Neuromodulation for Muscle Weakness
Trial Summary
What is the purpose of this trial?
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.
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 data supports the idea that Neuromodulation for Muscle Weakness is an effective treatment?
The available research shows that Neuromodulation for Muscle Weakness, also known as Neuromuscular Electrical Stimulation (NMES), is effective in strengthening weak muscles. One study highlights that NMES can improve muscle strength, as there is a positive relationship between the muscle forces generated during training and the gains in strength. However, patient discomfort can limit the effectiveness of NMES. Another study suggests that NMES can aid in recovery after lower extremity injuries or surgeries, especially when used at home with proper monitoring and communication with healthcare providers. This indicates that NMES can be a beneficial treatment for muscle weakness, particularly when adherence to the treatment is maintained.12345
What data supports the effectiveness of the treatment Neuromodulation for Muscle Weakness?
Research shows that neuromuscular electrical stimulation (NMES), a part of this treatment, is effective in strengthening weak muscles by improving their force-generating capacity. However, patient discomfort can limit its effectiveness, and adherence to at-home use is crucial for better outcomes.12345
What safety data is available for neuromodulation treatments for muscle weakness?
The safety data for neuromodulation treatments, such as Neuromuscular Electrical Stimulation (NMES), indicates that it is a widely-used and generally safe technique for muscle strengthening and rehabilitation. NMES is effective in enhancing muscle function and has been shown to be feasible even for ill or bedridden patients. However, there are specific contraindications, such as peripheral venous disorders or malignancy, where NMES should be avoided. Patient discomfort and non-response due to peripheral nerve damage are potential issues, but these can be managed with proper electrode placement and consideration of underlying conditions.23467
Is neuromuscular electrical stimulation (NMES) safe for humans?
Neuromuscular electrical stimulation (NMES) is generally considered safe for humans, even for those who are ill or bedridden, although it may cause discomfort and has specific contraindications (reasons not to use it) such as peripheral venous disorders or cancer. It is important to ensure proper electrode placement to minimize discomfort and maximize effectiveness.23467
Is Lower Extremity Neuromodulation a promising treatment for muscle weakness?
How is the Lower Extremity Neuromodulation treatment different from other treatments for muscle weakness?
Lower Extremity Neuromodulation, also known as Neuromuscular Electrical Stimulation (NMES), is unique because it uses electrical currents to directly stimulate muscles, helping to strengthen them even when voluntary movement is limited. This approach can be particularly beneficial for patients with muscle weakness due to nerve damage, as it bypasses the need for voluntary muscle activation.23468
Eligibility Criteria
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
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
Treatment Details
Interventions
- Lower Extremity Neuromodulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bijan Najafi, PhD
Lead Sponsor
Avazzia, Inc
Industry Sponsor