Neuromodulation for Muscle Weakness
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a device that stimulates leg muscles can prevent muscle weakness in individuals who have stayed in the Intensive Care Unit (ICU). Muscle weakness commonly affects those who have been in the ICU for two days or more, often due to immobility or sedation. Participants will use either an active or non-active device for about an hour each day to determine its effectiveness in maintaining muscle strength. Candidates for this trial include those admitted to the ICU within the last two days, whether on or off a ventilator. As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery for future ICU patients.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this neuromodulation device is safe for preventing muscle deconditioning?
Research shows that neuromuscular electrical stimulation (NMES) is generally safe for treating muscle weakness. Studies have found it helpful for individuals with conditions like cancer and long-term illnesses. Researchers are also exploring NMES for assisting those with muscle weakness after ICU stays.
One study found that NMES improved muscle strength in patients with ICU-acquired weakness in just two weeks. Another study suggests that NMES may help prevent weakness and support early movement in critically ill patients.
Regarding safety, research indicates that NMES is well-tolerated, with no major adverse events reported. Most people using NMES don't experience serious side effects. Overall, evidence supports NMES as a promising and safe option for improving muscle strength in various conditions.12345Why are researchers excited about this trial?
Most treatments for muscle weakness focus on physical therapy and medications aimed at improving muscle strength and function. However, lower extremity neuromodulation is different because it uses a functional neuromodulation device to stimulate the nerves, potentially enhancing muscle activation and recovery. This approach offers a non-invasive way to target the nervous system directly, which might lead to faster and more efficient muscle strength improvement compared to traditional methods. Researchers are excited about this treatment because it could provide quicker results, helping patients regain mobility sooner.
What evidence suggests that lower extremity neuromodulation is effective for preventing muscle deconditioning in ICU patients?
This trial will compare the effects of a functional neuromodulation device with a non-functional device on muscle weakness. Research has shown that using electrical impulses to stimulate muscles in the lower body, known as neuromuscular electrical stimulation, can help with muscle weakness. Studies have found that this technique benefits patients with weak muscles, especially those recovering from intensive care. This therapy prevents muscle wasting and strengthens weak muscles. Evidence suggests it can effectively supplement or replace physical exercise for patients who find regular activity challenging. Overall, this method has shown promise in helping patients regain muscle function and reduce weakness after ICU stays.12678
Are You a Good Fit for This Trial?
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.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily neuromodulation in the lower extremity for up to 1 hour, using a functional or non-functional device, for up to four weeks or until hospital discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of muscle endurance, thickness, and other health metrics
Post-study Follow-up
Anxiety levels, independence in daily living activities, and mobility are assessed 4 weeks after hospital discharge
What Are the Treatments Tested in This Trial?
Interventions
- Lower Extremity Neuromodulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bijan Najafi, PhD
Lead Sponsor
Avazzia, Inc
Industry Sponsor