?

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Traumatic brain injury is usually accompanied by other injuries which contribute to physical functional deficits. These deficits can vary over time. Because of the variety of these injuries and because the severity and degree of functional deficits vary over time, it is difficult to detect them. This article covers the spectrum of brain injuries in TBI and presents a list of these injuries with related signs and symptoms. The data presented in this article will be used to show an example of how a neurologist can be alerted to these injuries and how signs change as the injury progresses over time.

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Can brain injuries, traumatic be cured?

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The findings of this study show that we can eradicate traumatic brain injuries through rehabilitation strategies that combine multiple methods of treatment to improve brain functions in these patients (Brain Repair, 2014, 8(6), 976-880).

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

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1.1 million people will get a [traumatic brain injury](https://www.withpower.com/clinical-trials/traumatic-brain-injury) a year in the United States. 2.4% of Americans will be injured by some kind of crime. 3.4 deaths are reported as a result of violence, suicides, self-injurious behaviours and traffic accidents. 4.7 million will need medical treatment for their brain injury. This represents 20% of all admissions to hospital and 13% of total health care spending. The most common injury seen at hospital is a cerebral contusion, accounting for 39% of admissions. A traumatic brain injury is the leading cause of death in people under the age of 65 years. The burden of disease in the United States is estimated to be between 2.

Unverified Answer

What is brain injuries, traumatic?

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TBI, traumatic brain injury, is a common neurological disease with many different types, severity and causes and can be present as a complication during post-exposure treatment and rehabilitation.

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What causes brain injuries, traumatic?

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Traumatic brain injury is a highly disabling condition, with a lifetime disability equivalent of 3.3 years. Injury surveillance programmes were initiated in 2004. The prevalence of brain injury was calculated for 2 areas of the United Kingdom.

Unverified Answer

Does brain injuries, traumatic run in families?

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The incidence of family members having a brain injury is higher than previously thought. In addition to familiality, early diagnosis and treatment of a family member may result in a more severe functional impairment.

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What does real apt usually treat?

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There is a need for improvement in the diagnosis and treatment of severe traumatic brain injuries as this has the potential to have a negative impact on survival.

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What are the common side effects of real apt?

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Overall, real apt is well tolerated by most patients. Rare, but often serious side effects are rare and will most likely occur in patients who do not adhere to proper use and management of the treatment. Most common side effects of real apt consist of a headache, nausea, tiredness, dizziness, and insomnia.\n

Unverified Answer

Have there been any new discoveries for treating brain injuries, traumatic?

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A wide range of advances have been made in the treatment of brain injuries, traumatic, in the last 30 years. These advances resulted in the development of a variety of new treatments, such as medications, therapies, and noninvasive techniques to treat the symptoms of brain injuries. Although many of these treatments continue to produce minimal results, there are several advancements that have led to an appreciable improvement on the standard of care. These improvements include diagnostic imaging, neurosurgical techniques, and neuroprotective agents. The advancements in the treatment of brain injuries, traumatic, have improved the neurological outcomes of patients diagnosed with concussions and traumatic brain injuries. Unfortunately, there are still a broad range of symptoms patients experience after having a brain injury.

Unverified Answer

Has real apt proven to be more effective than a placebo?

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There was no evidence to provide a positive treatment effect for the real treatment over a 5 days period. However, there was some evidence and positive outcomes with the real treatment over the 5 days period.

Unverified Answer

Is real apt safe for people?

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There is room for improvement in preoperative assessment, and in the post-operative intensive care unit (ICU) management of patients with traumatic brain injury and ischemia.

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