N/A
Completed N=12
Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness
Dizziness Chronic
Source: ClinicalTrials.gov NCT02048670 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Degrees of Sway — 1.824; 0.746; 1.638; 0.573 degrees of sway — p=0.005
Summary
Researchers are gathering information on the safety and effectiveness of a new device called the BalanceBelt.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degrees of Sway |
1.824; 0.746; 1.638; 0.573; 1.605; 0.869 | 0.005 sig |
| SECONDARY Visual Analog Scales Score |
— | — |
Eligibility Criteria
Subject population: 20 patients with diagnosis of Chronic Subjective Dizziness (CSD) and 10 normal volunteers.
Inclusion Criteria
- Subjects will be 25-70 years of age inclusive and pregnant women may participate.
- Patients will have CSD as their primary diagnosis for the cause of their balance and dizziness complaints provided by the Behavioral Medicine Program for Dizziness, a division of the Department of Psychiatry & Psychology.
- Normal volunteers will have a negative history of otologic & neurologic disorders and no history of dizziness and balance problems.
- Normal volunteers will have normal findings on a screening office examination for peripheral and central vestibular system involvement (see methods for details of the examination) and screening for normal or symmetrical hearing loss of explainable origin.
Exclusion Criteria
- Patients with positive indications from testing of peripheral and/or central vestibular system involvement that is felt to be influencing the symptoms reported beyond the CSD alone.
- Patients with mobility restriction that would prevent participating in the tests or the intensive therapy trials.
- Subjects with hearing impairment that interferes with oral communication.
Data sourced from ClinicalTrials.gov (NCT02048670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.