Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome

Post-intensive care syndrome (PICS) encompasses persistent physical, cognitive, and psychiatric symptoms following ICU discharge, commonly triggered by serious conditions such as respiratory failure, sepsis, and mechanical ventilation. PICS prevalence is reported to be as high as 84% up to 12 months in patients with at least 2 days spent in the ICU or with mechanical ventilatory support. As a consequence, many patients do not return to they former level of function for weeks, months and even years.

Muscular affection manifested by muscle weakness is particularly seen and is provoked by a combination of damage to the nerves or directly the muscles fibers. This affection is referred to as CU-Acquired Weakness (ICUAW). One third of the time, lower extremities are affected, often due to prolonged immobilization or sedation. Evidence suggests that early mobilization reduces the incidence of ICUAW at discharge and improves the number of patients able of stand. However achieving this early intervention is not always feasible due to time or personnel constraints.

The purpose of the study is to examine the effectiveness of lower extremity neuromodulation for prevention of muscle deconditioning in patients admitted to the ICU.

Study Overview

• Status: Recruiting
• Conditions: Muscle Weakness; Muscle Atrophy; Blood Flow
• Intervention / Treatment: Device: Intervention Group; Device: Control Group

Detailed Description

The purpose of the study is to examine feasibility and acceptability of lower extremity neuromodulation in patients at risk of ICUAW. This is a proof Randomized controlled trial (RCT) study for prevention. Eligible participants will be recruited from Baylor St Luke's Medical Center (Houston, Texas).

Participants will be randomized to intervention group (IG) or control group (CG). The entire cohort will receive daily neuromodulation in the lower extremity (Gastrocnemius muscle, Achilles tendon) up to 1 hour. The therapy will be provided with a neuromodulation device (Tennant Biomodulator PRO®, AVAZZIA, Inc.) that works on high voltage alternative pulsed current. The device will be functional for the IG and non-functional for the CG.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Maria Noun, BS; Phone Number: 713-798-7538; Email: maria.noun@bcm.edu
• Study Contact Backup: Name: Bijan Najafi, PhD; Phone Number: 713-798-7538; Email: bijan.najafi@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Maria Noun, BS; Phone Number: 713-798-7538; Email: maria.noun@bcm.edu
      • Contact: Bijan Najafi, PhD; Phone Number: 713-798-7536; Email: bijan.najafi@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any patient older than 18 years old admitted to the ICU within 2 days.
• Patient can be intubated with ventilatory assistance or not.

Exclusion Criteria:

• Less than 48 hours of ICU stay.
• Major foot problems such as active lower extremity wounds, major foot deformity (e.g., Charcot Foot), and/or previous major amputations.
• Demand-type cardiac pacemaker, implanted defibrillator, or other implanted electronic devices.
• Any conditions that may interfere with outcomes or increase the risk of the use neuromodulation therapy based on the judgement of clinicians.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.	Device: Intervention Group; Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
Sham Comparator: Control group; Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.	Device: Control Group; Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrocnemius muscle endurance at 4 weeks	Gastrocnemius muscle endurance will be measured in response to 5 minute neuromodulation recorded by surface electromyography (Delsys Trigno).	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrocnemius muscle thickness at 4 weeks	Thickness of medial gastrocnemius muscle will be measured using portable muscle ultrasound (VscanAir).	up to 4 weeks
Plantar Saturation of oxygen at 4 weeks	Plantar saturation of oxygen will be obtained before and after neuromodulation for 1 hour. A non-invasive near-infrared spectroscopy camera (Snapshot, Kent imaging) will be used to obtain Saturation of Oxygen in response to neuromodulation.	up to 4 weeks
Ankle strength at 4 weeks	Maximum Voluntary Contraction will be assed using a dynamometer during isometric plantar flexion for 5 seconds.	up to 4 weeks
Sural nerve conduction at 4 weeks	Sural nerve conduction will be assessed using the DPN check device (Neurometrix Inc).	up to 4 weeks.
Sural nerve amplitude at 4 weeks	Sural nerve amplitude will be assessed using the DPN check device (Neurometrix Inc).	up to 4 weeks.
Deep Vein Thrombosis events at 4 weeks	Deep Vein Thrombosis events will be obtained from the patient electronic medical records' doppler ultrasound technician report.	up to 4 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety level 4 weeks after hospital discharge	Anxiety levels will be measured using the Beck anxiety inventory validated questionnaire. The minimum score is 0, meaning low anxiety, and the maximum score is 63 , meaning potential concerning levels of anxiety.	1 month after study termination (up to 8 weeks).
Independence activities of daily living (IADL) 4 weeks after hospital discharge	Independence activities of daily living will be measured using Katz Index Scale . The minimum score is 0, meaning patient independent, and the maximum score is 6, meaning patient very dependent.	1 month after study termination (up to 8 weeks).
Instrumental Activities of daily living (IADL) 4 weeks after hospital discharge	Independence in Instrumental activities of daily living will be measured Lawton Brody Scale . The minimum score is 0, meaning low function-dependent, and the maximum score is 8, meaning high function independent.	1 month after study termination (up to 8 weeks).
Individuals mobility and participation in various life spaces or environments	Individuals functional mobility and extent of community engagement will be measured with the UAB life space questionnaire. The minimum score is 0, totally bed-bound, and the maximum score is 120, meaning traveling everyday out of town without assistance.	1 month after study termination (up to 8 weeks).

Collaborators and Investigators

• Sponsor: Bijan Najafi, PhD
• Collaborators: Avazzia, Inc

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Estimated): August 28, 2025
• Study Completion (Estimated): August 28, 2025

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: neuromodulation; muscle dysfunction; skin perfussion
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscle Weakness; Muscular Atrophy; Asthenia
• Other Study ID Numbers: H-52968

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No