DoD Clinical and Rehabilitative Medicine Assistive Technologies Research Award | Apply Online

Opportunity Summary:

The DoD Clinical and Rehabilitative Medicine Assistive Technologies Research Award (ATRA), offered under the Defense Medical Research and Development Program (DMRDP) by the U.S. Army Medical Research Acquisition Activity (USAMRAA), is a clinical-trial-focused funding opportunity aimed at speeding the real-world use of new assistive technologies that can restore or meaningfully improve vision, hearing, and/or balance after traumatic injury. The program is specifically centered on restorative and rehabilitative technologies that provide sensory substitution or sensory augmentation, meaning devices or related interventions that help patients regain function by replacing or enhancing impaired sensory inputs. The overall intent is practical and translational: generate credible human evidence of safety and effectiveness so promising technologies can move faster into broader clinical use for Service Members, Veterans, and ultimately the wider public.

A key requirement is that every funded project must be a clinical trial in humans, not preclinical development. The announcement defines a clinical trial as the prospective enrollment of human participants where an intervention is tested to produce measurable outcomes related to safety, effectiveness, efficacy, or other exploratory endpoints. The trial can span a range of maturity, from proof-of-concept and first-in-human studies through Phase II clinical trials, and it can involve Class I, II, or III medical device trials and testing. What it cannot involve is drugs or biologics; those categories are explicitly excluded. Each application is expected to propose one distinct clinical trial with a clear study design rather than a bundle of multiple studies.

Although the research must be clearly tied to military needs, applicants are not required to recruit military populations. Instead, proposals must explicitly explain military relevance by connecting the clinical problem and the anticipated benefit to the health care needs of Service Members and Veterans who experience serious visual, auditory, and vestibular (balance-related) impairments due to trauma. The proposed work should be designed to demonstrate effectiveness while further evaluating safety in human patients with debilitating sensory injuries, with the larger goal of accelerating translation to improved clinical capabilities.

Regulatory readiness is treated as a central part of feasibility. If the clinical study uses an investigational device that is not already FDA-approved for the intended investigational use, the project may need to comply with FDA Investigational Device Exemption (IDE) requirements. The application must provide evidence that an IDE has been submitted or will be submitted within 60 days after the award date, or that the device is IDE-exempt. The government also makes clear that it can withdraw funding if a required IDE is not obtained within six months of the award date, which effectively means applicants need a realistic, well-supported regulatory plan before the project begins.

The solicitation highlights several practical expectations that applicants must address in detail. Trials are expected to start within 12 months of the award date, so timelines need to be credible and implementation-ready. Preliminary data relevant to the proposed trial is required, reflecting that the program is supporting advancement of technologies that already have a foundation of evidence. Proposals must be grounded in a sound scientific rationale supported by literature analysis and logical reasoning, and they must show that the investigators can actually execute the trial as proposed. That includes demonstrating access to an appropriate patient population, explaining how recruitment and enrollment targets will be met, and discussing how existing standards of care could affect enrollment or outcomes. Similarly, the application must document access to the technology or device needed for the study so that device availability is not a bottleneck.

From a study quality perspective, the program expects clearly defined endpoints, a well-developed statistical analysis plan, appropriate statistical expertise, and a power analysis that justifies sample size in a way that can credibly answer the trial objectives. Operationally, applicants are expected to include a study coordinator (or coordinators) who can manage Institutional Review Board (IRB) and other regulatory approvals, coordinate across multiple sites if relevant, and drive participant accrual and overall trial logistics. Beyond the trial itself, the application should include a Transition Plan describing how the product will move to the next phase of clinical testing and/or toward commercialization or broader delivery after the award, including likely funding sources and resources needed. The announcement also emphasizes documented institutional support, signaling that the host organization should be clearly committed to enabling the trial.

In terms of award structure and basic program facts, the opportunity (Funding Opportunity Number W81XWH-13-DMRDP-ATRA) was posted November 30, 2012, with an original and current closing date of March 13, 2013, and an archive date of April 12, 2013. It anticipated about three awards with an estimated total funding level of $6,000,000. The funding instrument is listed as a cooperative agreement and grant, under CFDA 12.420 (Military Medical Research and Development). There is no cost sharing or matching requirement, and eligibility is described as unrestricted, meaning a wide range of entity types can apply as long as they meet any additional conditions stated in the full announcement.

Overall, this award is best understood as a mechanism for teams that already have a credible assistive technology concept and supporting preliminary evidence, and are ready to run a well-designed, properly powered human clinical trial with a clear regulatory path, a workable recruitment plan, and a concrete strategy for what happens after the trial ends.

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