NCT06238609

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Bijan Najafi, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Muscle Atrophy
• Muscle Weakness
• Blood Flow

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-08-28
• Primary completion: 2024-06-26
• Completion: 2025-08-28
• First posted: 2024-02-02
• Last updated: 2024-12-30
• Results posted: 2024-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study