Noisy Electrical Vestibular Stimulation for Balance in Older Adults

JA
Overseen ByJordan A King, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
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 whether a gentle electrical treatment can improve balance when combined with an exercise program for older adults. The treatment, known as noisy electrical vestibular stimulation (nEVS), uses small electrical currents delivered through electrodes placed behind the ears and on the neck. Participants will be divided into two groups: one receiving active nEVS and the other receiving a sham treatment, which feels the same but doesn't deliver any current. The trial is suitable for adults aged 60 and older who can attend exercise classes and stand with their feet together for a minute. The main goal is to determine if this treatment improves balance, walking, and overall physical function. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance balance and physical function in older adults.

What prior data suggests that this method is safe for older adults?

Research has shown that noisy electrical vestibular stimulation (nEVS) is generally safe and well-tolerated by older adults. Studies have found that this treatment can improve balance in elderly people without causing serious side effects. For instance, one study discovered that nEVS improved balance while standing, and these benefits lasted for several hours after the treatment. This indicates that the treatment is not only effective but also safe for older adults, with no major negative effects reported.12345

Why are researchers excited about this trial?

Most treatments for balance issues in older adults focus on exercises or medications to manage symptoms. However, noisy electrical vestibular stimulation (nEVS) works differently by using gentle electrical signals to stimulate the vestibular system, which helps control balance and spatial orientation. This method is unique because it may enhance balance without the need for drugs, offering a non-invasive and potentially safer option. Researchers are excited about nEVS as it could provide a new way to improve balance and reduce fall risk in older adults, potentially leading to better quality of life.

What evidence suggests that noisy electrical vestibular stimulation is effective for improving balance in older adults?

Research has shown that noisy electrical vestibular stimulation (nEVS) might improve balance in older adults. Several studies have found that nEVS can enhance stability, helping to prevent falls. This trial will compare active subthreshold stochastic electrical vestibular stimulation with a sham version. The active treatment sends small electrical currents behind the ears, aiding the body's interpretation of balance signals. Evidence suggests that nEVS is safe and could lead to lasting improvements in balance. Overall, nEVS appears to be a promising approach to addressing age-related balance issues.678910

Who Is on the Research Team?

RM

Ryan M Peters, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults aged 60 and older who want to improve their balance. People with certain medical devices, skin issues near the electrode sites, or other health problems that could interfere may not be able to join.

Inclusion Criteria

I can safely join an adapted exercise program, using aids or modifications if needed.
I can understand the study and give my consent to participate.
I can walk up to 200 metres on a flat surface.
See 3 more

Exclusion Criteria

Pacemaker, cochlear implant or another implanted electronic device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham noisy electrical vestibular stimulation (nEVS) for 6 weeks, alongside the RISE STRONG exercise program

6 weeks
3 visits per week (in-person)

Exercise Program

Participants attend the RISE STRONG exercise program, which includes strength, balance, and mobility exercises

12 weeks
2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of balance, gait speed, and other physical functions

6 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Noisy electrical vestibular stimulation

Trial Overview

The study compares a low-level electrical stimulation treatment (nEVS) applied behind the ears and neck versus a sham (inactive) device. Both groups also participate in a supervised exercise program for 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active subthreshold stochastic electrical vestibular stimulationExperimental Treatment1 Intervention
Group II: Sham electrical vestibular stimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Neursantys Inc

Industry Sponsor

Trials
1
Recruited
500+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41174737/

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