Balance DisorderNCT04968197

Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

A study testing Vestibular Intervention via Portable Electrical Stimulator (VIPES) system in people with Balance Disorder, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to develop a vestibular interventional approach using stochastic vestibular stimulation (SVS) through a small, lightweight device, and a comfortable electrode set on the back of the head that stimulates the vestibular system and produces immediate improvements in balance, gait, and overall… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Balance Disorder
What is being tested?: Vestibular Intervention via Portable Electrical Stimulator (VIPES) system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2022to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must be able to consent to participate themselves.
Must be able to attend in-person sessions at the Mayo Aerospace Medicine and - Vestibular Research Laboratory in Scottsdale, AZ.
No racial/ethnic groups will be excluded.
All participants must be fluent speakers of English.

Who cannot join

Presence of peripheral vestibulopathy (cleared by Dix-Hallpike, vHIT as part of clinical evaluation).
Women who are pregnant.
Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259

Other trials in United States

About this study

Conditions: Balance Disorder
Being tested: Vestibular Intervention via Portable Electrical Stimulator (VIPES) system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vestibular Intervention via Portable Electrical Stimulator (VIPES) systemDevice
A small, lightweight device able to deliver stochastic vestibular stimulation (SVS) using a comfortable electrode set on the back of the head as well as other proven modes of galvanic vestibular stimulation (GVS) related vestibular correction when required to mitigate motion sickness or provide auxiliary vestibular cueing.

Study groups in NCT04968197
Study group	Role	What they receive
Stochastic Vestibular Stimulation (SVS) Condition	Experimental	Subjects will perform standard clinical testing for balance and gait while wearing the Vestibular Intervention via Portable Electrical Stimulator (VIPES) system. The SVS device will be active throughout the testing at the respective current levels (i.e., 0.2mA to 1 mA at 0.2 mA increments). Receives: Device: Vestibular Intervention via Portable Electrical Stimulator (VIPES) system
Control Condition	No intervention	Subjects will perform standard clinical testing for balance and gait without SVS

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Balance Performance
Change in balance performance during balance testing by measuring the center of gravity sway (degrees per second) across tested levels of GVR amplitude and control condition.
Measured: Through study completion, approximately 1.5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202231 Dec 2023

First posted20 Jul 2021
Study start1 Sep 2022
Primary completion16 Mar 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Balance DisorderStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04968197
Sponsor's protocol ID: 21-005284
Status last verified: May 2024
First submitted: 7 Jul 2021
Last updated: 13 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
ClinicalTrials.gov ID: NCT04968197
Acronym / sponsor ID: 21-005284
Conditions: Balance Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 1 Sep 2022 (actual)
Primary completion: 16 Mar 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 20 Jul 2021 (actual)
Results: Posted 13 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Stochastic Vestibular Stimulation (SVS) Condition	Experimental	Device: Vestibular Intervention via Portable Electrical Stimulator (VIPES) systemSubjects will perform standard clinical testing for balance and gait while wearing the Vestibular Intervention via Portable Electrical Stimulator (VIPES) system. The SVS device will be active throughout the testing at the respective current levels (i.e., 0.2mA to 1 mA at 0.2 mA increments).
Control Condition	No intervention	–Subjects will perform standard clinical testing for balance and gait without SVS

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participants must be able to consent to participate themselves.
Must be able to attend in-person sessions at the Mayo Aerospace Medicine and - Vestibular Research Laboratory in Scottsdale, AZ.
No racial/ethnic groups will be excluded.
All participants must be fluent speakers of English.

Key exclusion criteria (3 listed)

Presence of peripheral vestibulopathy (cleared by Dix-Hallpike, vHIT as part of clinical evaluation).
Women who are pregnant.
Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vestibular Intervention via Portable Electrical Stimulator (VIPES) systemA small, lightweight device able to deliver stochastic vestibular stimulation (SVS) using a comfortable electrode set on the back of the head as well as other proven modes of galvanic vestibular stimulation (GVS) related vestibular correction when required to mitigate motion sickness or provide auxiliary vestibular cueing.	Device	Stochastic Vestibular Stimulation (SVS) Condition

Primary outcome

Change in Balance Performance
Time frame: Through study completion, approximately 1.5 hours
Change in balance performance during balance testing by measuring the center of gravity sway (degrees per second) across tested levels of GVR amplitude and control condition.

Results and safety

Results posted to the registry on 13 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants Stochastic Vestibular Stimulation (SVS) and Control Condition	23	23

Primary outcome: Change in Balance Performance

Time frame: Through study completion, approximately 1.5 hours. Mean (Standard Deviation). Unit: degrees per second

Measure	Control Condition n = 23	0.33 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition n = 23	0.67 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition n = 23	1 Milliamps (mA)Stochastic Vestibular Stimulation (SVS) Condition n = 23
Eye Open Firm Surface	0.52 (0.84)	0.42 (0.34)	0.51 (0.79)	0.48 (0.57)
Eye Closed Firm Surface	0.63 (0.81)	0.55 (0.69)	0.73 (1.19)	0.58 (0.69)
Eye Open Foam Surface	0.91 (1.12)	0.73 (0.58)	0.87 (0.77)	0.76 (0.47)
Eye Closed Foam Surface	1.36 (0.97)	1.49 (1.58)	1.47 (1.23)	1.47 (1.32)

Adverse events

Time frame: Adverse events were collected from baseline to end of study participation for a total of approximately an hour and a half on all participants.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Condition	0 of 23 (0%)	0 of 23 (0%)	0 of 23
0.33 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition	0 of 23 (0%)	0 of 23 (0%)	0 of 23
0.67 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition	0 of 23 (0%)	0 of 23 (0%)	0 of 23
1 Milliamps (mA)Stochastic Vestibular Stimulation (SVS) Condition	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gaurav N Pradhan principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vestibular Intervention via Portable Electrical Stimulator (VIPES) system in people with Balance Disorder, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Balance Performance (time frame: Through study completion, approximately 1.5 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04968197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.