Research

Spaulding-Harvard Traumatic Brain Injury Model System (SH-TBIMS)

The Spaulding-Harvard Traumatic Brain Injury Model System (SH-TBIMS), led by Dr. Joseph T. Giacino, was selected by the National Institute of Disability, Independent Living, and Rehabilitation Research (NIDILRR) to receive federal funding as a TBIMS center.

TBIMS research is responsible for almost 500 peer-reviewed publications and has facilitated the development of TBI medical care guidelines, comprehensive diagnostic procedures, rehabilitation approaches, and more. Within the 16 TBIMS centers throughout the nation, exceptional rehabilitation additionally serves to improve injury treatment and outcomes for future patients.

Study Contact:

Mario Feranil | Email: mferanil@mgb.org

TBIMS National Database

Some patients who enter the Brain Injury Program at Spaulding Rehabilitation Hospital Boston and Spaulding Hospital Cambridge are eligible to anonymously contribute their data to the TBI Model System national database. The objective of this project is to build a repository of data that will aid future TBI patients, as well as their families and clinicians.

Researchers from across the nation conduct studies using the information housed in this database. The TBI Model System National Database is over 30 years old and houses information from over 18,000 individuals. Information collected for the database includes medical history from before the injury, as well as details of the patient’s hospital course. Researchers obtain information through medical records, a questionnaire, and a brief bedside test. Researchers also conduct follow-up phone interviews at 1, 2, 5, and every 5 years after post-injury to follow patients for life. The information collected remains confidential. This study presents a great opportunity for patients to help future patients and clinicians with minimal effort and risk to themselves.

Click here to see a list of other sites currently contributing to the TBI Model System National Database.

Principal Investigator:

Joseph T. Giacino, PhD

Study Contact:

Mario Feranil | Email: mferanil@mgb.org

The Comparing Treatment Approaches to Promote Inpatient Rehabilitation Effectiveness for Traumatic Brain Injury (CARE4TBI)

CARE4TBI project is a pragmatic, stakeholder-driven observational study which aims to: 1) standardize electronic medical record (EMR) documentation of rehabilitation therapy to allow extraction for research and operations, 2) compare the effectiveness of well-defined rehabilitation approaches to improve community participation and functional independence of patients with TBI, and 3) identify patient, provider, setting and post-discharge factors that modify the effect of therapy on key outcomes. 

Study Contact:

Jenny Zhang | Email: jzhang71@mgb.org

Partnering with Caregivers to Increase Knowledge of the Post-Acute Phase of Recovery from Severe TBI: Development and validation of the “Post-Acute Survey on Severe Disability after TBI” (PASSD-TBI)

The PASSD-TBI will provide an efficient means of obtaining long-term outcome data on persons with prolonged disorders of consciousness, identify favorable and unfavorable influences on caregiving activities and increase knowledge of caregiver burden.

We are leading a multi-center study, in collaboration with the Indiana TBIMS, TIRR TBIMS, Tampa VA Polytrauma Rehabilitation Center (PRC), Richmond VA PRC, and San Antonio VA PRC, that will develop and test the feasibility of a telephone-based structured caregiver interview, the “Post-Acute Survey on Severe Disability after TBI (PASSD-TBI).”

If the results of the pilot study are favorable, the PASSD-TBI will be nominated for inclusion in the TBIMS National Database.

Principal Investigator:

Joseph T. Giacino, PhD

Study Contact:

Mario Feranil | Email: mferanil@mgb.org

Stakeholders Perspectives on Acceptable outcomes after TBI (SPEAC TBI)

SPEAC TBI investigates what survivors of Traumatic Brain Injury (TBI), their caregivers, investigators, and clinicians consider to be successful outcomes after a TBI. The project aims to understand these perspectives to inform future research and treatment strategies, ultimately helping individuals with TBI achieve the best possible quality of life. 

Study Contact:

Harry Torp | Email: wtorp@mgb.org

Partnering with Caregivers to Increase Knowledge of the Post-Acute Phase of Recovery from Severe TBI: Development and validation of the “Post-Acute Survey on Severe Disability after TBI” (PASSD-TBI)

The REACT Project has a goal to gain a deeper understanding of why individuals with chronic traumatic brain injuries (TBIs) often experience feelings of anger and aggression in response to events in their everyday lives. This project will investigate how people with TBIs express anger and aggression patterns over a two-week period. The study will also explore the connections between these emotional reactions and various factors such as the circumstances, their personal characteristics, their assessments of real-life situations and their methods of managing their emotions.

Study Contact:

Jenny Zhang | Email: jzhang71@mgb.org

TRACK-TBI BIO

Traumatic brain injury (TBI) is a leading cause of mortality and morbidity and a strong risk factor for neurodegenerative disorders later in life.

The absence of validated biomarkers in the neurotrauma field prevents drug development, so there are no disease-modifying therapies that successfully limit the burden of TBI.

Traumatic axonal injury (TAI) underlies the most disabling consequences of TBI. Recent breakthroughs in pre-clinical models indicate that novel therapeutic interventions are effective in promoting resilience of injured axons and improving neurologic outcome after experimental TBI.

Successful translation of these therapies will require prognostic biomarkers that measure TAI in individual patients and pharmacodynamic biomarkers that measure treatment efficacy. Currently, the best biomarker for TAI is fractional anisotropy (FA) and mean diffusivity (MD) of white matter tracts, measured using diffusion tensor imaging (DTI) MRI. This technique is poorly suited for dynamic longitudinal assessments and measures the end-result of axonal degeneration, rather than earlier neurodegenerative stages. The recent ability to assay axonal proteins in peripheral blood has made it possible to assess TAI rapidly, inexpensively, and longitudinally.

