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NCT06238609 · ClinicalTrials.gov registry record · NA

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

A NA study of Muscle Weakness and Muscle Atrophy, sponsored by Bijan Najafi, PhD.

Active
Registry status
NA
Development phase
25
Enrollment target
1
Study location

NCT06238609: Active NA study of Muscle Weakness and Muscle Atrophy, sponsored by Bijan Najafi, PhD.

NCT06238609 is a NA study of Muscle Weakness and Muscle Atrophy that is active but no longer recruiting, run by Bijan Najafi, PhD. The registered enrollment target is 25 participants, below the 74-participant average among 25 other Muscle Weakness trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06238609, a NA study of Muscle Weakness and Muscle Atrophy, is active but no longer recruiting, sponsored by Bijan Najafi, PhD.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
25 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Interventions

  • DEVICE Intervention Group
  • DEVICE Control Group

Study Locations (1)

Texas

  • Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2023-08-28
Est. Completion 2025-08-28
Phase NA
Bijan Najafi, PhD

5 total trials

What the registry record for NCT06238609 still lists

NCT06238609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 74-participant average among 25 other Muscle Weakness trials with a reported enrollment target (66% lower).

The record links to 3 conditions, with Muscle Weakness appearing as the primary indexed condition, and to 2 interventions - of which Intervention Group is the first listed.

NCT06238609 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06238609 about?

NCT06238609 is a clinical study titled "Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome". 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...

What is the current status of trial NCT06238609?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2023-08-28. Estimated completion is 2025-08-28.

What conditions does trial NCT06238609 study?

This clinical trial studies the following conditions: Muscle Weakness, Muscle Atrophy, Blood Flow.

What interventions are being tested in trial NCT06238609?

The interventions under investigation include: Intervention Group (DEVICE), Control Group (DEVICE).

Who is sponsoring clinical trial NCT06238609?

This trial is sponsored by Bijan Najafi, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06238609 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Muscle Weakness

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06238609's enrollment target sits among peer trials

25 20th of 25 higher than 6 of 25 other Muscle Weakness trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Muscle Weakness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06238609, the US trial registry maintained by the National Library of Medicine. NCT06238609 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.