Clinical trial NCT06238609: Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome
Official title: Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Muscle Atrophy
Muscle Weakness
Blood Flow
Keywords: neuromodulation
skin perfussion
muscle dysfunction
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Avazzia, Inc
First posted: 2024-02-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will receive daily neuromodulation in lower extremity (e.g. Gastronemius muscle) for up to 1 hour. The neuromodulation device will be functional for IG and non-functional for CG.

Phase I will include patients admitted to the Intensive care Unit. The study duration will be 4 weeks or until hospital discharge, whichever comes first.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastrocnemius Muscle Endurance at Endpoint
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Change in Gastrocnemius Muscle Thickness at 4 Weeks Compared to Baseline
timeFrame: Up to 4 weeks
measure: Percentage of Tissue Oxygen Saturation at Endpoint
timeFrame: up to 4 weeks
measure: Ankle Strength at 4 Weeks
timeFrame: up to 4 weeks
measure: Sural Nerve Conduction at 4 Weeks
timeFrame: up to 4 weeks.
measure: Sural Nerve Amplitude at 4 Weeks
timeFrame: up to 4 weeks.
Other outcomes:
measure: Anxiety Level 4 Weeks After Hospital Discharge
timeFrame: 1 month after study termination (up to 8 weeks).
measure: Independence Activities of Daily Living (ADL) 4 Weeks After Hospital Discharge
timeFrame: 1 month after study termination (up to 8 weeks).
measure: Instrumental Activities of Daily Living (IADL) 4 Weeks After Hospital Discharge
timeFrame: 1 month after study termination (up to 8 weeks).
measure: Individuals Mobility and Participation in Various Life Spaces or Environments
timeFrame: 1 month after study termination (up to 8 weeks).
measure: Deep Vein Thrombosis Events at 4 Weeks
timeFrame: 4 weeks
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: Zulbaran-Rojas A, Lee M, Bara RO, Flores-Camargo A, Spitz G, Finco MG, Bagheri AB, Modi D, Shaib F, Najafi B. Electrical stimulation to regain lower extremity muscle perfusion and endurance in patients with post-acute sequelae of SARS CoV-2: A randomized controlled trial. Physiol Rep. 2023 Mar;11(5):e15636. doi: 10.14814/phy2.15636.