Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06238609

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Muscle Atrophy Atrophy Blood Flow Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Group

Device

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

Device

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.

Primary outcomes

  1. Gastrocnemius Muscle Endurance at Endpoint

    Time frame: Up to 4 weeks

    Gastrocnemius muscle endurance was assessed by measuring sustained involuntary muscle contractions using surface electromyography (sEMG; Delsys Trigno). During a 60-minute electrical stimulation therapy session, sEMG signals were recorded from the last two minutes of the therapy to evaluate muscle activity in response to electrical stimulation. The recorded sEMG data were normalized to the average sEMG signals captured during the same interval, yielding values in normalized units (n.u.), higher values indicate higher muscle endurance.

    The endpoint was defined as either the last day in the hospital or the completion of week 4 of the intervention, whichever occurred first.

Secondary outcomes

  1. Change in Gastrocnemius Muscle Thickness at 4 Weeks Compared to Baseline

    Time frame: Up to 4 weeks

    The thickness of the medial gastrocnemius muscle was measured using a portable muscle ultrasound device (Vscan Air). Changes in gastrocnemius thickness (measured in cm) from baseline to the endpoint were calculated, and the average change was reported.

    The endpoint was defined as either the last day in the hospital or the completion of week 4 of the intervention, whichever occurred first

  2. Percentage of Tissue Oxygen Saturation at Endpoint

    Time frame: up to 4 weeks

    Percentage of tissue oxygen saturation was measured at endpoint (study conclusion) at three time points: before neuromodulation (minute 0), immediately after 1 hour of neuromodulation (minute 60), and 10 minutes post-neuromodulation (minute 70) at the plantar region, following the protocol described by Zurbaran-Rojas et al. (Physiological Reports, 2023, DOI: 10.14814/phy2.15636). A non-invasive near-infrared spectroscopy camera (Snapshot, Kent Imaging) will be used to obtain oxygen saturation in response to neuromodulation.

    The endpoint was defined as either the last day in the hospital or up to week 4 of the intervention, whichever came first.

  3. Ankle Strength at 4 Weeks

    Time frame: up to 4 weeks

    Maximum Voluntary Contraction will be assed using a dynamometer during isometric plantar flexion for 5 seconds.

  4. Sural Nerve Conduction at 4 Weeks

    Time frame: up to 4 weeks.

    Sural nerve conduction will be assessed using the DPN check device (Neurometrix Inc).

  5. Sural Nerve Amplitude at 4 Weeks

    Time frame: up to 4 weeks.

    Sural nerve amplitude will be assessed using the DPN check device (Neurometrix Inc).

Other outcomes

  1. Anxiety Level 4 Weeks After Hospital Discharge

    Time frame: 1 month after study termination (up to 8 weeks).

    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.

  2. Independence Activities of Daily Living (ADL) 4 Weeks After Hospital Discharge

    Time frame: 1 month after study termination (up to 8 weeks).

    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.

  3. Instrumental Activities of Daily Living (IADL) 4 Weeks After Hospital Discharge

    Time frame: 1 month after study termination (up to 8 weeks).

    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.

  4. Individuals Mobility and Participation in Various Life Spaces or Environments

    Time frame: 1 month after study termination (up to 8 weeks).

    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.

  5. Deep Vein Thrombosis Events at 4 Weeks

    Time frame: 4 weeks

    The incidence of deep vein thrombosis was documented from electronic health records at week 4 following the initiation of the intervention.

Sponsors and collaborators

Lead sponsor

Bijan Najafi, PhD

Other

Collaborators

  • Avazzia, Inc

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 2, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.