Agency: DoD Congressionally Directed Medical Research Programs
Funding Opportunity Title: Complex Traumatic Brain Injury Rehabilitation Research Award
Funding Opportunity Number: W81XWH-16-PHTBIRP-CTRRA
Preproposal Deadline: August 17, 2016
Invited Full Proposal Deadline: November 30, 2016
Summary:
The FY16 PH/TBIRP Complex TBI Rehabilitation Research Award (CTRRA) is intended to support observational studies and clinical trials addressing rehabilitation of patients with complex TBI. TBI is defined as being caused by (1) a direct blow or impact to the head, (2) a penetrating head injury, or (3) an exposure to external forces such as blast waves that disrupt the function of the brain. Not all blows to the head or exposure to external forces result in a TBI. The severity of TBI may range from “mild” — a brief change in mental status or consciousness — to “severe,” an extended period of unconsciousness or confusion after the injury. All applications to the FY16 PH/TBIRP CTRRA must be relevant to complex TBI, defined by a diagnosed TBI in conjunction with symptoms identified in one or more of the following JPC-8/CRMRP Focus Areas:
• The Sensory Systems Traumatic Injury Focus Area involves visual, auditory, and vestibular dysfunction associated with traumatic injury.
• The Pain Management Focus Area is concerned with chronic pain, acute pain in the context of chronic pain, and establishing safety margins for prescriptions, as well as developing strategies to help patients cope with pain.
• The Neuromusculoskeletal Injury Rehabilitation Focus Area deals with amputee care, spinal cord injuries, burns and contractures, and orthopaedic injuries, as well as developing guidelines for standards of care.
In addition, research in the areas described below is very highly encouraged. Patients with complex TBI demonstrate symptoms including, but not limited to, dizziness, visual dysfunction, headaches, and cognitive deficits that are refractory to treatment (i.e., slow/non-response to current treatment regiment, relapsing symptoms following treatment). The FY16 PH/TBIRP CTRRA seeks research on the affected patient populations, mechanisms of comorbidities and potential interventions in the following three Areas of Encouragement:
• Epidemiological studies to define differences between populations of patients with complex TBI whose symptoms are non-responsive as compared to responsive to treatment. (Observational studies only; clinical trials are not supported for this Area of Encouragement. See the definition of a clinical trial and observational studies on
• Etiological studies to identify factors that contribute to differences between patients with complex TBI who respond to treatment and those who do not, with the goal of identifying mechanisms underlying refractory symptoms. (Observational studies only; clinical trials are not supported for this Area of Encouragement. See the definition of a clinical trial and observational studies on page 7 of this Program Announcement/ Funding Opportunity.)
• Interventional studies to evaluate emerging or existing rehabilitation strategies for the treatment of patients with complex TBI compared to existing standards of care. Proposed studies evaluating interventions for patients with TBI and comorbidities that may be refractory to treatment are of particular interest. (Both observational studies and clinical trials are allowed for this Area of Encouragement.)
Additionally, other studies of complex TBI may be considered if they address important issues relevant to the identified JPC-8/CRMRP Focus Areas in the context of TBI if sufficient justification is included in the appropriate sections of the pre-application and application.
Military Relevance: Relevance to the healthcare needs of military Service members, Veterans, and beneficiaries is a key feature of this award. Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate military relevance:
• Explanation of how the project addresses an aspect of the target disease/condition/ technology that has direct relevance to military Service members, Veterans, and/or other military health system beneficiaries
• Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to benefit the civilian population and also address a military need
• Use of military or Veteran populations or datasets in the proposed research
Award Information
The FY16 PH/TBIRP CTRRA is intended to support both observational studies and clinical trials addressing TBI and co-occurring clinical presentations (neuromusculoskeletal injuries, multisensory dysfunction, and pain) that are often slow/nonresponsive to treatment. The intent of the award is to advance the evidence-based practice for the treatment of TBI with JPC-8/CRMRP-relevant comorbidities by improving understanding of the composition and problems of this population and developing and evaluating treatments.
Applications for this award mechanism may propose epidemiological, etiological, and/or interventional studies (see CTRRA Areas of Encouragement on page 4).
Preclinical studies and studies using animals are not supported by this Program Announcement/Funding Opportunity.
Two different funding levels, based on the type of study proposed, are available under this Program Announcement/Funding Opportunity. It is the responsibility of the PI to select the funding level that is most appropriate for the research proposed based on the following descriptions.
The following, although not all-inclusive, are research projects that would be appropriate to propose under each funding level:
• Funding Level 1: For epidemiological and etiological studies comparing patients with complex TBI responsive versus refractory to treatments. PIs should describe a reproducible methodological approach that will identify or define factors that are associated with slow/non-response to treatment, or relapse of symptoms for patients with complex TBI. Observational studies, but not clinical trials, are permitted at this Funding Level.
• Funding Level 2: For interventional studies to evaluate emerging or existing treatment and rehabilitation strategies. PIs should explain how their work will inform the development, refinement, and/or revision of existing standards of care, clinical recommendations, or guidelines. Both observational studies and clinical trials are permitted at this Funding Level.
Both observational studies and clinical trials, but not preclinical research studies, are allowed in the FY16 PH/TBIRP CTRRA. Observational studies and clinical trials have different submission requirements and it is the responsibility of the PI to correctly identify the type of research proposed and to comply with the relevant submission requirements. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. An observational study is a type of clinical study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given). These types of studies are not considered clinical trials. All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of research.
References:
Program Solicitation
