Trial Outcomes & Findings for Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness (NCT NCT02048670)
NCT ID: NCT02048670
Last Updated: 2019-05-15
Results Overview
The Sensory Organization Test is a six condition standard evaluation of balance control performed on a dynamic platform that can record sway movement in the A/P dimension while the sensory inputs from proprioception and vision are varied though the platform and visual surround movements. Condition 1 - eyes open, visual locked, platform locked. Condition 2 - eyes closed, visual locked, platform locked. Condition 3 - eyes open, visual unlocked, platform locked. Condition 4 - eyes open, visual locked, platform unlocked. Condition 5 - eyes closed, visual locked, platform unlocked. Condition 6 - eyes open, visual unlocked, platform unlocked. All participants progress though the exam, starting with condition 1 and ending with condition 6. All conditions were completed two to three times depending on performance with the average of each condition reported.
COMPLETED
NA
12 participants
baseline
2019-05-15
Participant Flow
Participant milestones
| Measure |
Chronic Subjective Dizziness Syndrome Subjects
Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.
|
Healthy Subjects
Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Chronic Subjective Dizziness Syndrome Subjects
n=6 Participants
Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.
|
Healthy Subjects
n=6 Participants
Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 12.2 • n=6 Participants
|
56.3 years
STANDARD_DEVIATION 11.6 • n=6 Participants
|
56.4 years
STANDARD_DEVIATION 11.3 • n=12 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: baselineThe Sensory Organization Test is a six condition standard evaluation of balance control performed on a dynamic platform that can record sway movement in the A/P dimension while the sensory inputs from proprioception and vision are varied though the platform and visual surround movements. Condition 1 - eyes open, visual locked, platform locked. Condition 2 - eyes closed, visual locked, platform locked. Condition 3 - eyes open, visual unlocked, platform locked. Condition 4 - eyes open, visual locked, platform unlocked. Condition 5 - eyes closed, visual locked, platform unlocked. Condition 6 - eyes open, visual unlocked, platform unlocked. All participants progress though the exam, starting with condition 1 and ending with condition 6. All conditions were completed two to three times depending on performance with the average of each condition reported.
Outcome measures
| Measure |
Chronic Subjective Dizziness Syndrome Subjects
n=6 Participants
Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.
|
Healthy Subjects
n=6 Participants
Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.
|
|---|---|---|
|
Degrees of Sway
Condition 1
|
1.824 degrees of sway
Standard Error 0.266
|
0.746 degrees of sway
Standard Error 0.278
|
|
Degrees of Sway
Condition 2
|
1.638 degrees of sway
Standard Error 0.259
|
0.573 degrees of sway
Standard Error 0.287
|
|
Degrees of Sway
Condition 3
|
1.605 degrees of sway
Standard Error 0.252
|
0.869 degrees of sway
Standard Error 0.278
|
|
Degrees of Sway
Condition 4
|
1.480 degrees of sway
Standard Error 0.259
|
1.979 degrees of sway
Standard Error 0.259
|
|
Degrees of Sway
Condition 5
|
1.900 degrees of sway
Standard Error 0.270
|
1.892 degrees of sway
Standard Error 0.278
|
|
Degrees of Sway
Condition 6
|
1.519 degrees of sway
Standard Error 0.274
|
2.666 degrees of sway
Standard Error 0.274
|
SECONDARY outcome
Timeframe: baselinePopulation: This outcome measure was not evaluated in this study. No data have been collected for this outcome measure.
For the therapy portion of the study aim #2 Visual Analog Scales (VAS) related to the intensity of symptoms provoked by visual motion, head movements and walking in visually complex environments. The average Visual Analog Scale scores for the patient group pre and post therapy will be compared for any significant difference in the score (p\<0.05). The VAS ranges from 0-10, where 0 is no symptoms and 10 is the most intense symptoms experienced.
Outcome measures
Outcome data not reported
Adverse Events
Chronic Subjective Dizziness Syndrome Subjects
Healthy Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place