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

Not Applicable

Active, not recruiting

Conditions: Muscle Atrophy
Muscle Weakness
Blood Flow

Interventions: Device: Intervention Group
Device: Control Group

Registration Number: NCT06238609

Lead Sponsor: Bijan Najafi, PhD

Brief 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.

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 25

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	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	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.

Primary Outcome Measures

Name	Time	Method
Gastrocnemius Muscle Endurance at Endpoint	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 Outcome Measures

Name	Time	Method
Ankle Strength at 4 Weeks	up to 4 weeks	Maximum Voluntary Contraction will be assed using a dynamometer during isometric plantar flexion for 5 seconds.
Change in Gastrocnemius Muscle Thickness at 4 Weeks Compared to Baseline	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
Percentage of Tissue Oxygen Saturation at Endpoint	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.
Sural Nerve Conduction at 4 Weeks	up to 4 weeks.	Sural nerve conduction will be assessed using the DPN check device (Neurometrix Inc).
Sural Nerve Amplitude at 4 Weeks	up to 4 weeks.	Sural nerve amplitude will be assessed using the DPN check device (Neurometrix Inc).