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

Trial Summary

What is the purpose of this trial?

The goal of this intervention study is to determine if a new electronic stimulation device, similar to a TENS can improve balance and make walking easier in older individuals with reduced balance function. The main question aims to answer the following: Can using the device improve walking speed in older individuals? Participants will be asked to perform a number of tasks while wearing the device: Walk for 6 minutes * Stand in place while having balance measured (eyes open and closed) * Stand on a foam block while having balance measured (eyes open and closed) * Sit in a chair that will tilt +/- 20 degrees while wearing goggles that take videos of the participants eyes.

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 data supports the effectiveness of the treatment Sham Comparator, Placebo, Control Group, Subperceptual Stimulus for aging?

The research suggests that older adults have increased difficulty processing sensory information, such as visual and auditory stimuli, due to age-related changes in the brain. This implies that treatments targeting sensory processing, like noise stimulation, might help improve perceptual processing in aging individuals by potentially enhancing the brain's ability to filter and integrate sensory information. ^{1 2 3 4 5}

Is noise stimulation safe for older adults?

Visual and acoustic interventions like white noise are generally considered safe and have minimal side effects, but older adults may experience increased cardiovascular reactivity, which could pose a risk. More research is needed to fully understand the long-term effects of noise stimulation on the elderly. ^{1 6 7 8 9}

How does the treatment Subperceptual Stimulus differ from other treatments for aging?

Subperceptual Stimulus is unique because it involves using noise stimulation, which may help improve sensory processing in aging individuals by targeting the brain's ability to adapt to sensory input. This approach is different from traditional treatments that might focus on medication or physical therapies, as it aims to enhance neural processing efficiency and adaptability. ^{1 7 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Age differences in backward dichoptic masking. [2008]

2. Italy pubmed.ncbi.nlm.nih.gov

The effect of eye disease, cataract surgery and hearing aid use on multisensory integration in ageing. [2021]

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

Decreased Modulation of Population Correlations in Auditory Cortex Is Associated with Decreased Auditory Detection Performance in Old Mice. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Masked speech perception across the adult lifespan: Impact of age and hearing impairment. [2018]

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

Brain aging and speech perception: Effects of background noise and talker variability. [2021]

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

Phasic alertness cues modulate visual processing speed in healthy aging. [2019]

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

Reduction in direction discrimination with age and slow speed is due to both increased internal noise and reduced sampling efficiency. [2021]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Visual and acoustic interventions for improving mental health in advanced age.] [2022]

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

Age differences in cardiovascular and cognitive performance under noise conditions. [2008]

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

Aging Affects Adaptation to Sound-Level Statistics in Human Auditory Cortex. [2020]

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

Differences in chromatic noise suppression of luminance contrast discrimination in young and elderly people. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Contrast sensitivity, healthy aging and noise. [2019]