Neuromodulation for Muscle Weakness

Overseen By Maria Noun, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bijan Najafi, PhD

Disqualifiers: Foot problems, Cardiac devices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

I have spent less than 48 hours in the ICU.

I have major foot problems like wounds, deformities, or past amputations.

Demand-type cardiac pacemaker, implanted defibrillator, or other implanted electronic devices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

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

Up to 4 weeks

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of muscle endurance, thickness, and other health metrics

4 weeks

Post-study Follow-up

Anxiety levels, independence in daily living activities, and mobility are assessed 4 weeks after hospital discharge

1 month after study termination

What Are the Treatments Tested in This Trial?

Interventions

• Lower Extremity Neuromodulation

Trial Overview

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.

How Is the Trial Designed?

Group I: Intervention Group Active Control 1 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 group Placebo Group 1 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.

Who Is Running the Clinical Trial?

Bijan Najafi, PhD

Lead Sponsor

Trials

5

Recruited

280+

Avazzia, Inc

Industry Sponsor

Trials

7

Recruited

290+

Published Research Related to This Trial

Neuromuscular electrical stimulation (NMES) is a safe and effective method for enhancing muscle function, capable of inducing physiological adaptations like muscle hypertrophy and angiogenesis, even in populations unable to perform rigorous exercise.

The study outlines a protocol for using NMES in a murine model, which allows for precise control and feedback in muscle stimulation, demonstrating its applicability in both clinical and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A murine model of muscle training by neuromuscular electrical stimulation. Ambrosio, F., Fitzgerald, GK., Ferrari, R., et al.[2021]

The newly developed NMES-dynamometer system demonstrated high reliability for assessing knee extensor muscle function, with intra-rater correlation coefficients of 0.91 for maximal voluntary force and 0.94 for supramaximal twitch force, indicating consistent results across different testing sessions.

Inter-rater reliability was also strong, with coefficients of 0.89 and 0.86 for the same measures, suggesting that different raters can use this system effectively to evaluate muscle function with minimal variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and reliability of a new system for bedside evaluation of non-volitional knee extension force. Vaz, MA., Fröhlich, M., Júnior, DPDS., et al.[2022]

Neuromuscular electrical stimulation (NMES) can effectively retrain muscles and improve strength, particularly in the quadriceps, by adjusting parameters like pulse duration (400 to 600 μs) and pulse frequency (30 to 50 Hz) to optimize torque production while minimizing discomfort and fatigue.

Clinicians should consider optimal electrode placement and conditioning programs to further enhance the effectiveness of NMES, ensuring better patient outcomes during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the Use of Neuromuscular Electrical Stimulation Be Improved to Optimize Quadriceps Strengthening? Glaviano, NR., Saliba, S.[2019]

In a study involving 10 adults, neuromuscular electrical stimulation (NMES) with a 200-microsecond pulse duration allowed participants to tolerate significantly greater muscle torques compared to a 50-microsecond pulse duration, indicating enhanced efficacy for muscle strengthening.

The findings suggest that medium pulse durations may be more effective for maximizing muscle torque responses, despite the common belief that shorter pulses are preferable due to lower pain thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. Scott, WB., Causey, JB., Marshall, TL.[2014]

The RehabTracker system, designed to monitor adherence to at-home neuromuscular electrical stimulation (NMES) therapy, successfully recorded 83% of rehabilitation sessions in a small cohort of 7 patients recovering from anterior cruciate ligament injuries, indicating its potential effectiveness in improving adherence.

The system's mobile health app facilitated real-time communication between patients and providers, with 100% of push notifications received by patients, suggesting that enhanced monitoring and communication could lead to better rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cyber-Physical System for Near Real-Time Monitoring of At-Home Orthopedic Rehabilitation and Mobile-Based Provider-Patient Communications to Improve Adherence: Development and Formative Evaluation. Stevens, T., McGinnis, RS., Hewgill, B., et al.[2020]

Neuromuscular electrical stimulation (NMES) may fail to elicit muscle responses due to underlying peripheral nerve damage, as demonstrated in two case studies involving patients with unexpected neuropathies.

Simple reaction of degeneration (R/D) tests can effectively identify nerve lesions, guiding further diagnostic evaluations for patients experiencing significant muscle weakness or paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing the reaction of degeneration test for individuals with focal paralysis. Holland, TJ.[2021]

A systematic review of 35 studies involving 353 pediatric participants found that neuromuscular electrical stimulation (NMES) is well-tolerated in children with various neurological conditions, including stroke and spinal cord injury, beyond just cerebral palsy.

Most studies indicated that NMES could enhance traditional therapy methods to improve muscle strength, suggesting its potential as a valuable rehabilitation tool for pediatric patients with neuromuscular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation for motor recovery in pediatric neurological conditions: a scoping review. Yan, D., Vassar, R.[2021]

A study involving 30 healthy participants mapped the locations of muscle motor points (MPs) in the calf, revealing that the highest probability of finding these points is centrally and medially located, particularly in areas 4 and 29, each with a 50% probability.

The findings suggest that using this MP heatmap can improve the comfort and effectiveness of neuromuscular electrical stimulation (NMES) treatments by optimizing electrode placement, potentially enhancing compliance and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor point heatmap of the calf. Schriwer, E., Juthberg, R., Flodin, J., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6464134/

Neuromuscular electrical stimulation for muscle weakness in ...

This review suggests that NMES is a potentially effective treatment for muscle weakness in people with progressive diseases such as cancer, advanced chronic ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0964339722001367

Effectiveness of physical exercise and neuromuscular ...

In patients discharged from the intensive care unit with acquired weakness, both neuromuscular electrical stimulation and physical exercise interventions ...

3.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.1017371/full

Safety and efficacy of electrical stimulation for lower- ...

Physical therapy (PT) greatly benefits neuromuscular outcomes in patients with muscle deconditioning and weakness (17). However, reduced ...

4.

bmcmusculoskeletdisord.biomedcentral.com

bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-09029-5

The effectiveness of neuromuscular electrical stimulation on ...

Effect of early implementation of electrical muscle stimulation to prevent muscle atrophy and weakness in patients after anterior cruciate ...

5.

nature.com

nature.com/articles/s41598-019-43696-4

Chronic neuromuscular electrical stimulation improves ...

Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev 10, CD009419 (2016) ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0883944116304002

Effect of neuromuscular stimulation and individualized ...

MRC improved significantly in patients with ICU-acquired weakness after 2 weeks of NMES. •. Intervention may be beneficial in ICU survivors with ICU-acquired ...

7.

mdpi.com

mdpi.com/2077-0383/13/13/3723

Safety and Feasibility of Neuromuscular Electrical ...

There is also growing evidence that NMES may prevent intensive care acquired weakness (ICUAW), promoting early mobilization in critically ill patients with ...

8.

bmcpulmmed.biomedcentral.com

bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-024-02854-9

Effect of neuromuscular electrical stimulation in critically ill ...

Muscle weakness in septic patients requiring mechanical ventilation: protective effect of transcutaneous neuromuscular electrical stimulation.