40 Participants NeededMy employer runs this trial

Noninvasive Stimulation for Healthy Adults

Recruiting at 2 trial locations
RE
SB
Overseen BySanjay Balaji, Study Coordinator, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how noninvasive techniques, such as external electrical stimulation and ultrasound stimulation, affect the body's functions. Researchers aim to identify measurable changes to determine the potential usefulness of these methods in medical treatments. Participants will receive either actual stimulation or a sham (fake) treatment for comparison. This trial may suit healthy adults without neurological or psychiatric conditions and who do not use certain medications, such as beta-blockers. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to innovative medical treatments.

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

Yes, if you are currently using medications that affect autonomic or cortical function, such as beta-blockers or sedatives, you will need to stop taking them to participate in the trial.

What prior data suggests that these noninvasive stimulation techniques are safe for healthy adults?

Past studies have shown that external electrical stimulation is generally safe for healthy individuals. It can enhance fitness and manage pain without causing serious side effects. However, improper use may lead to risks such as shocks, burns, or skin irritation. Following guidelines is crucial to avoid these issues.

Research has shown that ultrasound stimulation is also mostly safe, particularly at low levels. Some participants have experienced minor side effects like headaches or a feeling of pressure, but studies involving many people have reported no serious problems.

Both treatments are usually well-tolerated when used correctly. Always adhere to instructions and guidelines to minimize risks.12345

Why are researchers excited about this trial?

Researchers are excited about the noninvasive stimulation techniques being tested because they offer a fresh approach to enhancing brain and nervous system function without the need for medication or surgery. External electrical stimulation and ultrasound stimulation are unique because they use targeted energy waves to potentially improve cognitive and neurological performance. Unlike traditional treatments that often rely on drugs, these methods provide a noninvasive alternative that could minimize side effects and make treatments more accessible. Scientists hope these techniques can swiftly activate specific brain areas, providing quicker benefits compared to typical therapies that might take weeks to show results.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the effects of external electrical stimulation and ultrasound stimulation in healthy adults. Research has shown that electrical stimulation applied externally can build muscle strength and improve body shape. Studies have found it can be more effective than aerobic exercise for gaining strength. It has also reduced pain and improved movement in various conditions, such as arm pain in older adults.

Ultrasound stimulation also shows promise. It can alter brain activity without causing harm, indicating safety. This method has been used successfully to assist with certain brain conditions, like essential tremor. Overall, early research suggests it can be a safe and effective way to modify brain function.16789

Are You a Good Fit for This Trial?

This trial is for healthy adults. People with certain medical conditions or other factors that could interfere with the study may not be able to participate.

Inclusion Criteria

Able to provide written informed consent in English
Willing and able to complete study procedures including approximately 1-hour sessions with non-invasive recordings and a 3-hour visit

Exclusion Criteria

I am currently pregnant or breastfeeding.
History of neurological disorders such as epilepsy or migraines or psychiatric conditions requiring medication
Active implanted medical devices like pacemakers or cochlear implants or metal in the neck/forearm that could interfere with stimulation or recordings
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Stimulation Session

Participants undergo acute electrical or ultrasound stimulation sessions versus sham

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after stimulation

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • External electrical stimulation
  • Ultrasound stimulation

Trial Overview

The study is testing two types of noninvasive stimulation—external electrical stimulation and ultrasound stimulation—to see how they affect the body in healthy adults.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Acute ultrasound stimulation session versus no stimulation (sham).Experimental Treatment1 Intervention
Group II: Acute electrical stimulation session versus no stimulation (sham).Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

Effects of electrical muscle stimulation on core ... - PMC - NIH

This study aimed to evaluate the immediate clinical effects of superimposing EMS on strength training compared with conventional exercise in healthy non- ...

Comparing the effects of 25-minute electrical muscle ...

Both EMS and TradRT were effective in improving strength and body composition, but TradRT led to greater strength development and fat reduction.

Title Electrical stimulation and muscle strength gains in ...

The investigative process was based on the premise of analyzing the methodological aspects and effectiveness of EMS on strength gains in healthy adults and ...

Effectiveness of Electrical Stimulation in Treating Upper ...

The results of this study found that e-stim shows promise in decreasing UE pain and improving UE function for older adult clients 65+ years old ...

Comparative Effectiveness of Electrical Stimulation and ... - PMC

In conclusion, this study indicated that electrical stimulation has been proven to be more effective than aerobic exercise in the treatment of individuals with ...

Is Electrical Stimulation Safe? - Anatomical Concepts

Explore the efficacy of electrical stimulation therapy for pain relief and muscle strengthening. Understand the safe usage of TENS units and ...

Electronic Muscle Stimulators

FDA has received reports of shocks, burns, bruising, skin irritation, pain, and interference with other critically important medical devices ( ...

Banned Devices; Electrical Stimulation Devices for Self- ...

Based on all available data and information, FDA has determined that the risk of illness or injury posed by ESDs for SIB or AB is substantial ...

Safety of long-term electrical peripheral nerve stimulation

Currently, chronic stimulation at frequencies below 30 Hz and percentages of effective stimulation time below 50% is considered safe, but more ...