The idea could prove transformative for hundreds of thousands of people living with spinal cord injuries (SCI). CERSE researchers developed a non-invasive procedure, applying a stimulator in combination with an exoskeleton to help people with SCI walk.
Five participants volunteered and were on the waitlist, ready to go as soon as the project received approval and funding. But the researchers found themselves bogged down in resource requirements from the Food and Drug Administration (FDA) and the Institutional Review Board and resource requirements. That’s when they called on CERSE.
CERSE provided a highly experienced research coordinator who worked out the procedures, addressed review board issues and obtained review board approvals in three months. The team was able to link the researchers to a foundation, which paid for FDA-required device testing. CERSE also:
- Helped complete the FDA application, which led to FDA approval for the experimental use of the device.
- Worked with VCU to create a faculty position so the project could better utilize VCU’s CERSE resources.
- Supported the submission of several grant applications through the Hunter Holmes McGuire Veterans Affairs Medical Center (VAMC) and the university.
- Helped the researchers fast-track an agreement to receive five industry donated stimulators. Within four months, the project received more than $4 million in funding from the VA Rehabilitation Research and Development Service (RRDS) and the Department of Defense.
Soon, the intervention will help people walk.