MedPath

Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

Not Applicable
Completed
Conditions
Dizziness Chronic
Interventions
Device: Balance Belt
Registration Number
NCT02048670
Lead Sponsor
Mayo Clinic
Brief Summary

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

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Chronic Subjective Dizziness Syndrome SubjectsBalance BeltSubjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.
Healthy SubjectsBalance BeltAge matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.
Primary Outcome Measures
NameTimeMethod
Degrees of Swaybaseline

The Sensory Organization Test is a six condition standard evaluation of balance control performed on a dynamic platform that can record sway movement in the A/P dimension while the sensory inputs from proprioception and vision are varied though the platform and visual surround movements. Condition 1 - eyes open, visual locked, platform locked. Condition 2 - eyes closed, visual locked, platform locked. Condition 3 - eyes open, visual unlocked, platform locked. Condition 4 - eyes open, visual locked, platform unlocked. Condition 5 - eyes closed, visual locked, platform unlocked. Condition 6 - eyes open, visual unlocked, platform unlocked. All participants progress though the exam, starting with condition 1 and ending with condition 6. All conditions were completed two to three times depending on performance with the average of each condition reported.

Secondary Outcome Measures
NameTimeMethod
Visual Analog Scales Scorebaseline

For the therapy portion of the study aim #2 Visual Analog Scales (VAS) related to the intensity of symptoms provoked by visual motion, head movements and walking in visually complex environments. The average Visual Analog Scale scores for the patient group pre and post therapy will be compared for any significant difference in the score (p\<0.05). The VAS ranges from 0-10, where 0 is no symptoms and 10 is the most intense symptoms experienced.

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

© Copyright 2025. All Rights Reserved by MedPath