You are on page 1of 2

COBRIT

PARTICIPATING ACADEMIC MEDICAL CENTERS

YOUR PARTICIPATION COUNTS


Traumatic brain injury is a serious health concern in the
United States. By providing researchers with valuable information about the effects of the natural substance citicoline,
COBRIT participants may have the opportunity to contribute
to their own health and to the health of others who sustain
brain injuries. Today, no known drugs or treatments exist for
patients with memory loss and problems with clear and logical thinking that can result from traumatic brain injury.

BE A PART OF COBRIT
TEMPLE UNIVERSITY, PHILADELPHIA, PA
COBRIT is a study sponsored by the U.S.
government and conducted at eight academic
medical centers to assess whether the natural
with memory and clear thinking that can

Here are just a few numbers that show how


widespread traumatic brain injury is in the United States:

Have sustained a traumatic brain injury

 An estimated 1.5 million head injuries occur every year.


 An estimated 1.6 million to 3.8 million sports-related head
injuries occur each year.

OF

ALABAMA

AT

BIRMINGHAM, AL

Tel. 205-934-7373

UNIVERSITY

UNIVERSITY
meet the following criteria:

Be between the ages of 18 (19 in

Alabama) and 70
Speak English
Be able to enroll in the study within

OF

MARYLAND, BALTIMORE, MD

Tel. 410-328-5332

occur as a result of a traumatic brain injury.


To be included in the study, patients must

brain injuries most commonly caused by falls, motor


vehicle crashes, sports injuries, assaults or simple falls at
work or in the home.

UNIVERSITY

substance, citicoline, can improve the difficulties

When the study is complete in 2011, it is expected


that researchers will know whether citicoline can improve
cognitive symptoms in people with traumatic brain injuries.

 It is estimated that more than 5 million Americansabout


2 percent of the populationlive with disabilities from

Tel. 215-707-7200 or 215-707- 4071

Preserving
Brain and
Cognitive
Health

OF

PITTSBURGH, PITTSBURGH, PA

Tel. 412-647-1025 or 412-381-1826

UNIVERSITY

OF

TENNESSEE HEALTH SCIENCES CENTER,


MEMPHIS, TN
Tel. 901-545-6374

UNIVERSITY

OF

TEXAS, SOUTHWESTERN MEDICAL CENTER,


DALLAS, TX

Tel. 214-648-7241 or 214-648-7613

UNIVERSITY

OF

WASHINGTON,

SEATTLE,

WA

Tel. 206-744-9357

24 hours after the injury


Commit to participating in the study for a

VIRGINIA COMMONWEALTH UNIVERSITY, RICHMOND, VA


Tel. 804-828-9528 or 804-338-0481

total of 6 months

 Blasts are a leading cause of brain injury among active


duty military personnel in war zones. It is estimated that
between 10 percent and 20 percent of Iraq veterans, or
150,000 to 300,000 U.S. service members, have some level
of traumatic brain injury.

COBRIT DATA COORDINATING CENTER


Columbia University, New York, NY
For more information visit: www.tbi-ct.org

For more information on traumatic brain injury:


www.ninds.nih.gov/disorders/tbi/tbi.htm
www.mayoclinic.com/health/traumatic-brain-injury
www.cdc.gov/ncipc/tbi/TBI.htm

The U.S. Government's Eunice Kennedy Shriver


National Institute of Child Health and Human
Development is funding COBRIT.

COBRIT
The

Citicoline Brain Injury Trial

What to Expect as a
COBRIT Participant
COBRIT participants may have
the opportunity to contribute
to their own health and to
the health of others who

WHAT IS TRAUMATIC BRAIN


INJURY?
Although the brain is protected by a hard skull, it is
delicate enough to be hurt in many ways. When a person falls
and hits a hard object-such as a floor or sidewalkthe brain
can be badly bruised when it collides against the inside of the
skull. In whiplash injuries, nerves deep inside the brain are
stretched or torn when the head drastically seesaws back and
forth. When a skull is fractured in an accident or assault, the
brain receives a damaging shock. And just being near an
explosion can be destructive to the brain, even when it is not
directly hit, as has happened to soldiers in Iraq.
Traumatic brain injury also may cause psychological
symptomsdepression, anxiety, inappropriate anger and
aggression; memory loss; and cognitive difficultiesproblems
with clear and logical thinking. These symptoms may not
appear until days or weeks following the injury and may even
be missed, since someone with a brain injury may look fine,
even though he or she is behaving or feeling differently than
before the injury.
The psychological, memory and cognitive problems
that can develop as a result of a traumatic brain injury are
often severe enough to interfere with a person's ability to
perform the tasks of normal daily life. No drugs or treatments
currently exist, however, to treat the memory loss and
thinking problems associated with traumatic brain injury.

sustain brain injuries.

WHAT

IS

COBRIT?

The Citicoline Brain Injury TrialCOBRITis a nationwide


research study funded by the National Institutes of Health.
It is designed to learn whether a substance naturally
produced by the bodyciticolinewill help patients make a
better recovery after traumatic brain injury. In particular,
the study seeks to determine whether citicoline improves
difficulties with memory and clear thinking that can occur
after a head injury.
Despite numerous research studies, no drugs or
treatments have been found to be effective for these conditions, either at the time of injury or afterward. Results from
COBRIT may help determine how best to treat patients with
brain injuries so that they can resume their normal daily
activities.
A total of 1,292 patients with traumatic brain injury
will be enrolled in COBRIT at eight leading academic medical
hospitals around the country. The 5-year-long trial will last
until 2011.

WHAT

IS

CITICOLINE?

Citicoline is a substance found naturally in the body that


has been shown in some studies to protect the nerves of the
brain. Citicoline is a building block
for certain chemicals found in the
brain called neurotransmitters, which
enable nerve cells to communicate
with one another. Citicoline is a
required building block for the neurotransmitters involved in memory.
Some studies have shown
that citicoline may help preserve
memory in healthy people and improve mild memory problems associated with aging. It has been widely used for many
yearsespecially in Europe and Japanto treat problems with
memory or clear thinking that may follow a stroke or head
injury. The goal of COBRIT is to try to determine whether
citicoline, when taken as a
supplement, can in fact improve these symptoms in brain
injured people.

Because it is believed that brain damage can continue to


worsen in the hours after an injury, patients enrolled in
COBRIT will be given citicoline within 24 hours of their
injury. They will be monitored closely by study staff during
the first seven days and followed throughout their hospitalization. These steps will be in addition to the regular tests
and medical care normally provided to patients with head
injuries.
Half of the COBRIT participants will take citicoline; the other half will take a placebo, which looks and
tastes just like citicoline but contains no active medication.
All participants will take study medication for approximately 90 days. Assignment to the group that takes either citicoline or placebo will be random, meaning there is a 50-50
chance that someone may be assigned to either group.
This random assignment during medical studies is the best
way for researchers to learn whether a drug or treatment
works.
Three follow-up visits will take place at approximately 1 month, 3 months and 6 months after enrollment.
The research staff will make these visits as convenient as
possible for the participant, such as scheduling them on
the same day as clinical appointments when possible. At
these visits, the participant will complete an evaluation of
thinking skills, such as memory and concentration. This is
a good way to measure recovery from head injury. The
results of the evaluation can be provided if desired and
there is no charge for any of the tests administered as part
of the research study.
As in all research studies, before the patient is
enrolled in COBRIT, a staff member will discuss the study
in detail with the patient or relative and will answer all
questions. Then the patient or family member must sign a
consent form before enrollment.