Resource Facilitation: Indiana Best Practices Manual for Return-to- Work or Return-to-School Click on the read more button to get a link to download the full manual. Once you… Read More
Multicenter Evaluation of Memory Remediation after TBI with Donepezil (MEMRI-TBI-D Study) March 10, 2015 Flora Hammond, MD (PI); Funded by National Institute on Disability and Rehabilitation Research (NIDRR). This study… Read More
New RHI Research Study, seeking participants: Lifestyle Management in Spinal Cord Injury: This pilot study is modeled on a successful lifestyle change program conducted at the University of Pittsburgh. Based… Read More
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FOR IMMEDIATE RELEASE October 24, 2014 CONTACT: Stephanie S. Hale, BAA, Marketing Public Relations and Marketing Off.: 317-329-2093 Cell: 317-626-2910 firstname.lastname@example.org Flora M. Hammond, M.D.… Read More
Flora Hammond, MD (PI), James Malec, PhD (Co-PI), Jacob Kean, PhD, Susan Perkins, PhD, Patrick Monahan, PhD, funded by National Institute on Disability and Rehabilitation Research (NIDRR).
An estimated 1.56 million Americans sustain a TBI requiring medical attention each year. A TBI is defined as damage to the brain caused by an external force as evidenced by altered consciousness and impairment of brain functioning. After the initial medical crisis, TBI presents significant challenges to the individual, family, and society. An injured person may experience a wide range of physical, cognitive, emotional and behavioral changes that affect their ability to function. Financial hardship, substance abuse, anxiety and depression are some of the common problems experienced by individuals following a TBI.
The TBIMS NDB is a multi-center, prospective, longitudinal study that will be used for descriptive analyses of outcome, correlation of injury severity and pre-morbid characteristics to outcomes, and for monitoring trends over time. The primary aim of the TBIMS NDB is to provide data for research to improve care and outcomes for individuals with TBI.
Currently, there are 16 TBIMS centers, each providing a multidisciplinary system of rehabilitation care, including emergency medical, acute medical, and post-acute services. In addition to providing direct services, these centers play a pivotal role in building the national capacity for high-quality treatment and research serving persons with TBI, their families and the communities in which they reside.
-Study 1: “Buspirone for the Treatment of Chronic Post-TBI Irritability and Aggression: A 91-Day Single- Site, Flexible-Dose, Parallel Group, Randomized, Placebo-Controlled Trial”
-Study 2: “Preliminary Development of the Aggression and Irritability Impact Measure”
It is anticipated that 74 subjects with 74 corresponding subject observers will be recruited for the treatment arm. Not all individuals screened for the treatment arm will qualify for inclusion in the treatment arm; however, almost all individuals screened should qualify for inclusion in the Measurement arm. Since screening more than the 150 individuals will be required for the treatment arm, this method of recruitment to the treatment arm should ensure that we have a sample large enough to generate an adequate range of scores for measurement development.
Subjects will be recruited from community and self-referrals from sources that include local brain injury clinics, psychologists, therapists, local healthcare providers, support groups, BIA-IN, physician letters to patients, flyers posted in clinics, handouts for clinic nurses and physicians, newsletters, hospital, medical school, and Indiana CTSI web sites, Craigslist.org, local and regional presentations. Recruitment may occur at the following sites: RHI and IUH hospitals and clinics, community agencies, and support groups. Clinicians will introduce the study to their patients whom they feel may be appropriate and provide them with the information needed to contact the research staff to learn more about the study. Interested potential participants will be scheduled for an in-person screening visit.
Subjects who consent and qualify will be randomized in a 1:1 ratio, buspirone or placebo. Stratification to randomization group will occur based on the presence of major or minor depression (defined by PHQ-9 total score >5). Randomized subjects will receive active treatment or placebo regardless of depression status. There will be 4 clinic visits. Visits will occur at baseline, for consenting and screening, day 35, day 63 and day 91. At all 4 clinic visits, both the subject and the observer will be given questionnaires regarding the subject’s behavior and mood. Follow up phone calls will occur each week that the subject is not seen in the clinic until the end of the study. Follow up phone calls will assess for study medication compliance, adverse events and concomitant medication changes. Day 91 ends the period of the Randomized Clinical Trial phase of the study and the subjects will begin the 1 month continuation phase of the study when all participants receive active buspirone.
The following questionnaires will be used as measures of irritability and aggression for the subject and the observer: Neuropsychiatric Inventory (NPI & NPI-Distress), Aggression & Irritability Impact Measure (AIIM) and Global Impression of Change.
The following questionnaires will be dispensed to the subject only: TBI-Quality of Life-Anger, Personal Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), PTSD Checklist Civilian (PCL-C), and Glasgow Outcome Scale Extended (GOS-E) The Investigator will complete the Clinical Global Impression of change at Visits 1, 2, 3, and 4. History and Physical Exam, creatinine level (kidney function) and liver function tests will be obtained for eligibility. Serum pregnancy tests will be drawn at screening for females of childbearing potential.
Contact Person: Becky Runkel at email@example.com or 317-329-2217