Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

Mayo Clinic

Status: Completed

Conditions: Dizziness Chronic

Treatments: Device: Balance Belt

Study type: Interventional

Funder types: Other

Identifiers

NCT02048670

13-005525

Details and patient eligibility

About

Researchers are gathering information on the safety and effectiveness of a new device called the BalanceBelt.

Full description

Ten consecutive subjects, ages 25-70 years, diagnosed with Chronic Subjective Dizziness (CDS) and ten healthy age and gender matched subjects will be asked to perform tests involving walking and balance while wearing the BalanceBelt. The BalanceBelt is a lightweight belt that will be worn under the clothes around the subjects waist and uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and motion.

Enrollment: 12 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Chronic Subjective Dizziness Syndrome Subjects

Experimental group

Description:

Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.

Treatment:

Device: Balance Belt

Healthy Subjects

Active Comparator group

Description:

Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.

Treatment:

Device: Balance Belt