Electrical Stimulation for Fatigue

Overseen By Hugo Pereira, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Metal implants, Neuromuscular disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

40 Participants Needed

Trial Summary

What is the purpose of this trial?

In this project, we aim to determine any potential effects of a weak electrical current applied to the neck or thoracic area on functional capacity and muscle activation. Healthy individuals will participate in one familiarization followed by three experimental sessions. Fatigability and motor function will be assessed in each test session.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial organizers for more details.

What data supports the effectiveness of this treatment for fatigue?

Research shows that neuromuscular electrical stimulation (NMES) can effectively strengthen weak muscles and improve muscle function in conditions like stroke and knee osteoarthritis. Functional electrical stimulation (FES) has also been shown to help improve walking performance in people with multiple sclerosis, suggesting potential benefits for fatigue management. ^{1 2 3 4 5}

Is electrical stimulation generally safe for humans?

Electrical stimulation methods like NMES and TENS are generally considered safe for humans, but they can cause discomfort, especially when strong muscle contractions are involved. It's important to follow recommended guidelines for safe and effective use. ^{1 2 6 7 8}

How does electrical stimulation for fatigue differ from other treatments?

Electrical stimulation for fatigue is unique because it uses electrical currents to directly stimulate muscles or nerves, which can help reduce muscle fatigue and improve recovery. Unlike other treatments that might involve medication or rest, this method targets the muscles or nerves directly to enhance their function and resistance to fatigue. ^{8 9 10 11 12}

Research Team

Hugo Pereira, PhD

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for healthy individuals aged 18 to 50 who want to help explore how weak electrical stimulation might affect muscle function and energy levels. People with neuromuscular diseases, skin hypersensitivity, or metal implants/joint replacements cannot participate.

Inclusion Criteria

I am between 18 and 50 years old and healthy.

Exclusion Criteria

I have a neuromuscular disease.

You have metal implants or have had joint replacement surgery.

You have a severe allergic reaction to skin contact.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Familiarization

Participants undergo a familiarization session to get accustomed to the procedures

2 hours

1 visit (in-person)

Experimental Sessions

Participants undergo three experimental sessions where fatigability and motor function are assessed

6 hours total (3 sessions, 2 hours each)

3 visits (in-person)

Follow-up

Participants are monitored for any delayed effects of the neuromodulation

2-4 weeks

Treatment Details

Interventions

• Electrical Stimulation

Trial Overview The study tests the impact of applying a weak electrical current to the neck or thoracic area on muscle activation and stamina in healthy adults. Participants will undergo one familiarization session followed by three experimental sessions assessing motor function.

Participant Groups

Group I: Women Experimental Treatment 1 Intervention

Individuals will participate in 1 familiarization and 3 test sessions

Group II: Men Experimental Treatment 1 Intervention

Individuals will participate in 1 familiarization and 3 test sessions

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Findings from Research

A systematic review of literature on neuromuscular electrical stimulation (NMES) identified effective stimulation parameters for treating muscle impairments in conditions like stroke, ACL reconstruction, and knee osteoarthritis, based on a consensus among six Canadian PT experts.

The article serves as a comprehensive resource for physiotherapists, offering evidence-based recommendations and safety tips for the effective application of NMES in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. Nussbaum, EL., Houghton, P., Anthony, J., et al.[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]

In a trial involving 44 participants with secondary progressive multiple sclerosis, those receiving exercise therapy showed significant improvements in walking speed and endurance compared to those using functional electrical stimulation (FES).

While FES did not improve walking performance without stimulation, it provided an orthotic benefit during stimulation, suggesting that combining FES with exercise may enhance overall therapeutic effects for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis. Barrett, CL., Mann, GE., Taylor, PN., et al.[2022]

Recent research highlights that electrical stimulation of motor nerves can enhance muscle strength, reduce muscle spasms, and help manage spasticity, making it a valuable tool in physiotherapy.

Functional electrical stimulation (F.E.S.) is gaining traction as a key component in rehabilitation programs for patients with neurological impairments, suggesting its potential for broader application in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor stimulation with interferential currents. DE Domenico, GG., Strauss, GR.[2014]

The study introduces a real-time functional electrical stimulation (FES) system that uses electromyography (eEMG) signals to predict joint torque, which is crucial for personalized rehabilitation in spinal cord injury (SCI) patients.

Testing on 3 able-bodied subjects and 3 SCI patients showed that both the Kalman filter and recurrent neural network (RNN) methods effectively estimated joint torque, with RNN being more computationally efficient, indicating potential for practical use in personalized neuroprosthetic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time estimation of FES-induced joint torque with evoked EMG : Application to spinal cord injured patients. Li, Z., Guiraud, D., Andreu, D., et al.[2019]

A study involving 713 chronic pain patients showed that fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) significantly reduced pain intensity and interference with daily activities and mood after 60 days of use.

