N/A N=12 Treatment

Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

Dizziness Chronic

Bottom Line

View on ClinicalTrials.gov: NCT02048670 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Degrees of Sway — 1.824; 0.746; 1.638; 0.573 degrees of sway — p=0.005

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Balance Belt (Device)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jul 2017

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	—	—

Summary

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

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.

View full record on ClinicalTrials.gov →

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.