Testing Effectiveness of a Stochastic Noise Stimulator to Immediately Improve Balance and Gait
Improvements in Balance and Gait Using a Stochastic Noise Stimulator: Short Term Response
2 other identifiers
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedStudy Start
First participant enrolled
February 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
January 27, 2026
January 1, 2026
3 months
November 6, 2024
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gait velocity
Gait will be measured with a set of motion sensors (Xsens MTw Awinda motion sensors). These wearable inertial monitors measure rotational rate, acceleration, magnetic field strength, and temperature. The sensors are about the size of a watch and attach with Velcro bands. The sensors are wirelessly synchronized with each other and the software, eliminating interconnecting cables and minimizing risk of falling. Gait measures will include gait velocity, gait variability, gait synchronization.
From enrollment to the end of the intervention (2 days)
Secondary Outcomes (5)
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
From enrollment to the end of the intervention (2 days)
Ocular Torsion
From enrollment to the end of the intervention (2 days)
Video Head Impulse Testing (vHIT)
From enrollment to the end of the intervention (2 days)
Instrumental Timed Up and Go Test (TUG)
From enrollment to the end of the intervention (2 days)
Functional Gait Assessment (FGA)
From enrollment to the end of the intervention (2 days)
Study Arms (2)
Sham
SHAM COMPARATORDuring each testing session there will be a sham and stimulation trial of each test. The order of the sham/stim trials will be randomized.
Stim
EXPERIMENTALThree 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
During intervention trial, sham comparator will consist of same stimulation device but no actual electrical stimulation will be provided by device during intervention trial.
For each test participants will be stimulated using a subperceptual electric signal that is optimized to improve their gait.
Eligibility Criteria
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts Eye and Ear Infirmarylead
- University of Western Sydneycollaborator
- National Institute on Aging (NIA)collaborator
- Johns Hopkins Universitycollaborator
Study Sites (2)
Johns Hopkins Medicine
Baltimore, Maryland, 21218, United States
Massachusetts Eye and Ear, Harvard Medical School
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Masked individuals will not know if sham or stim; 1. Participants will be masked. 2. The Post-doc/Research Coordinator running the study will be masked.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
November 6, 2024
First Posted
November 14, 2024
Study Start
February 25, 2026
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
January 27, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Upon completion of the study and ending 3 years after the publications of results
- Access Criteria
- Email the principal investigator (jserrador@meei.harvard.edu)
As part of an sIRB agreement, data may be sent to grant research collaborators (Dr. Michael Schubert) at Johns Hopkins School of Medicine to aid in analysis and pursuance of study aims. All data will be de-identified and may include questionnaire results, balance, gait, eye movement data (i.e., OCR and vHIT), and stimulus parameters. Data will be shared with collaborators via current RISO-approved secure methods including REDCap, Veeva, Secure File Transfer, and MGB Dropbox. Clinical data (without any personal identifiers) will be available upon request to the principal investigator (Dr. Jorge Serrador) upon completion of the study.