Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-005525
NCT ID: NCT02048670
Sponsor Protocol Number: 13-005525
About this study
This pilot study is focused on what assistance an external prosthetic device, the BalanceBelt™ can provide in the:
- assessment and
- treatment for patients with Chronic Subjective Dizziness (CSD).
The BalanceBelt has sensitive detectors for movement in the anterior/posterior and medial/lateral planes and provides the person wearing the device vibro-tactile feedback as to the persons orientation with respect to gravity. The device is a full self contained device that is comfortably worn around the waist over a light weight shirt. The device is non-FDA approved and is in its final stages of beta testing. Patients with CSD do not have permanent vestibular deficits, but underutilize vestibular signals because they develop visual or somatosensory dependence. The investigators expect the BalanceBeltTM to reset this error by providing patients with reliable motion stimuli.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jeffrey Staab, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available