Update

Inside: 2 | TRACK-TBI Imaging Success 3 | Personal Story 4 | One Mind Portal Data Sets 8 | Donate!
Update
Fall 2016
TRACK-TBI & AURORA MEETING
Making Research History – Again
One Mind is proud of the amazing accomplishments the TRACK-
TBI and TED investigators have made. It is groundbreaking in
the research world that halfway through their innovative study
the team is turning data into the Federal Drug Administration
(FDA), which is the first step in the qualification process
for both imaging and liquid TBI diagnostic biomarkers.
We have been told that an FDA letter of support for the
investigators work and findings is forthcoming. Once issued,
it will be a public acknowledgement that the One Mind
model of large-scale collaborative science – focused on the
patient and guided by open science principles – works!
was exciting in itself. What made it more than exciting was
the identification of a number of significant areas that they
can work together and their willingness to do exactly that.
The fact that with the support of SFF, One Mind can be the
convener that brings together researchers from two very large
studies, being funded by two separate institutes at the NIH
(NINDS and NIMH), demonstrates that we are knocking down
the silos that are impeding the translation of science from the
“bench to the bedside.” Although no one keeps historical
records of such meetings, those who should know indicated
that a collaborative like this was indeed unprecedented.
TRACK-TBI and TED investigators have another first to
report. Last month they met in Seattle, WA for a day and a
half seminar sponsored by One Mind, with funding from the
Schultz Family Foundation (SFF), to work with investigators
studying post-traumatic stress (PTS). The PTS study is called
Aurora and follows a longitudinal study protocol that is
almost identical to the protocol being used for TRACK-
TBI. Specifically, enrolled patients consist of those that are
brought to the emergency department suffering from posttraumatic
trauma and follow their progression for one year.
Given the high comorbidity of PTS and TBI, bringing these
two teams together to look for ways that they can collaborate
The addition of the Aurora study will not only allow
One Mind to help those with PTS and TBI, but it will
provide us the opportunity to explore the causes
of depression, anxiety, pain and other physical and
mental conditions associated with these injuries.
This expansion of our focus goes a long way in making good on
the One Mind assertion that we are not just about PTS and TBI.
One Mind is committed to proving that large-scale collaborative
research guided by open science principles is the key to
making short-term progress on better diagnostics, treatments
and yes, someday cures for neurodegenerative diseases.
ONE MIND | onemind.org 1

TRACK-TBI Imaging Success
Spurs TED Initiative’s FDA
Regulatory Efforts
The NIH-funded TRACK-TBI study goal to obtain MRI scans from 600 patients with traumatic brain injury (TBI), at both two weeks and six
months following injury has been achieved. Many thousands of hours of effort by the Imaging Core scientists, research coordinators, radiology
technicians, and data engineers at the 11 clinical sites have created the largest repository of serial, standardized, high-resolution brain images
from a single TBI study. This well-curated dataset is now being leveraged by co-Investigators from the Department of Defense-funded TBI
Endpoints (TED) Initiative to achieve regulatory qualification of a neuroimaging tool expected to be used in future TBI trials of drugs or other
therapeutic agents. According to UCSF neuroradiologist and Study Imaging Core Leader, Pratik Mukherjee, MD PhD, “a huge hurdle in TBI
research has been the lack of standardized brain imaging protocols. Our success with standardizing 3T MRI brain scanning protocols across 11
clinical sites and three different MRI machine vendors allows us to truly compare ‘apples to apples’ for the first time.”
We have learned that recruitment for TRACK-TBI participation is the easier research task; helping patients follow up for imaging, blood tests,
and detailed outcome assessments is more challenging. Many of our patients are unable to travel independently, and those that can often
require additional support. Thanks to very generous funding from One Mind, our ability to provide stipends and transportation for follow-up visits
resulted in nearly 60% of patients getting to their two-week MRI scan and nearly 80% of these patients returning at six months for a second scan.
The OsiriX screen capture shows how different neuroradiologists can independently mark their
assessment of brain injury features directly onto the image for precise comparison. Using software plugins
specially designed by TRACK and TED imaging experts, each reader can delineate each abnormality.
Here, Neuroradiologist 1 delineated a lesion in red on her copy of the image, and Neuroradiologists 2
and 3 independently marked the lesion on theirs, using a yellow arrow and blue circles, respectively. The
images are then laid over one another, permitting a confirmed, precision diagnosis.
