"Help us identify risk factors for developing seizures after a brain injury"
moderate brain injury, severe brain injury
The purpose of this study is to identify risk factors for developing seizures after a brain injury. We will study potential brain changes contributing to the development of seizures including changes in the blood, changes in brain structure, and changes in brain activity seen on electroencephalography (EEG)
This study requires
• Blood samples will be collected Days 1, 3, 5, 15, 30, 90, and 180 after your injury. Total amount of blood collected will be approximately two tablespoons each time. • Telephone outcome questionnaires will be conducted at 1, 3, 6, 12, and 24 months after your injury. This will take approximately 45 minutes of your time
Data will be obtained both from the activities described here and also from data generated during your standard clinical care
Who can participate?
Inclusion Criteria: • Acute Traumatic Brain Injury (TBI) • Age 12-100 are eligible • GCS 3-12 • Hemorrhagic contusional injuries to frontal and/or temporal lobes. • Polytrauma including long bone fractures, blunt trauma, abdominal trauma or similar will be allowed. • Penetrating TBI if cEEG is feasible and survival for 2 years is feasible, recognizing that MRI may not be feasible with some forms of penetrating trauma
Exclusion Criteria: • Ages 11 years or younger • Patients with diffuse axonal injury in the absence of hemorrhagic contusions or skull fracture, and isolated epidural hemorrhages that improve after evacuation. • Inability to undergo MRI within 2 weeks of injury (bullet, metal implant, and pacemaker) studies in the acute and chronic setting. • Pregnancy • Inability to undergo MRI within 2 weeks of injury • Pre-existing Neurodegenerative Disorders • Pre-existing seizures • Pre-existing dementia • Isolated anoxic brain injury • Incarceration present or pending
Benefits and risks of participating
There are no benefits to you from your taking part in this research:
We cannot promise any benefits to others from your taking part in this research. However, your participation in this study may yield important information to the scientific/medical communities about the occurrence of post-traumatic epilepsy. It may help direct future treatment strategies to improve the outcome of future patients who suffer from this injury.
This study involves minimal risk. Possible risks and discomforts are listed below:
• Blood Draw Risks: Blood draws may cause temporary discomfort from the needle stick, bruising and, rarely, infection and fainting. If more than one unit of blood is to be drawn within an 8-week period, a medically appropriate precaution concerning subsequent blood donation is required. • MRI risks: The combination of the confined space and noise of the MRI machine may cause discomfort for those that are uncomfortable in closed areas. • Telephone Interview: There are a number of questionnaires that need to be completed for this study. You may find the telephone interviews to be frustrating or upsetting. Some of the questions the researchers ask you may be upsetting, or you may feel uncomfortable answering them. If you do not wish to answer a question, you can skip it and go to the next question. • Medical Information Privacy: There may also be risks to your privacy. The researchers will store study records and other information about you in a secure location and will grant access only to those with a need to know. However, just like with other personal information kept by your health care providers, your banks, and others, even these safeguards cannot guarantee absolute protection of the data. If private information gets into the wrong hands, it can cause harm. Although rare, there are reported cases of breaches that have resulted in discrimination in insurance or employment.
You will be followed closely by the study doctor for the entire time you are hospitalized. The researchers will observe you carefully for any harmful side effects.