Due to the current Continuing Resolution, the FY17 Defense Appropriations bill has not been passed. Although funds have not been appropriated for the Department of Defense Psychological Health/Traumatic Brain Injury Research Program (PH/TBIRP), the PH/TBIRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY17 funding opportunities.

FY17 PH/TBIRP Program Announcements and General Application Instructions for the following award mechanisms being released on behalf of the Joint Program Committee 8/Clinical and Rehabilitative Medicine Research Program are anticipated to be posted on Grants.gov in March 2017. Pre-application and application deadlines will be available when the Program Announcements are released. This pre-announcement should not be construed as an obligation by the Government, and funding of research projects received in response to these Program Announcements is contingent on the availability of Federal funds appropriated for the PH/TBIRP.

As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency’s J9 Research and Development Directorate manages the Defense Health Program’s Research, Development, Test, and Evaluation appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the U.S. Army Medical Research and Materiel Command Congressionally Directed Medical Research Programs (CDMRP).

FY17 Complex Traumatic Brain Injury (TBI) Rehabilitation Research Focus Areas. The FY17 PH/TBIRP will solicit research applications for the following focus areas:

1. Develop, evaluate, and/or validate Return to Duty outcomes following rehabilitation in patients with TBI. Develop ecologically valid (e.g., military-specific tasks) and clinically practical standardized functional outcome measures for Service Members with TBI that inform return to duty/participation. Outcome measures should address the impact on function- and participation-level performance of specific cognitive deficits (e.g., processing, attention, memory) and/or sensorimotor dysfunction.
2. Develop and/or evaluate treatment strategies (e.g., multitask/dual-task, sequential vs. parallel, etc.) for TBI sequela including, but not limited to, pain, cognitive deficits (attention, memory, etc.), exertion-induced symptoms, and dizziness. Intervention strategies should aim to increase patient tolerance for rehabilitation and result in measurable improvement in targeted impairments and function- and participation-level performance.
3. Evaluate the effectiveness of clinically feasible rehabilitation technologies for the objective assessment and/or treatment of cognitive deficits and/or sensory or sensorimotor dysfunction in Service members with TBI with the intent to inform return to duty/participation decisions.
4. For patients with TBI-associated cognitive deficits or sensory or sensorimotor dysfunction(s):
   1. Investigate the delivery of rehabilitation interventions with regard to optimization of treatment prescription (i.e., frequency, intensity, timing, and type).
   2. Investigate the comparative effectiveness of interventions resulting in measurable improvement in targeted impairment and functional- and participation-level performance.
5. Understand the neural mechanisms of recovery and/or natural progression following isolated or cumulative TBIs in Service Members. Investigators should explore one of the following:
   1. Cognitive Deficits – to inform novel rehabilitation interventions that drive neuroplasticity and lead to the recovery of cognitive function.
   2. Sensory or Sensorimotor Dysfunction – to inform novel rehabilitation interventions that lead to recovery of sensory or sensorimotor function.
   3. Chronification of Pain – to inform knowledge of and treatment for the progression from acute to chronic pain in TBI-associated headache/migraine.

Complex TBI Rehabilitation Research – Technology/Therapeutic Development Award

Independent investigators at all academic levels (or equivalent) are eligible to submit an application

• Supports observational studies, clinical mechanistic studies, and/or clinical trials that are small, pilot, and exploratory in nature.
• Must address one or more FY17 Focus Areas.
• Preclinical studies using animals are not supported.
• Preproposal submission is required; application submission is by invitation only.

Funding Level 1: Observational Research Studies

• Supports observational research studies with no intervention(s). Reproducible methodological approaches involving human subjects that address one or more Focus Areas should be described. Clinical trials are not permitted at this funding level.

Funding Level 2: Clinical Translational Research Studies

• Supports clinical studies with deliberate manipulation of stimuli to probe physiologic responses with the intent to explore/explain underlying mechanisms or novel rehabilitation treatment strategies. Any clinical trials proposed for this award mechanism should be pilot or exploratory in nature.

Funding Level 1:

• Maximum funding of $750,000 for total costs (direct plus indirect costs).
• Maximum period of performance is 3 years.

Funding Level 2:

• Maximum funding of $2.5 million (M) for total costs (direct plus indirect costs).
• Maximum period of performance is 4 years

Complex TBI Rehabilitation Research – Clinical Trial Award

Independent investigators at all academic levels (or equivalent) are eligible to submit an application.

• Focuses on understanding the etiology, epidemiology, and natural history of TBI, with the goal of improving clinical understanding of rehabilitation-relevant physiologic mechanisms; developing and validating rehabilitation outcomes or treatment strategies for management of TBI; and management of TBI-related sequelae.
• Supports clinical trials to advance evidence-based practice for treatment of TBI with pain, sensory, sensorimotor, and/or cognitive comorbidities by improving understanding of the composition and problems of this population and developing and evaluating treatments.
• Clinical trials are required. Clinical trials, including alternative study designs such as Practice-Based Evidence, will be considered in this category.
• Preproposal is required; application submission is by invitation only.

• Maximum funding of $5M for total costs (direct plus indirect costs).
• Maximum period of performance is 4 years.

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Applications must be submitted through the federal government’s single-entry portal, Grants.gov. Submission deadlines are not available until the Program Announcements are released. For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the PH/TBIRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil