Applications to the FY23 SCIRP Clinical Trial Award (CTA) must address at least one of the Focus Areas listed below. Applications may address more than one Focus Area. In particular, applications combining biomarker studies with studies in one or more of the other Focus Areas are encouraged. Applications using clinically relevant combinations of interventions within or across Focus Areas are also encouraged. The FY23 SCIRP Focus Areas are:
• Preserving and protecting spinal cord tissue at time of injury for improved neurologic outcomes ○ Responsive projects may include surgical and acute care management of SCI. ○ Therapeutics (devices and pharmacologic interventions) to stabilize SCI in the prehospital environment and during transport are encouraged. ○ Applications proposing neuroprotective interventions need to demonstrate a clinically feasible window for treatment and more than an incremental improvement over existing therapies.
• Identifying and validating biomarkers for diagnosis, prognosis, and evaluation of treatment efficacies ○ Biomarkers must focus on diagnosis, prognosis, progression, and/or recovery of SCI. ○ Projects with a clear link between a biomarker and underlying physiology are encouraged. Projects can include imaging and other modalities. ○ Applications should demonstrate a clear path to clinical use. ○ Biomarker studies directed at identifying the best single or combination of treatments for individuals (personalized medicine) are encouraged.
• Developing, testing, and validating promising interventions to address bowel, genitourinary, neuropathic pain, cardiopulmonary, or autonomic dysfunction in people with SCI ○ Mechanism-focused studies must be specific to SCI and demonstrate a clear path from increased understanding to advancing treatments. ○ Studies addressing the needs of and treatments for individuals with SCI across the full lifespan from acute to chronic injury are encouraged.
• Investigating psychosocial issues relevant to people with SCI, their families, and/or their care partners ○ Applications should directly address, or show clear relevance to, the needs of Service Members and Veterans. ○ To be responsive to this Focus Area, psychosocial issues must be the primary focus of the research. ○ Projects should provide an understanding of critical factors promoting psychosocial wellbeing leading to implementation of potential treatments and interventions. ○ Studies addressing social isolation, loneliness, and depression, as well as resilience, selfefficacy, sexuality and intimacy, and interactions between people living with SCI and their care partners, are especially encouraged.
• Rehabilitation and regeneration—maximizing the function of the residual neural circuitry, including harnessing neuroplasticity and recovery to improve function after SCI ○ Studies that address critical questions of dosing, targeting, or safety required to move the research toward clinical use are supported. ○ Applications studying mechanisms of regeneration or identifying novel therapeutic targets must include a feasible projected pathway for translation and clinical implementation. ○ Basic research projects designed to understand general mechanisms underlying axonal sprouting, regeneration, or neuroplasticity are discouraged unless they directly address translatable approaches.