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Congressionally Directed Medical Research Programs -- Psychological Health/Traumatic Brain Injury Research Program -- Complex Traumatic Brain Injury Rehabilitation Research Clinical Trial Award
The FY17/18 PH/TBIRP Complex TBI Rehabilitation Research – Clinical Trial Award (CTRR-CTA) is intended to support clinical trials focused on TBI rehabilitation interventions in the areas of cognitive and vestibular rehabilitation. Research focusing on rehabilitation strategies in patients with mild TBI is highly encouraged.
• Pre-Application Deadline: October 11, 2017
• Invitation to Submit an Application: November 10, 2017
• Application Submission Deadline: December 27, 2017
Areas of Interest
The FY17/18 PH/TBIRP CTRR–CTA seeks research focused on potential interventions relevant to the mission of the JPC-8/CRMRP. To meet the intent of the award mechanism, applications must be responsive to one or both of the following two FY17/18 PH/TBIRP CTRR–CTA Focus Areas:
1. Cognitive Rehabilitation: Cognitive rehabilitation-focused clinical trials should generate new knowledge to confirm whether novel or standard-of-care rehabilitation interventions are effective in remediating cognitive impairments (e.g., memory, processing speed, executive functioning) and functional limitations after TBI. Applications specifically addressing barriers to participation in Service members with TBI are strongly encouraged. Investigators are encouraged to pursue pragmatic trial designs that compare both novel and standard-ofcare cognitive rehabilitation practices, include diverse (but militarily relevant) populations of study participants, recruit patients from heterogeneous practice settings (e.g., Department of Defense [DoD] and VA), and collect data across a broad range of functioning including standard-of-care DoD outcome measures. Applications are encouraged to address one or more of the following elements: optimal cognitive rehabilitation prescription patterns (to include frequency, intensity, time, and type); optimization of combination therapies to produce synergistic treatment effects across multiple domains (e.g., cognition and pain); identification of patient characteristics presumed to affect outcomes and/or effectiveness of therapies.
2. Vestibular Rehabilitation and Mechanisms of Recovery: Vestibular rehabilitationfocused clinical trials should generate new knowledge to remediate symptoms (e.g., dizziness, vertigo, motion intolerance), impairments (e.g., gaze, postural and dynamic instability), functional limitations, and barriers to participation (e.g., readiness to return to duty) associated with post-traumatic dizziness and/or vestibular pathology in patients with TBI. Applications should include a plan to collect data across a broad range of functional outcomes including standard-of-care DoD outcome measures. Applications are encouraged to include one or more aims that objectively characterize neurologic mechanisms of recovery associated with novel and/or standard-of-care vestibular rehabilitation interventions; include data obtained in a sample of active duty military personnel, and advance understanding of rehabilitation prescription (to include frequency, intensity, time, and type of therapeutic exercise).
Independent investigators at all academic levels (or equivalent) are eligible to submit an application.
The anticipated total costs budgeted for the entire period of performance for an FY17/18 PH/TBIRP CTRR–CTA will not exceed $2.5 Million (M) for awards responding to the Vestibular Rehabilitation and Mechanisms of Recovery Focus Area or $4.0M for awards responding to the Cognitive Rehabilitation Focus Area. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.