Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness (NCT02048670) | Clinical Trial Compass
CompletedNot Applicable
Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness
United States12 participantsStarted 2014-10
Plain-language summary
Researchers are gathering information on the safety and effectiveness of a new device called the BalanceBelt.
Who can participate
Age range25 Years – 70 Years
SexALL
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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.