R44EB033725

Closed loop electrical muscle stimulation system (CL-EMS) with improved safety for ICU environment to mitigate ICU acquired weakness - 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) increases 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 testing in critically ill patients.

Health Discovery Labs

TO SUPPORT HYPOTHESIS-, DESIGN-, TECHNOLOGY-, OR DEVICE-DRIVEN RESEARCH RELATED TO THE DISCOVERY, DESIGN, DEVELOPMENT, VALIDATION, AND APPLICATION OF TECHNOLOGIES FOR BIOMEDICAL IMAGING AND BIOENGINEERING. THE PROGRAM INCLUDES BIOMATERIALS (BIOMIMETICS, BIOPROCESSING, ORGANOGENESIS, REHABILITATION, TISSUE ENGINEERING, IMPLANT SCIENCE, MATERIAL SCIENCE, INTERFACE SCIENCE, PHYSICS AND STRESS ENGINEERING, TECHNOLOGY ASSESSMENT OF MATERIALS/DEVICES), BIOSENSORS/BIOTRANSDUCERS (TECHNOLOGY DEVELOPMENT, TECHNOLOGY ASSESSMENT, DEVELOPMENT OF ALGORITHMS, TELEMETRY), NANOTECHNOLOGY (NANOSCIENCE, BIOMIMETICS, DRUG DELIVERY SYSTEMS, DRUG BIOAVAILABILITY, MICROARRAY/COMBINATORIAL TECHNOLOGY, GENETIC ENGINEERING, COMPUTER SCIENCE, TECHNOLOGY ASSESSMENT), BIOINFORMATICS (COMPUTER SCIENCE, INFORMATION SCIENCE, MATHEMATICS, BIOMECHANICS, COMPUTATIONAL MODELING AND SIMULATION, REMOTE DIAGNOSIS AND THERAPY), IMAGING DEVICE DEVELOPMENT, BIOMEDICAL IMAGING TECHNOLOGY DEVELOPMENT, IMAGE EXPLOITATION, CONTRAST AGENTS, INFORMATICS AND COMPUTER SCIENCES RELATED TO IMAGING, MOLECULAR AND CELLULAR IMAGING, BIOELECTRICS/BIOMAGNETICS, ORGAN AND WHOLE BODY IMAGING, SCREENING FOR DISEASES AND DISORDERS, AND IMAGING TECHNOLOGY ASSESSMENT AND SURGERY (TECHNIQUE DEVELOPMENT AND TECHNOLOGY DEVELOPMENT).

93.286 - Discovery and Applied Research for Technological Innovations to Improve Human Health

National Institute of Biomedical Imaging and Bioengineering (NIBIB) [HHS - NIH]

Austin, Texas 787492245 United States

Single Zip Code

PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) (PA-23-231)

Amendment Since initial award the total obligations have increased 132% from $847,839 to $1,969,073.