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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a weak electrical current applied to the neck or chest might affect fatigue and muscle function. Researchers aim to determine if this type of electrical stimulation can improve muscle performance during fatigue. Healthy men and women will participate in four sessions to test these effects. Healthy adults without metal implants or neuromuscular diseases might be suitable candidates for this trial.

As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance muscle function and reduce fatigue.

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 prior data suggests that this electrical stimulation is safe for humans?

Research shows that using a mild electric current to activate muscles is generally safe, and most people tolerate it well. Neuromuscular electrical stimulation (NMES), for example, is commonly used in physical therapy and has a good safety record.

Some individuals might experience slight discomfort or muscle tiredness, but these effects usually don't last long. One study found that a new method of electrical stimulation helped reduce these sensations.

No serious side effects have been commonly reported. For those considering joining the trial, this evidence suggests that the treatment is likely safe for most healthy individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using electrical stimulation for fatigue because it's a non-invasive way to potentially boost energy levels quickly. Unlike medications that might need weeks to take effect, electrical stimulation can offer immediate results by directly targeting the nervous system. This approach bypasses the need for drugs and their possible side effects, providing an innovative alternative for managing fatigue.

What evidence suggests that electrical stimulation is effective for reducing fatigue?

Research has shown that electrical stimulation can influence muscle function and fatigue rates. Some studies have found that functional electrical stimulation (FES) can strengthen muscles and reduce fatigue in certain situations. For instance, one study discovered that electrical stimulation reduced muscle fatigue and pain during use. While results vary, this treatment has also been noted for increasing muscle size and improving overall quality of life in various cases. Although the evidence is mixed, these findings suggest that electrical stimulation might help manage tiredness and improve movement. Participants in this trial will be divided into two groups, one for men and one for women, to evaluate the effects of electrical stimulation on fatigue. ^{1 5 6 7 8}

Who Is on the Research Team?

Hugo Pereira, PhD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

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 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]

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]

Citations

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Neuromuscular Electrical Stimulation for Treatment of Muscle ... Effectiveness of functional electrical stimulation in improving clinical outcomes in the upper arm following stroke: a systematic review and meta-analysis ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161475423000520

Effect of Functional Electrical Stimulation on Muscle Mass ... This study aimed to evaluate the effects of functional electrical stimulation (FES) on muscle strength, fatigue, muscle mass, and quality of life (QoL) in ...

3. journals.lww.com journals.lww.com/c-orthopaedicpractice/fulltext/2020/07000/the_effect_of_neuromuscular_electrical_stimulation.13.aspx?generateEpub=Article%7Cc-orthopaedicpractice:2020:07000:00013%7C10.1097/bco.0000000000000889%7C

The effect of neuromuscular electrical stimulation on ... 5 Overall, the results revealed inconsistent evidence for the effectiveness of neuromuscular electrical stimulation as a recovery modality following muscle ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01658-0

Delayed muscle fatigue during electrical stimulation of the ... Overall, the results demonstrate that the aSymR stimulation effectively relieves muscle fatigue and alleviates pain and discomfort during ...

5. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2024.1507402/full

achieving physical activity benefits for all abilities Neuromuscular electrical stimulation is effective in strengthening the quadriceps muscle after anterior cruciate ligament surgery. Knee Surg ...

6. aetna.com aetna.com/cpb/medical/data/600_699/0677.html

Functional Electrical Stimulation and Neuromuscular ... This Clinical Policy Bulletin addresses functional electrical stimulation and neuromuscular electrical stimulation.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306452220305637

Fatiguing Neuromuscular Electrical Stimulation Decreases ... Contrary to voluntary muscle fatigue, the sense of effort decreased post-NMES in both tasks despite increased neural outputs to the elbow flexors.

8. physio-pedia.com physio-pedia.com/Neuromuscular_and_Muscular_Electrical_Stimulation_(NMES)

Neuromuscular and Muscular Electrical Stimulation (NMES) NMES is a modality that sends electrical impulses to nerves which causes the muscles to contract mimicking the action potential coming from the central nervous ...