Testing an Intraoral Electronic Balance Aid for Vestibular Imbalance

Not Applicable

Terminated

• Conditions: Vestibular Disorder
• Interventions: Device: EquiCue (Intraoral Electronic Balance Aid)

• Registration Number: NCT02735096
• Lead Sponsor: Innervo Technology LLC

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.

Detailed Description

Background

Vestibular imbalance is prevalent in the United States and around the world. According to NIDCD, 4% (8 million) of American adults report a chronic problem with balance (visit vestibular.org for more information). The leading cause of imbalance is vestibular dysfunction. Various vestibular disorders due to aging, diseases, ototoxicity, and injuries, etc. can cause damage or degradation of the vestibular system, resulting in loss of vestibular feedback. Symptoms associated with vestibular loss include: difficulty maintaining straight posture; stumbling or unable to walk straight; lose balance on uneven surfaces or under dim lighting; floating sensation and tendency to look downward to confirm the location of the ground. Vestibular imbalance greatly increases risk of falling and has such disabling effects ranging from reduced activity levels to total loss of mobility.

Vestibular rehabilitation therapies (VRT) may help vestibular patients to compensate with vision and proprioception. However, such compensation is not adequate because the brain often needs a reliable reference in order to use visual and somatosensory information for perception of self-motion and spatial orientation. Consequently, many patients with vestibular imbalance fail to compensate, especially those with profound vestibular loss. Even those who respond to VRT may experience constant physical and mental stress due to overreliance on vision and proprioception that can be misleading in busy environments.

EquiCue™ Intraoral Balance Aid

The intraoral balance aid EquiCue™ V1 is a hidden and noninvasive balance device that vestibular patients can use in various indoor and outdoor activities. It is a retainer-like device entirely worn inside the oral cavity, with no need of surgical implantation, and can be removed when not in use. The device provides in-situ sensory feedback of head tilt and motion by applying small electrical pulses on the roof of the mouth. By sensing the feedback from the device, an individual with vestibular loss can have better judgment of the tilt and motion of the head and make physical adjustment accordingly for better balance of the body. Since the device does not cause alteration to the appearance of the user, patients may use it in public places such as shopping malls, supermarkets, and metro stations, while offering balance assistance and improved postural stability and gait in these busy environments.

Human Subject Study

The current study is an initial stage of a clinical trial on the use of EquiCue™ for patients with vestibular imbalance. The hypothesis is that EquiCue™ can at least partially substitute the lost vestibular function and therefore helps a vestibular patient to achieve better postural stability in daily activities. The basic questions regarding the technology are: 1) How to represent head movement using electrical pulses on the palate; 2) Whether the electrotactile presentation on the palate can be reliably recognized and used for balance control. The study also helps to understand the role of multisensory integration on balance, especially the impact of alternative sensory feedback on the balance system.

Subjects participating in the study will be expected to wear a custom-made retainer-like device and perform movements to test their balance. If a patient is determined to be a suitable subject, the sensitivity profile on the palate of the patient will be measured. After an EquiCue™ intraoral device is custom made, the patient will be asked to fit the device inside the mouth, and verify the basic functionality of the device by identifying direction, perceived intensity, and sensory characteristics of stimuli from the device. The subject will then go through 3-4 sessions of training and testing in which the subject tries to associate the feedback with head movement and to integrate the feedback with other senses to achieve a better spatial orientation and balance. The improvement in balance and gait with the device will be evaluated by using standard tests on balance platforms (Computerized Dynamic Posturography) and Dynamic Gait Index. Tests will be made without wearing the device at the beginning and wearing the device at the end of each training session.

Study Timeline

• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Study Start: 2016-07
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2018-03
• Results First Submitted: 2018-03-15
• Results First Submitted QC: 2019-04-04
• Last Update Submitted: 2019-04-04
• Results First Posted: 2019-04-08
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vestibular Patients for EquiCue Testing	EquiCue (Intraoral Electronic Balance Aid)	Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance.

Primary Outcome Measures

Name	Time	Method
Equilibrium Score	July 2016 - October 2016 (~ 4 months)	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.

Secondary Outcome Measures

Name	Time	Method
Analog Visual Scale for the Perceived Frequency of Stimulation Pulses	July 2016 - October 2016 (~ 4 months)	A patient's assessment of the speed of pulses to quantify perceptual difference in the pulse frequencies of the feedback on the palatal surface.
Perceived Intensity Level	July 2016 - October 2016 (~ 4 months)	The perceived Intensity level (from 0 to 5) as judged by a patient in response to pulsed stimuli applied on the palatal surface after adjustment of device settings for that patient. 1 - barely perceptible, 2 - weak, 3 - good, 4 - strong, 5 - painful.
Dynamic Gait Index	July 2016 - October 2016 (~ 4 months)	A subject's gait is evaluated by a physical therapist when no device is worn and when alternative sensory feedback of head movement is presented to the patient using the device. 7 walking exercises were administrated for each DGI test, with a score in the range of 0 - 3 (0 for severely impaired and 3 for normal gait) for each exercise, and a total score in the range of 0 - 21 for each test.

Trial Locations

Locations (2)

MU ENT Hearing and Balance Center; 🇺🇸 Columbia, Missouri, United States

Blue Ridge Physical Therapy; 🇺🇸 Independence, Missouri, United States