The effectiveness of FS-TENS improved with increased usage, with 57.1% of high-utilization users experiencing clinically meaningful reductions in pain interference, highlighting the importance of consistent application for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. Kong, X., Gozani, SN.[2022]

In a study involving 24 young adults, sensory transcutaneous electrical nerve stimulation (TENS) did not significantly reduce discomfort during neuromuscular electrical stimulation or enhance the strength of muscle contractions.

Participants reported more discomfort from the muscle contractions themselves than from the electrical current, indicating that TENS may not be effective for alleviating discomfort in this context, and further research is needed to explore different stimulation parameters in patients with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory transcutaneous electrical stimulation fails to decrease discomfort associated with neuromuscular electrical stimulation in healthy individuals. Laufer, Y., Tausher, H., Esh, R., et al.[2016]

In a study involving 20 healthy males, neuromuscular electrical stimulation (NMES) led to a significant decrease in maximal voluntary contraction (MVC) torque after just one sequence, indicating early onset of neuromuscular fatigue.

Cortical activity in both the primary motor (M1) and primary somatosensory (S1) areas declined during NMES, suggesting that the motor cortex is involved in the loss of force, but the decrease in motor output is not due to increased inhibition from the sensory cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical motor output decreases after neuromuscular fatigue induced by electrical stimulation of the plantar flexor muscles. Alexandre, F., Derosiere, G., Papaiordanidou, M., et al.[2015]

In a study involving 11 healthy men, both low-frequency pulsed current (PC) and medium-frequency current (MF) neuromuscular electrical stimulation (NMES) sessions resulted in similar levels of neuromuscular fatigue, as indicated by decreases in maximal voluntary contraction (MVC) and electromyographic activity (EMG).

Clinicians can confidently use either PC or MF NMES for muscle strength training, as both methods produced comparable effects on muscle performance and discomfort levels during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular fatigue after low- and medium-frequency electrical stimulation in healthy adults. De Oliveira, PFA., Durigan, JLQ., Modesto, KAG., et al.[2019]

In a study involving 11 trained men cycling for 2 hours, significant central fatigue was observed, as indicated by a 22% decline in maximal voluntary contraction (MVC) and a decrease in central activation ratio from 83% to 71%.

Peripheral magnetic stimulation (PMS) effectively elicited strong quadriceps contractions and may be a superior method for assessing central fatigue compared to traditional techniques, as it caused a 17% decrease in force output after exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central fatigue after cycling evaluated using peripheral magnetic stimulation. Kremenic, IJ., Glace, BW., Ben-Avi, SS., et al.[2009]

The study evaluated the fatigue development of 6 paralyzed quadriceps muscles during 180 dynamic contractions using different electrode configurations, but found no significant difference in fatigue resistance between distributed and conventional stimulation methods.

Maximal torque production occurred at knee-extension angles of 130°-140°, which is relevant for dynamic movements like running, suggesting that fatigue testing should focus on higher forces to better simulate practical applications of functional electrical stimulation (FES).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardizing fatigue-resistance testing during electrical stimulation of paralysed human quadriceps muscles, a practical approach. Schmoll, M., Le Guillou, R., Lobato Borges, D., et al.[2021]

In a study involving 32 healthy men, microcurrent stimulation significantly reduced muscle fatigue and muscle tone in the erector spinae after repeated lifting tasks, compared to a control group that only rested.

Transcutaneous electrical nerve stimulation (TENS) did not show any significant effects on muscle recovery when compared to the control group, indicating that microcurrent may be a more effective intervention for fatigue recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of low-frequency electrical stimulation on cumulative fatigue and muscle tone of the erector spinae. Kang, DH., Jeon, JK., Lee, JH.[2020]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]

3. England pubmed.ncbi.nlm.nih.gov

A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Motor stimulation with interferential currents. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Real-time estimation of FES-induced joint torque with evoked EMG : Application to spinal cord injured patients. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Sensory transcutaneous electrical stimulation fails to decrease discomfort associated with neuromuscular electrical stimulation in healthy individuals. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Cortical motor output decreases after neuromuscular fatigue induced by electrical stimulation of the plantar flexor muscles. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Neuromuscular fatigue after low- and medium-frequency electrical stimulation in healthy adults. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Central fatigue after cycling evaluated using peripheral magnetic stimulation. [2009]

11. England pubmed.ncbi.nlm.nih.gov

Standardizing fatigue-resistance testing during electrical stimulation of paralysed human quadriceps muscles, a practical approach. [2021]

12. Japan pubmed.ncbi.nlm.nih.gov

Effects of low-frequency electrical stimulation on cumulative fatigue and muscle tone of the erector spinae. [2020]