The extensive ‘apples to apples’
imaging dataset is, in large part,
what the TRACK and TED teams,
led by UCSF neuroradiologist,
Esther Yuh, MD PhD, have used
to make the case to FDA that the
more precise characterizations
provided by MRI, as well as
conventional CT scans, should
be adopted as a qualified
“Medical Device Development
Tool [MDDT]” for clinical and
therapeutic trials. The FDA has
enthusiastically agreed to this
review, and the investigators
are engaged in the first-ever
MDDT “incubator” project with
FDA’s Center for Devices and
Radiological Health.
Dr. Yuh and her colleagues
designed a framework using the
OsiriX image viewing application
that enables investigators and
clinicians to systematically apply imaging common data elements (CDEs) to evaluate MRI scans for lesions in patients with suspected TBI.
Ultimately, this CDE tool will support the uniform diagnosis of TBI and help select patients for TBI clinical trials.
In addition to work with the FDA, the analytical teams will examine structural and functional findings from the scans to identify connections
between the images and the concurrently collected neurocognitive and biochemical assessments, as we continue our precision medicine
approach to the diagnosis and treatment of TBI.
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SHARING PERSONAL STORIES
Telling and listening to stories is powerful and relatable – in our case, it’s stories from patients,
family, friends, caregivers and doctors who are affected by brain diseases and injuries. This is
why we at One Mind believe in providing a platform for them to be shared.
How a Traumatic Brain Injury Steered Me to My Dream Career
By Mary Ellen Chiles
After working in fishing
lodges in Alaska for five
summers and traveling
during the offseason, I
decided to challenge
myself: I would spend
one year in one place.
I returned to
Holden Village,
an abandoned copper mine in Chelan, WA that is
now a year-round retreat center. I’d spend the year
welcoming people in need of rest and reflection.
While there I slipped on a patch of ice and hit
my head a few days before Christmas 2013.
I took the boat across Lake Chelan to see a
doctor. “Just a mild concussion,” he said.
I felt relieved. Eight years prior I’d hit my head in a
bicycling accident. I only remember hitting my front tire
on a median. Then I heard car doors slam and people
running toward me to help. They offered to take me to
the hospital. I said no. I wanted to keep bicycling. I felt
dizzy and confused for a few months, but it went away.
After the 2013 concussion, I returned to Holden in time for
Christmas. I felt nauseous for four months and dropped
15 pounds. I wanted to stay up with my friends under
the stars. Instead, I slept, first for 15 hours a day, then
gradually fewer. I left Holden for two months to recover at
my parents’ house in Missouri, returning in the spring after
the ice started to melt. I watered lawns and pulled weeds.
When I felt dizzy and fatigued, I stopped and slept.
Most people understood. The others I ignored.
It was my brain. I had to listen to it in order to
recover. Every day, sometimes hourly, I reminded
myself that I would someday return to normal.
I also started listening to other things, like my
fatigue with seasonal work. I wanted to focus on
photography. I wanted to take all of my Alaska
stories and write them down. I didn’t know how.
After eight months the doctor said I was back
to normal. But I kept feeling dizzy. I cringed
under bright light. I still searched for words.
After Holden, I moved to Seattle. I still battled fatigue
and nausea, which I treated with acupuncture. I worked
30 hours a week at a Starbucks on Lake Washington.
I started to write baseball poetry for my website.
I started exhibiting my photography.
Nineteen months after hitting my head I decided to earn
a Master’s in creative writing at my alma mater, Missouri
State. I visited a neuromuscular therapist for help with
occasional dizziness during my first semester, but I finally
felt symptom-free by Christmas, two years after I fell.
I earned a 3.95 GPA my first year. I’ve started a
photography business, and am writing for the
alumni association as a graduate assistant. As for
my thesis: I’m finally writing about Alaska.
ONE MIND | onemind.org 3

ONE MIND PORTAL
(APOLLO) UPDATE
One Mind Portal Adds Data on Depression
In addition to enhancing the functionality of the One Mind
Portal, we have also been working to incorporate additional data
sets within the Portal. Recently, we have been working with the
National Network of Depression Centers (NNDC,
http://www.nndc.org) to begin integrating some of their data.
The NNDC consists of 26 leading clinical and academic Centers
of Excellence in the U.S. that are working to transform the field of
depressive illnesses and related mood disorders to rapidly move
findings from the research lab to the clinical setting.
The first data set added was the NNDC Clinical Care Registry
(CCR). The Clinical Care Registry (CCR) was established in
2010 and collected data through the end of 2014. The CCR
was designed to utilize the NNDC’s Screening and Monitoring
Package to implement a long-term, prospective, observational,
multi-center patient registry. The CCR data set includes data on
1,500+ patients presenting with a depressive episode from 18
participating NNDC Centers of Excellence.
