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Behavioural Intervention

Intervention Group for Blood Circulation

Phase 1

Recruiting

Research Sponsored by Bijan Najafi, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month after study termination (up to 8 weeks).

Awards & highlights

Study Summary

This trial aims to study the effectiveness of a treatment called lower extremity neuromodulation in preventing muscle weakness in patients who have been in the intensive care unit. Many patients who have serious conditions and

Who is the study for?

This trial is for patients who have been in the ICU, especially those on ventilators or with serious conditions like respiratory failure or sepsis. It aims to help those at risk of developing muscle weakness and wasting after their ICU stay.Check my eligibility

What is being tested?

The study tests if neuromodulation (stimulating nerves/muscles) can prevent muscle weakening in ICU patients. Participants are divided into two groups: one receives standard care while the other gets additional lower extremity neuromodulation.See study design

What are the potential side effects?

While specific side effects aren't listed, interventions like neuromodulation may cause discomfort, skin irritation at the stimulation site, or unintended muscle responses during treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after study termination (up to 8 weeks).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month after study termination (up to 8 weeks).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after study termination (up to 8 weeks). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gastrocnemius muscle endurance at 4 weeks

Secondary outcome measures

Ankle strength at 4 weeks

Deep Vein Thrombosis events at 4 weeks

Gastrocnemius muscle thickness at 4 weeks

+3 more

Other outcome measures

Anxiety level 4 weeks after hospital discharge

Independence activities of daily living (IADL) 4 weeks after hospital discharge

Individuals mobility and participation in various life spaces or environments

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intervention GroupActive Control1 Intervention

Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.

Group II: Control groupPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Bijan Najafi, PhDLead Sponsor

4 Previous Clinical Trials

294 Total Patients Enrolled

Avazzia, IncIndustry Sponsor

6 Previous Clinical Trials

262 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still eligible to enroll in this ongoing clinical trial?

"As stated on clinicaltrials.gov, this current trial is in the recruitment phase. The study was first listed on 8/28/2023 and most recently revised on 1/25/2024."

Answered by AI

How large is the patient cohort enrolled in this medical study?

"Indeed, the details displayed on clinicaltrials.gov indicate that this investigation is actively seeking candidates. It was originally posted on August 28th, 2023 and last modified on January 25th, 2024. The trial aims to enroll a total of 40 participants at one designated site."

Answered by AI

What risks does the Intervention Group pose to participants?

"The safety rating given by our team at Power for the Intervention Group is 1. This score reflects that as a Phase 1 trial, there exists only minimal evidence supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Bijan Najafi, PhD 2023. "Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06238609.

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