Noise Stimulation for Aging

Recruiting at 1 trial location

Overseen By Stephanie G Iring-Sanchez, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: Psychotic medications

Disqualifiers: Diabetes, Stroke, Seizure, others

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

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new electronic stimulation device to determine if it can help older adults walk faster and improve balance. Participants will use the device during tasks like walking and standing to assess its effectiveness. Suitable candidates are individuals aged 21 and older who do not have major health issues and can stand and walk unassisted. The primary treatment under investigation is called Subperceptual Stimulus, with a Sham Comparator (placebo) group for comparison. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mobility and balance for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on psychotic medications or have certain health conditions, you may not be eligible to participate.

What prior data suggests that this electronic stimulation device is safe for improving balance in older individuals?

Research has shown that the gentle electrical stimulation tested in this study is generally safe for older adults. Participants in studies have tolerated these low levels of electrical stimulation well, with no major side effects reported. The stimulation is designed to be so mild that it should not cause any sensation or discomfort. This method has been examined for its potential to improve balance and reduce the risk of falls in older people. Overall, evidence suggests it is a safe and well-tolerated option for older individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to potentially enhance mobility in aging individuals through subperceptual electrical stimulation. Unlike traditional treatments that might focus on physical therapy or medication to improve gait and balance, this approach uses tiny electrical impulses that you don't even feel to fine-tune the body's balance and movement systems. The key innovation here is its precision in optimizing stimulus levels to achieve the greatest improvement in gait, potentially offering a non-invasive, low-risk alternative to existing methods. By targeting the body's natural reflexes and movements directly, this technique could open new doors for improving quality of life in older adults without the side effects of pharmaceuticals.

What evidence suggests that this device is effective for improving balance in older individuals?

Research has shown that gentle electrical stimulation can help older adults improve their balance and walking speed. In this trial, participants will receive either a subperceptual stimulus or a sham comparator. Studies have found that applying this type of stimulation to the inner ear's balance system can enhance its function. People who tried this treatment noticed better walking patterns that continued even after the sessions ended. This suggests that the device might help older individuals walk faster and more steadily. The treatment gently stimulates the nerves responsible for balance, which seems to improve their performance. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults with balance issues due to Peripheral Vestibular Disease or other vestibular disorders. Participants should be able to perform tasks like walking for six minutes and standing on a foam block. Those with conditions that might interfere with the study or who cannot follow its procedures are not eligible.

Inclusion Criteria

I am between 21-59 or 60+ years old with no major health issues.

Exclusion Criteria

Recent history of alcohol or drug abuse within the past 6 months

I have had serious eye issues in the past.

History of implanted electronic devices (pacemakers, defibrillators, implanted pumps or stimulator devices, cochlear, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants perform tasks while wearing the stimulation device to assess improvements in balance and gait

2 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Sham Comparator
• Subperceptual Stimulus

Trial Overview The study tests a new device, similar to TENS, designed to improve balance and gait in individuals with reduced balance function. It involves wearing the device while performing various tasks such as walking and standing under different conditions.

How Is the Trial Designed?

Group I: Stim Experimental Treatment 1 Intervention

Three different methods will be used to determine the level of stimulation that produces the greatest improvement in gait. The basic concept is that to determine the optimal level of stimulus the investigators apply various levels of random subperceptual electrical stimulation while measuring either vestibular ocular reflex, static sway or gait. Then the investigators will compare the performance of the selected variable at each level of stimulation to determine which amount of stimulation produced the greatest improvement in the selected variable. Once that is determined

Group II: Sham Placebo Group 1 Intervention

During each testing session there will be a sham and stimulation trial of each test. The order of the sham/stim trials will be randomized.

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

University of Western Sydney

Collaborator

Trials

21

Recruited

2,700+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11381316

Project Details - NIH RePORTER Recently, we have found that subperceptual levels of random electrical stimulation applied to the vestibular system produce improvements in vestibular-mediated ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06688578

Testing Effectiveness of a Stochastic Noise Stimulator to ... The overall purpose of this study is to investigate whether low level (sub-perceptual) electrical stimulation produces improvements in vestibular function ( ...

3. nature.com nature.com/articles/s41598-017-18653-8

Enhancing vestibular function in the elderly with ... Since we expected the OCR gains to be lower in the elderly, we hypothesized this group would show greater improvements with the SN intervention.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7410845/

Non-invasive peripheral nerve stimulation selectively ... Vagus nerve stimulation has been shown to prime adult sensory-perceptual systems towards plasticity in animal models. Precise temporal pairing ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X20300413

Electrical stimulation of cranial nerves in cognition and ... Several papers have reported improvements in gait that outlasted the stimulation sessions, sometimes by months [283,286]. Based on the reported sustained ...

6. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/dad2.12340

Stronger implicit interference in cognitively healthy older ... We measured implicit interference elicited by an imperceptible distractor in cognitively healthy elderly participants with normal (low risk) and pathological ( ...

7. frontiersin.org frontiersin.org/journals/synaptic-neuroscience/articles/10.3389/fnsyn.2020.00034/full

Psychedelics as a Treatment for Alzheimer's Disease ... This mini-review will explore the role of classical psychedelics psilocybin and Lysergic acid diethylamide (LSD) in treating AD with a focus on sub-perceptual- ...

8. researchgate.net researchgate.net/publication/322367578_Enhancing_vestibular_function_in_the_elderly_with_imperceptible_electrical_stimulation

(PDF) Enhancing vestibular function in the elderly with ... Age-related loss of vestibular function can result in decrements in gaze stabilization and increased fall risk in the elderly. This study was designed to ...

9. nature.com nature.com/articles/s41539-020-0070-0

Non-invasive peripheral nerve stimulation selectively ... Vagus nerve stimulation has been shown to prime adult sensory-perceptual systems towards plasticity in animal models. Precise temporal pairing ...