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ACTIVE NOT RECRUITING
NCT06238609
NA

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

Sponsor: Bijan Najafi, PhD

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2023-08-28

Completion Date

2025-08-28

Last Updated

2024-12-30

Healthy Volunteers

No

Interventions

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.

Locations (1)

Baylor College of Medicine

Houston, Texas, United States