Recruiting

Electronic Stimulation

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT06688578

Conditions

Vestibular Disorder

Aging

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Subperceptual Stimulus

Sham Comparator

Study Details

Brief summary:

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.

Conditions

Vestibular Disorder

Aging

Study ID

NCT06688578

Start date

Sep 25, 2026

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria Older (ages 60+) and younger (aged 21-59) participants with no significant health history will be recruited from the community.

Exclusion Criteria

Any person with a self-reported history of:

  • impaired proprioception
  • significant eye problems
  • neuromuscular disease
  • seizure
  • stroke
  • unmedicated diabetes
  • cardiovascular disease (except controlled hypertension)
  • renal disease or electrolyte imbalance
  • orthopedic disorders such as severe neck or back pain
  • uncontrolled high blood pressure (200/110 or greater)
  • implanted electronic devices (pacemakers, defibrillators, implanted pumps or stimulator devices, cochlear, etc.)
  • psychotic medications or current psychotic symptoms
  • Any other psychiatric condition requiring hospitalization since 1991
  • recent history of alcohol or drug abuse within the past 6 months
  • inability to stand unassisted for 30 seconds or walk unassisted for 6 minutes

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham

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.

experimental: Stim

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

Interventions

Subperceptual Stimulus

For each test participants will be stimulated using a subperceptual electric signal that is optimized to improve their gait.

Sham Comparator

During intervention trial, sham comparator will consist of same stimulation device but no actual electrical stimulation will be provided by device during intervention trial.

Primary outcome measure

  • Gait velocity [ Time Frame: From enrollment to the end of the intervention (2 days) ]

Central Contacts and Locations

Central contacts

Jorge M Serrador, PhD

6177949341jserrador@meei.harvard.edu

Stephanie G Iring-Sanchez, PhD

2019701966siring-sanchez@meei.harvard.edu

Locations

Massachusetts Eye and Ear, Harvard Medical School

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Stephanie G Iring-Sanchez, PhD

2019701966siring-sanchez@meei.harvard.edu

Jorge Serrador

jserrador@meei.harvard.edu

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Balance and Gait
  • Stochastic Noise Stimulator
  • Neural degeneration
  • neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-06-23.