NCT02735096

Brief Summary

The human body uses vestibular feedback in coordination with visual and somatosensory information to maintain balance and posture. However, various inner-ear disorders due to aging, drug toxicity, viral infections, and injury, etc., may result in loss of vestibular feedback, which makes it difficult for an individual to maintain balance. This study investigates the use of a hidden and noninvasive balance device EquiCue™ V1 developed by Innervo Technology for vestibular substitution. EquiCue™ V1 is a retainer-like intraoral electronic balance aid entirely worn inside the oral cavity and provides in-situ sensory feedback of head tilting and motion on the roof of the mouth. The feedback is delivered by applying small and controlled electrical pulses at precise locations on the palatal surface according to an encoded pattern. This pilot study is to determine how this alternative sensory feedback on the roof of the mouth can be used to improve balance for patients with vestibular loss.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 8, 2019

Completed
Last Updated

April 8, 2019

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

March 30, 2016

Results QC Date

March 15, 2018

Last Update Submit

April 4, 2019

Conditions

Vestibular Disorder

Keywords

Bilateral Vestibular HypofunctionUnilateral Vestibular HypofunctionImbalance

Outcome Measures

Primary Outcomes (1)

  • Equilibrium Score

    Equilibrium scores for each trial for each condition from Sensory Organization Test (EquiTest). Conditions: 1-6; with or without using EquiCue intraoral balance aid. Equilibrium scores were generated from the EquiTest CDP (computerized dynamic posturography) platform to assess standing balance of a patient ranging from 0 (all falls) to 100 (perfect balance with no sway), with higher scores indicating better balance performance. An equilibrium score of 70 and above is considered normal.

    July 2016 - October 2016 (~ 4 months)

Secondary Outcomes (3)

  • Perceived Intensity Level

    July 2016 - October 2016 (~ 4 months)

  • Dynamic Gait Index

    July 2016 - October 2016 (~ 4 months)

  • Analog Visual Scale for the Perceived Frequency of Stimulation Pulses

    July 2016 - October 2016 (~ 4 months)

Study Arms (1)

Vestibular Patients for EquiCue Testing

EXPERIMENTAL

Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance.

Device: EquiCue (Intraoral Electronic Balance Aid)

Interventions

EquiCue (Intraoral Electronic Balance Aid)DEVICE

When the device is worn, a subject will receive small electrical pulses on roof of the mouth as alternative feedback of head tilting or movement.

Also known as: EquiCue
Vestibular Patients for EquiCue Testing

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking adults with ages between 18-85.
  • Patients with imbalance resulted from vestibular loss or vestibulopathy.
  • Priority given to those who took vestibular rehabilitation therapy but without satisfactory improvement.

You may not qualify if:

  • Inability to follow instructions.
  • Any visible abnormalities on the hard palate that prevent use of the palatal device.
  • Any mental or physical illness beyond the secondary effects of vestibular loss that prevent recognition or effective use of the alternative feedback.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MU ENT Hearing and Balance Center

Columbia, Missouri, 65201, United States

Location

Blue Ridge Physical Therapy

Independence, Missouri, 64055, United States

Location

Related Publications (7)

  • Tang H, Beebe DJ. An oral tactile interface for blind navigation. IEEE Trans Neural Syst Rehabil Eng. 2006 Mar;14(1):116-23. doi: 10.1109/TNSRE.2005.862696.

    PMID: 16562639BACKGROUND

  • Tang H; Beebe DJ. Design and microfabrication of a flexible oral electrotactile display. Journal of Microelectromechanical Systems. 2003 Feb;12(1):29-36.

    BACKGROUND

  • Danilov YP, Tyler ME, Skinner KL, Hogle RA, Bach-y-Rita P. Efficacy of electrotactile vestibular substitution in patients with peripheral and central vestibular loss. J Vestib Res. 2007;17(2-3):119-30.

    PMID: 18413905BACKGROUND

  • Dozza M, Horak FB, Chiari L. Auditory biofeedback substitutes for loss of sensory information in maintaining stance. Exp Brain Res. 2007 Mar;178(1):37-48. doi: 10.1007/s00221-006-0709-y. Epub 2006 Oct 5.

    PMID: 17021893BACKGROUND

  • Wall C 3rd, Merfeld DM, Rauch SD, Black FO. Vestibular prostheses: the engineering and biomedical issues. J Vestib Res. 2002-2003;12(2-3):95-113.

    PMID: 12867668BACKGROUND

  • Brown KE, Whitney SL, Wrisley DM, Furman JM. Physical therapy outcomes for persons with bilateral vestibular loss. Laryngoscope. 2001 Oct;111(10):1812-7. doi: 10.1097/00005537-200110000-00027.

    PMID: 11801950BACKGROUND

  • Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.

    PMID: 19468085BACKGROUND

Related Links

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Dr. Hui Tang
Organization
Innervo Technology
htang@innervotech.com
5732896776

Study Officials

  • Hui Tang, Ph.D

    Innervo Technology LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 12, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

April 8, 2019

Results First Posted

April 8, 2019

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

Participants' age and history of illness (i.e., vestibular loss) will be shared. However, no personal identifiable information will be collected and shared.

Locations

US(2)