# Multi-Center Clinical Trial of Spinal Cord Stimulation to Restore Cough

> **NIH NIH UG3** · CASE WESTERN RESERVE UNIVERSITY · 2022 · $1,608,519

## Abstract

Respiratory complications account for significant morbidity and mortality in persons with cervical and high
thoracic spinal cord injury (SCI) due to their inability to cough. As a consequence, most individuals suffer from a
markedly reduced ability to clear airway secretions resulting in the development of recurrent respiratory tract
infections.1-16, 128-130,132,135,136 Moreover, diseases of the respiratory system are the leading cause of death in this
patient population.3,7,9,12,15 These individuals lack an effective cough mechanism due to paralysis of the muscles
of expiration.18-20,42,126-130,132,135,136 We have performed a pilot clinical trial (n=17) with disc electrodes and
demonstrated that an effective cough can be restored in SCI.27-29 This method results in near maximal expiratory
muscle activation, as reflected by the generation of large airway pressures and peak expiratory airflow rates,
which are in the same range as those observed during maximum cough efforts in normal persons.27,28 Use of the
system significantly reduces the difficulty in raising secretions and reduces the incidence of respiratory tract
infections29,117 Unfortunately, disc electrode placement requires an invasive surgical procedure. In a recent
clinical trial of bipolar SCS with parallel wire electrodes (T9–T11 spinal levels), we demonstrated that comparable
levels of expiratory muscle activation and clinical benefits can be achieved, when compared to the disc
electrodes (n=12).119,120,121a,153 Our current stimulation system entails use of wire electrodes manufactured by
Ardiem (Indiana, PA) and electrical stimulator by Finetech, Inc (London, England) (FM). FM however does not
have Bluetooth capability, has a cumbersome antenna and does not have a license to allow US
commercialization. Therefore, we plan to partner with Avery Biomedical Devices (Commack, NY) (ABD) to
construct more advanced and more user-friendly stimulator. The ABD device will have Bluetooth capability
allowing for remote activation and facilitate data logging including the ability to view, download and analyze data
in real time and the antenna is very flexible with no orientation requirement. In addition, ABD already services
patients with respiratory care needs. This stimulator will be used in conjunction with Ardiem wire electrodes,
utilized in our recent clinical trial. This device will represent the only commercially available spinal cord stimulator
with the range of stimulus parameters required to activate the expiratory muscles and restore an effective cough.
The Major Objectives of the proposed study, therefore, are to 1) construct an electrical stimulator to activate
the expiratory muscles and connect with the Ardiem electrodes 2) perform the necessary testing required by the
FDA to amend our current IDE 3) perform a multi-center clinical trial to determine the utility of SCS with wire
leads to produce an effective cough and provide an effective means of clearing airway secretions, reduce ...

## Key facts

- **NIH application ID:** 10358346
- **Project number:** 1UG3NS121560-01A1
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Anthony F. DiMarco
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,608,519
- **Award type:** 1
- **Project period:** 2022-09-22 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10358346

## Citation

> US National Institutes of Health, RePORTER application 10358346, Multi-Center Clinical Trial of Spinal Cord Stimulation to Restore Cough (1UG3NS121560-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10358346. Licensed CC0.

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