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

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238609
• Other study ID #: H-52968
• Status: Recruiting
• Phase: Phase 1
• Start date: August 28, 2023
• Est. completion date: August 28, 2025

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: Bijan Najafi, PhD
• Phone: 713-798-7538
• Email: bijan.najafi[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 28, 2025
• Est. primary completion date: August 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthenia
• Blood Flow
• Muscle Atrophy
• Muscle Weakness
• Muscular Atrophy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Bijan Najafi, PhD	Avazzia, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Other	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).
Other	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).
Other	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).
Primary	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	Gastrocnemius muscle thickness at 4 weeks	Thickness of medial gastrocnemius muscle will be measured using portable muscle ultrasound (VscanAir).	up to 4 weeks
Secondary	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
Secondary	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
Secondary	Sural nerve conduction at 4 weeks	Sural nerve conduction will be assessed using the DPN check device (Neurometrix Inc).	up to 4 weeks.
Secondary	Sural nerve amplitude at 4 weeks	Sural nerve amplitude will be assessed using the DPN check device (Neurometrix Inc).	up to 4 weeks.
Secondary	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.