CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 25 enrolled
Drug / intervention
Intervention Group +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06238609
NCT06238609N/AActive

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

Bijan Najafi, PhD·interventional·Posted Feb 2, 2024·Updated Dec 30, 2024

In Brief

A clinical study evaluating Intervention Group and Control Group for Muscle Atrophy and 2 related conditions. Active but no longer recruiting, targeting 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAvazzia, Inc

Timeline

N/AActiveOverdue
202420252026
First PostedFeb 2, 2024
Enrollment StartAug 28, 2023
Primary CompletionJun 26, 2024
Study CompletionAug 28, 2025
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 2.4 years ago

Interventions

Intervention Groupdevice

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 Groupdevice

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.