The NNDC Repetitive Transcranial Magnetic Stimulation Registry
(rTMS) was the second data set to join the Portal platform. NNDC
established the rTMS in 2011 and collected data through the end
of 2014. The goals of the study were to:
• Characterize the variation in rTMS therapy in regular
clinical practice
• Measure response and remission rates
• Explore moderators of treatment response
The rTMS data set includes data on 60+ patients presenting with
a depressive episode from nine participating NNDC Centers of
Excellence.
Initially, these two data sets will be available for download to
approved Portal users. Following this, they will also be available to
approved Portal users via the tranSMART analytics tool.
We continue to look for valuable data sets that can be integrated
with the Portal platform. If you have data that you would like to
contribute, please contact us at portal@onemind.org.
“Access to de-identified research data on traumatic brain injury and depression is an
exciting step toward the One Mind vision of open science and collaboration. Depression
is a common symptom of traumatic brain injury and we need to learn more about their
interactions and the potential for treatments, like transcranial magnetic stimulation, to
enhance recovery. We look forward to working with other brain researchers to not only
make their data available on the One Mind Portal, but to continue breaking down the
silos and accelerating progress towards finding better diagnostics and treatments.”
– Ramona Hicks, PhD, Chief Scientific Officer, One Mind
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CENTER-TBI HAPPENINGS
Patient Recruitment Success
Data Collection
In June 2016, CENTER-TBI passed the halfway mark of 2,700
patients recruited into the core study (full study protocol testing).
They are now over the 3,200 mark, and over 13,800 patients
have been enrolled in the registry (basic testing – patients who
are recorded as presenting a traumatic brain injury (TBI) upon
arrival to the site). Many thanks to all the sites for this substantial
achievement!
A few sites have already reached their target recruitment and will
no longer be enrolling new patients. Other sites have just recently
started recruitment, and the hope is that with everyone’s collaborative
input, these sites will be able to complete their recruitment
by the summer of 2017.
As sites are gathering data, three strata will be used,
differentiated by the patient care path:
1.
2.
3.
Patients seen in the emergency room (ER) and discharged
(ER stratum)
Patients admitted to hospital, but not to the intensive care
unit (admission stratum)
Patients admitted to the intensive care unit (ICU;
ICU stratum)
Most likely, the target recruitment for the ICU stratum will be
reached by this December. Although further enrollment in the ICU
stratum will probably be stopped at that time, enrollment in the
High Resolution sub-study of the ICU stratum will continue until
the end of the core study; along with the ER and admission strata.
Standardizing Data Collection – Additional Initiatives
Building on the infrastructure of CENTER-TBI, a number of initiatives
for broader TBI applications and more in-depth analysis are
currently taking place. These include:
• A project on integrating clinical features and
biomarker assessment;
• A project on developing a new traumatic axonal injury
classification scheme based on improved MR Imaging;
• A new international collaboration on neuroinflammation
in TBI; and
• A large international study on genetic associations
in neurotrauma.
We wish these initiatives success and look forward to their progress!
Figure: Phase I and II concept of CENTER-TBI project
ONE MIND | onemind.org 5

ONE MIND PORTAL
(APOLLO) UPDATE
PATIENTSLIKEME RESEARCH SURVEY #2:
TBI RESULTS ARE IN!
We have joined forces with our partners at PatientsLikeMe to learn more about what issues are important to the
members of their online post-traumatic stress (PTS) and traumatic brain injury (TBI) communities. Over the coming
months, members will be completing a series of surveys to better understand their PTS and TBI experiences, and their
perspectives will be brought forward to change our understanding of PTS and TBI.
Survey #2: Seeking Treatment for TBI
We asked study participants a series of questions about why they seek or do not seek treatment for their TBI.
Here is what was found…
The top reasons for not seeking treatment were because of not
knowing treatment was available or where to get it.
The top reason for seeking treatment was because of problems with
cognitive functioning – including social and family relationships.
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Here is what some of the survey participants had to say about their experiences seeking or not seeking treatment…
Seeking Treatment
Not Seeking Treatment
“I am trying to find this new me everyone keeps
talking about.”
“I hope to regain my brilliant mind and peace and
focus and love.”
“I do not think that I need treatment.”
“I do not know what treatment is available.”
“There is no treatment available close to my home.”
“Learn how to interact with other people again. With a very
iffy memory I am not comfortable meeting people because
the chances that I won’t remember them is very high.”
“I do not think that TBI treatment will work.”
“I believe my TBI has pretty much resolved itself.”
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DEVELOPMENT
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