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OpenTrials
Completed

NCT Number: NCT02048670

Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

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

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Key information

Conditions

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for 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.

Treatment and study plan

Balance Belt

Device

Vestibular habituation therapy worn under the clothes around the waist that uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and gait

Other names: Stabalon Belt, Vibrating Belt

Primary outcomes

  1. Degrees of Sway

    Time frame: baseline

    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 outcomes

  1. Visual Analog Scales Score

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Pilot Project to Investigate the Use of an External Vestibular Prosthesis Potential to Improve Clinical Management of Chronic Subjective Dizziness (CSD)

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 29, 2014
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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