CLINICAL TRIAL

Full-band Electrocorticography for Brain Injuries, Traumatic

Waitlist Available · 18+ · All Sexes · Cincinnati, OH

Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)

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About the trial for Brain Injuries, Traumatic

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

Treatment Groups

This trial involves 2 different treatments. Full-band Electrocorticography is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Full-band Electrocorticography
DIAGNOSTICTEST
Treatment Algorithm
COMBINATIONPRODUCT
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
(1) clinical indication for emergency craniotomy with dural opening to treat acute TBI within 72 hr post-trauma
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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: 6 months post-injury
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months post-injury.
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 Full-band Electrocorticography will improve 1 primary outcome and 4 secondary outcomes in patients with Brain Injuries, Traumatic. Measurement will happen over the course of During the period of intensive care invasive monitoring, up to two weeks after injury.

Burden of elevated intracranial pressure
DURING THE PERIOD OF INTENSIVE CARE INVASIVE MONITORING, UP TO TWO WEEKS AFTER INJURY
The time integral of the continuously monitored intracranial pressure signal above 22 mmHg will be computed for each patient as the measure of burden. The burdens computed for patients will be compared between the two randomization arms.
Burden of spreading depolarizations
DURING THE PERIOD OF INTENSIVE CARE INVASIVE MONITORING, UP TO TWO WEEKS AFTER INJURY
Spreading depolarization events will be scored based on review of electrocorticographic recordings. The number of depolarizations per recording day over the period of monitoring will serve as the measure of total burden. The burdens computed for patients will be compared between the two randomization arms.
Burden of cerebral hypoxia
DURING THE PERIOD OF INTENSIVE CARE INVASIVE MONITORING, UP TO TWO WEEKS AFTER INJURY
The time integral of the continuously monitored cerebral oxygenation below 20 mmHg will be computed for each patient as the measure of burden. The burdens computed for patients will be compared between the two randomization arms.
Burden of low cerebral perfusion
DURING THE PERIOD OF INTENSIVE CARE INVASIVE MONITORING, UP TO TWO WEEKS AFTER INJURY
The time integral of the continuously monitored cerebral perfusions pressure below 60 mmHg will be computed for each patient as the measure of burden. The burdens computed for patients will be compared between the two randomization arms.
Glasgow Outcome Score-Extended
6 MONTHS POST-INJURY
Scores on the GOS-E will be compared between the two randomization arms

Who is running the study

Principal Investigator
J. H.
Prof. Jed Hartings, Professor
University of Cincinnati

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?

Treatment should be tailored to injured individuals' needs from the initial management of the injury to ongoing care after the injury. Treatment is based on whether the injury is a concussion, a traumatic brain injury, or a non-traumatic neurodegenerative disorder. Common brain injuries that require treatment include traumatic brain injury, traumatic brain injury with seizures, and traumatic brain injury without seizures. Common treatments include surgery, medical and physical therapy, and medication. Most physicians and rehabilitation specialists can provide effective treatment for common non-traumatic brain injuries, including mild traumatic brain injury, post-concussive syndrome and traumatic brain injury with post-traumatic seizures.

Anonymous Patient Answer

What is brain injuries, traumatic?

Traumatic brain injuries (TBIs) are common injuries occurring in the American population. They vary in severity and are influenced by multiple factors. This article presents a concise and informative article on how to care for TBIs.

Anonymous Patient Answer

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

About 3 million individuals will sustain an acute traumatic brain injury a year in the United States. As a result of these injuries medical expenditures will increase $16,700,000 annually.

Anonymous Patient Answer

What are the signs of brain injuries, traumatic?

There are many possible neurological signs that could develop after an injury. A comprehensive neurological examination should be performed to diagnose the cause of the neurological deficits.\n\n- Abnormal sensations in the arms or legs\n- Diffuse muscle weakness or paralysis\n- Changes to vision such as double vision or loss of sight.\n- Problems with hearing, such as ringing in the ears.\n- Difficulty with the eye's coordination or focusing (particularly when the eyes are closed.\n- Headache.\n- Changes to behavior or perception of reality.

Anonymous Patient Answer

Can brain injuries, traumatic be cured?

Trauma cannot be cured. Attempts to avoid or avoid treatments of traumatic brain injury have proven ineffective in relieving the symptoms, prolonging the time spent in hospital, and increasing medical costs. Traumatic injury in the head is an inescapable reality for both patient and healthcare practitioner and cannot be avoided. In the worst-case scenario, this injury could only lead to death. We propose that efforts to reduce injury and recovery to the brain cannot be cured but can be managed. This paper provides a systematic overview of the current status of interventions designed to prevent and treat traumatic brain injury without success.

Anonymous Patient Answer

What causes brain injuries, traumatic?

Many factors may play a role in the causation of head injuries. For instance, sporting injuries are more common among adolescents and are not related to age. The most frequently injured bones are the long bones of the leg and arms, and the lower body.

Anonymous Patient Answer

Does brain injuries, traumatic run in families?

The present study suggests that traumatic brain injuries and TBIs are highly prevalent across all families, irrespective of socioeconomic status. Data from a recent study are reassuring, given that these injuries, which can potentially lead to long-lasting and detrimental psychological problems are growing in number. While the family is the first resource to deal with these injuries, its impact on socio-psychological well-being and that of the child remains to be ascertained.

Anonymous Patient Answer

Has full-band electrocorticography proven to be more effective than a placebo?

Findings from a recent study of this study are not entirely consistent with previous studies which found that placebos have equivalent efficacy to true sham sham ECoG. However, further investigations are required.

Anonymous Patient Answer

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

A more holistic view of treating brain injuries is required for an effective recovery. New therapies should be introduced as soon as possible for better outcomes.

Anonymous Patient Answer

Does full-band electrocorticography improve quality of life for those with brain injuries, traumatic?

Full-band ECG is an efficient means of documenting all-important brainstem function, and ECOG enables the inclusion of patients for whom the clinical course might otherwise be difficult.

Anonymous Patient Answer

How does full-band electrocorticography work?

The amplitude and morphology of the local and distant components in response to a short tone burst indicate that the local component is a summation of afferent, synaptic and tonic inhibition. The local component is the result of the activation of synaptic and somatic fibers within the brainstem, while the distant component indicates cortical activation. The localization and amplitude of both components are constant throughout mRS.

Anonymous Patient Answer

What is full-band electrocorticography?

Results of the study show clear differences between BECoG and EEG of the frontal cortex and between the results of BECoG in the left and right cerebral hemispheres and the values from both hemispheres (for comparison see Table 3). It is probable that the cerebral cortex is the site of the epileptogenic activity; so that an "electrodermal effect" or "electric effect" is detected in a group of patients with an epileptic syndrome. It is worthwhile to emphasize that our idea is not to determine the location of epileptogenic zones in the cortex; only to identify the epileptic foci with BECoG.

Anonymous Patient Answer
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