Goal of TRACK-TBI BIO:

1. Clinically validate the axonal protein neurofilament light chain (NfL) as a prognostic biomarker of TAI.
2. The TRACK-TBI Biomarker Project NF-L (TRACK-TBI BIO NF-L) extends the follow-up periods for TRACK-TBI participants from 1 to 5 years. The clinical, imaging, and biomarker data already collected in these subjects will allow for the identification of risk factors, co-morbidities, and prognostic biomarkers of TBI. The extension of study follow-up will help determine negative neurological and psychological outcomes of individuals who experienced a TBI compared to healthy controls.
3. A secondary objective is to validate serum NF-L as a biomarker of traumatic axonal injury, and obtain data that will allow us to submit a Qualification Plan to the Center for Drug Evaluation and Research at FDA for qualification of serum- NF-L as a Drug Development Tool.
4. The TRACK-TBI Biomarker Project Tau/pTau (TRACK-TBI BIO Tau/PTau) aims to validate Tau and P-Tau as prognostic biomarkers for complicated mild TBI.

TRACK-TBI EPI

Post-traumatic epilepsy (PTE) is a common TBI complication, occurring in up to 20% of civilian patients and as many as 50% of military service members who suffer severe brain trauma.

Epilepsy resulting from brain trauma is difficult to control with medical therapy and accounts for 5% of patients referred to specialized epilepsy centers.

PTE can arise from TBI of any severity and through a variety of mechanisms, which may co-exist within a single patient. Epileptogenesis can result from penetrating trauma or focal contusions known as focal brain injury. Closed head injury can also produce diffuse injury, with shearing of axons and blood vessels, diffuse edema and ischemia, and secondary cellular damage through the release of inflammatory mediators.

The clinical features of epilepsy such as seizure frequency and severity, prevalence of associated co-morbidities, and responsiveness to therapy, may differ. Additionally, there is variation in neurophysiologic and imaging features of epileptogenicity. Indeed, a sophisticated understanding of the subtypes of epilepsy resulting from brain trauma is required to successfully develop anti-epileptogenic therapies.

Goal of TBI-TRACK EPI:

Determine how PTE contributes to negative neurological and psychological outcomes of individuals who experienced a TBI through comparisons to patients with TBI but without PTE.

Funded in March 2019, TRACK-TBI Epileptogenesis Project (TRACK-TBI EPI) extends the follow-up period of the TRACK-TBI cohort up to 5 years after injury to identify patients who developed PTE. The TRACK-TBI NINDS PTE Screening Questionnaire identifies participants who screen positive for PTE and consent them to undergo a detailed clinical evaluation. Data collected via a combination of follow up phone screening and in-person visits assesses the relationship between TBI severity and epileptogenesis as the primary endpoint. These data will provide the first comprehensive longitudinal phenotyping of subjects with PTE from the moment of TBI through their epilepsy diagnosis and treatment.

TRACK-TBI LONG

RACK-TBI LONG, launched in May 2019, extends follow-up of the deeply phenotyped TRACK-TBI cohort into the chronic phase.

This is the first and largest study of incident TBI to couple comprehensive multi-year clinical trajectories with advanced neuroimaging and proteomic biomarkers.​

Goal of TBI-TRACK LONG:

1. Connect with participants enrolled in the TRACK-TBI-II study to assess their functional status two or more years after their original study injury.
2. Elucidate TBI’s natural history.
3. Identify individuals most at risk for unfavorable outcomes.
4. Initiate development of diagnostic, prognostic, and therapeutic/ management tools for this heterogeneous condition.

TRACK-TBI LONG expands upon the original TRACK-TBI study protocol. TBI and Control participants from the TRACK-TBI U01 study as well as participants enrolled under the Post-U01 phase of the study will be eligible for up to 3 annual TRACK-TBI LONG Telephone Assessments.

TRACK-TBI LONG is supported by funding through a competitive grant from the National Football League Scientific Advisory Board and the National Institute of Neurological Disorders and Stroke (Post-UO1 participants).

Disorders of Consciousness Practice Guideline Knowledge Translation (KT) Project

This five-year National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)-funded study, led by Joseph T. Giacino, PhD, from Spaulding Rehabilitation Hospital and Harvard Medical School, and supported by the Curing Coma Campaign, aims to evaluate the awareness, beliefs, and adoption of the 2018 evidence-based practice guidelines for the clinical management of individuals with acquired disorders of consciousness (DoC). These guidelines were sponsored by the American Academy of Neurology (AAN), the American Congress of Rehabilitation Medicine (ACRM), and NIDILRR.

Aims

1. Characterize provider awareness, attitudes, perceptions of contextual determinants and use of the DoC practice guidelines for diagnosis and prognosis among providers who care for persons with DoC.
2. Develop and assess the acceptability, appropriateness and feasibility of DoC guideline KT interventions customized to setting-specific contextual determinants to promote their use.
3. Obtain preliminary data on the acceptability, use and sustainability of customized DoC guideline KT strategies and tools among providers in diverse real-world clinical settings.

DoC Resources

Disorders of Consciousness Guidelines:

https://www.aan.com/Guidelines/Home/GuidelineDetail/926

Full-Length Version: 

https://www.aan.com/Guidelines/Home/GetGuidelineContent/928

Spaulding Research Institute for Brain Injury and Concussion Recovery partnered with actress Emilia Clarke’s foundation SameYou to improve the quality of care patients receive following neurological trauma.

Thanks to SameYou’s vision and incredible generosity, we are launching a groundbreaking research study, the I RISE Research Project, to better understand the brain’s “resilience” both before and after an acquired brain injury- such as those caused by stroke, head trauma, and illness.