Trial Outcomes & Findings for Testing an Intraoral Electronic Balance Aid for Vestibular Imbalance (NCT NCT02735096)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

July 2016 - October 2016 (~ 4 months)

Results posted on

2019-04-08

Participant Flow

Single group, recruited at MU balance clinic

Patient with full denture was excluded

Participant milestones

Participant milestones
Measure	Patients Diagnosed With Vestibular Dysfunction Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance. EquiCue (Intraoral Electronic Balance Aid): 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.
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Diagnosed With Vestibular Dysfunction Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance. EquiCue (Intraoral Electronic Balance Aid): 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.
Overall Study No symptoms in clinic/personal leave	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Diagnosed With Vestibular Dysfunction n=4 Participants Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance. EquiCue (Intraoral Electronic Balance Aid): 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.
Age, Categorical <=18 years	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=4 Participants
Region of Enrollment United States	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: July 2016 - October 2016 (~ 4 months)

Population: One patient did not have any symptoms during clinical visits, and she did not finish the three test sessions for balance and DGI. Her results were excluded for comparison. The remaining participants included one male and two females.

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.

Outcome measures

Outcome measures
Measure	Patients Diagnosed With Vestibular Dysfunction n=3 Participants Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance. EquiCue (Intraoral Electronic Balance Aid): 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.
Equilibrium Score Equilibrium score without device	63 score on a scale Standard Deviation 4.97
Equilibrium Score Equilibrium with device	69.67 score on a scale Standard Deviation 9.88

SECONDARY outcome

Timeframe: July 2016 - October 2016 (~ 4 months)

Population: Even though 1 patient did not show any symptoms during clinical visits, all 4 patients each had a device custom made and tested for perceived intensity levels.

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.

Outcome measures

Outcome measures
Measure	Patients Diagnosed With Vestibular Dysfunction n=4 Participants Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance. EquiCue (Intraoral Electronic Balance Aid): 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.
Perceived Intensity Level	2.91 units on a scale Standard Deviation 0.12

SECONDARY outcome

Timeframe: July 2016 - October 2016 (~ 4 months)

Population: One patient did not show any symptoms during clinical visits, and her DGIs were excluded for comparison.

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.

Outcome measures

Outcome measures
Measure	Patients Diagnosed With Vestibular Dysfunction n=3 Participants Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance. EquiCue (Intraoral Electronic Balance Aid): 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.
Dynamic Gait Index DGI score without device	17.22 score on a scale Standard Deviation 2.80
Dynamic Gait Index DGI score with device	19.11 score on a scale Standard Deviation 3.00

SECONDARY outcome

Timeframe: July 2016 - October 2016 (~ 4 months)

Population: This test process was not performed for patients with vestibular dysfunction as it is such a tedious process that it is not practical for a patient with dizziness to complete.

A patient's assessment of the speed of pulses to quantify perceptual difference in the pulse frequencies of the feedback on the palatal surface.

Outcome measures

Outcome data not reported

Adverse Events

Patients Diagnosed With Vestibular Dysfunction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hui Tang

Innervo Technology

Phone: 5732896776

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place