# Novel Stimulation to Improve Respiratory Function in ARDS and Severe COVID-19 Patients

> **NIH NIH R43** · RESTORE TECHNOLOGIES, INC. · 2022 · $275,405

## Abstract

PROJECT SUMMARY/ABSTRACT
Acute respiratory distress syndrome (ARDS) is an often-fatal form of respiratory failure. Relevant to the recent
coronavirus pandemic, the majority of patients with severe Coronavirus Disease of 2019 (COVID-19) develop
ARDS and need mechanical ventilation and ICU admission, placing severe strains on the medical system. Use
of mechanical ventilation (MV) during ARDS for cases such as COVID-19 is supportive until the infection has
resolved which may take up to 20 days. While MV is useful for ventilation and supporting life, it causes severe
atrophy of respiratory muscles that delays extubation. Furthermore, prolonged MV causes substantial morbidity
and mortality (i.e. lung injury, pneumonia, laryngeal injury, etc.) Therefore, strategies to condition the respiratory
muscles to prevent atrophy during intubation will likely decrease MV time, thereby decrease morbidity and
mortality associated with MV, and decrease ventilator need and consumption of valuable resources.
Strategies have been developed to condition or activate the diaphragm muscle during chronic high cervical spinal
cord injury with implants that stimulate the phrenic nerve or diaphragm; however, such an invasive strategy is
incompatible with the acute and temporary nature of ARDS. The main hurdle to accessing the neural network
for breathing for therapeutic purposes is that the neural mechanisms controlling respiration reside deep in the
brainstem, which is dangerous to access surgically. Recently, we elucidated a novel breathing pathway that can
be modulated by stimulation of the spinal cord. We have compiled significant data demonstrating that this
strategy can restore or augment breathing. The main objective of this project is to provide safety and feasibility
data for this approach in patients with ARDS. The second objective is to provide proof of the concept that this
strategy can improve respiratory function in ventilator-dependent patients and define the stimulation parameters
that most effectively prevent respiratory muscle atrophy during MV. The deliverables for this project include
establishing the safety and feasibility of transcutaneous spinal stimulation for respiratory rehabilitation in ARDS,
preliminary efficacy data, refining the prototype design, and creating support for subsequent phases of device
development.

## Key facts

- **NIH application ID:** 10483910
- **Project number:** 1R43HL162180-01A1
- **Recipient organization:** RESTORE TECHNOLOGIES, INC.
- **Principal Investigator:** Bill Hardin
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $275,405
- **Award type:** 1
- **Project period:** 2022-06-01 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10483910

## Citation

> US National Institutes of Health, RePORTER application 10483910, Novel Stimulation to Improve Respiratory Function in ARDS and Severe COVID-19 Patients (1R43HL162180-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10483910. Licensed CC0.

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