# Closed Loop Electrical Muscle Stimulation System (CL-EMS) with improved safety for ICU environment to mitigate ICU Acquired Weakness

> **NIH NIH R44** · HEALTH DISCOVERY LABS LLC · 2024 · $874,061

## Abstract

Project Summary/Abstract
The goal of the project is to develop a closed loop electrical muscle stimulation (CL-EMS) system to mitigate ICU
acquired weakness (ICUAW). Multifactorial in origin (extended period of bed rest, acute inflammatory state,
exposure to multiple pharmacological agents such as neuromuscular blockers, antibiotics, and corticosteroids),
ICUAW starts within few hours of ICU admission, affects the limbs, particularly the lower extremities as well as
the respiratory muscles impeding weaning from mechanical ventilation, leading to prolonged hospitalization and
eventual short-term and long-term functional impairment and reduced quality of life. Currently, no effective
treatment exists for ICUAW and the focus is primarily on early mobility preventive measures. Current early
mobility program is executed by physical therapy and requires patient’s cooperation and could not be performed
immediately after ICU admission in critically ill/mechanically ventilated patients. Therefore, there is high
interest in being able to intervene early via non-volitional exercise strategies. One such promising strategy is
“Electrical Muscle Stimulation” (EMS). EMS passively activates muscles using skin-surface electrodes and
electrical pulses. Clinical data from the literature support the use of EMS as a tool for early rehabilitation.
However, technical limitations prevented widespread adoption of EMS in ICUs: (1) no EMS device is developed
for ICU use raising safety questions related to electromagnetic interference (EMI) with cardiac monitoring
systems as well as life sustaining equipment such as cardiac implanted electronic devices and external
defibrillators; (2) the continuous presence of a skilled operator on site to set up the device and continuously
monitor the treatment session (by assessing physiological feedback from the patient and making adjustments)
increase the workload and cost of the intervention. We reasoned that an EMS device with low electric noise could
reduce the risk of EMI. Additionally, we reasoned that using real-time muscle bioelectric feedback in response
to electric stimulation could create the basis for a closed loop system. A low noise EMS system showed promising
results when tested with an ECG system. In addition, we find that the use of real-time bioelectric feedback is
reliable in detecting muscle response to electrical stimulation. Therefore, in this project we will integrate a
bioelectric feedback device with a low noise EMS device to create a CL-EMS system that is safe for use in ICU
setting. In phase 1 of this project, the electrical design integration of the closed loop prototype system was
completed successfully – preliminary safety was validated in a clinical trial in healthy volunteers. In phase 2 a
commercial prototype of the CL-EMS system will be built and tested for safety and feasibility in inducing an
effective muscle contraction in the intended use setting. The validation process will include IEC testing and
...

## Key facts

- **NIH application ID:** 10920531
- **Project number:** 2R44EB033725-02
- **Recipient organization:** HEALTH DISCOVERY LABS LLC
- **Principal Investigator:** Oussama Hassan
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $874,061
- **Award type:** 2
- **Project period:** 2022-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10920531

## Citation

> US National Institutes of Health, RePORTER application 10920531, Closed Loop Electrical Muscle Stimulation System (CL-EMS) with improved safety for ICU environment to mitigate ICU Acquired Weakness (2R44EB033725-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10920531. Licensed CC0.

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