# Restoration of Grasp and Reach in Cervical Spinal Cord Injury

> **NIH NIH UH3** · CASE WESTERN RESERVE UNIVERSITY · 2024 · $1,970,521

## Abstract

The proposed work is focused on restoration of hand and reaching functions for people
with cervical level spinal cord injury. For individuals who have sustained this injury, restoration
of hand function is their top priority, and existing alternatives are limited. Neuroprostheses are
the most promising method for significant gain in hand and arm function.
In this CREATE project, we propose to prepare for a future pivotal clinical trial by
transfer of a third-generation neuroprosthetic, the Networked Neuroprosthesis, to two clinical
trial sites. The effort will enable the development and evaluation of a clinical training program,
establish the effectiveness of device transferability, and bring valuable clinical and patient
experience into the product development cycle. The work represents an interim step between
our Early Feasibility IDE experience which is currently underway, and a future Pivotal Clinical
Trial.
In the first phase of the proposed work, we will harden the implantable system for
manufacture, and complete the verification and validation that will be necessary to perform a
pivotal clinical trial. In the second phase, we will extend our Early Feasibility study by selecting
and training two beta sites to test the feasibility of our training materials and procedures, our
technology and medical/surgical procedures of implementation, and our outcome evaluations, in
order to establish our system’s readiness for further translation to a Pivotal Clinical Trial.
Following this work, our intent would be to undertake further expansion of the study to a Pivotal
Clinical Trial in order to collect the definitive dataset necessary for full regulatory approval and
market release that would enable successful commercialization and broader access for people
with spinal cord injuries. This effort is coupled with an overall strategy for sustainable
dissemination of this technology to the SCI population. Thus, the impact from this study is not
only to demonstrate the benefits of a single clinical application, but the impact also extends to
the entire field of SCI and similar orphan diseases through the establishment of a sustainable
entity that can assure the availability of implanted neuroprostheses to the individuals who can
benefit from them.

## Key facts

- **NIH application ID:** 10909325
- **Project number:** 5UH3NS103863-05
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Anne Bryden
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,970,521
- **Award type:** 5
- **Project period:** 2018-03-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10909325

## Citation

> US National Institutes of Health, RePORTER application 10909325, Restoration of Grasp and Reach in Cervical Spinal Cord Injury (5UH3NS103863-05). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10909325. Licensed CC0.

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