Testing an Intraoral Electronic Balance Aid for Vestibular Imbalance

Stopped early · Not applicable

Conditions studied: Vestibular Disorder

In brief

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.

Key facts

Study ID

NCT02735096

Run by

Innervo Technology LLC

People needed

4

Starts

2016-07-01

Expected to finish

2016-10-01

Last updated by the study team

2019-04-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• MU ENT Hearing and Balance Center — Columbia, Missouri, United States
• Blue Ridge Physical Therapy — Independence, Missouri, United States

Full record on ClinicalTrials.gov

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