Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02048670
Recruitment Status : Unknown
Verified May 2016 by Neil T. Shepard, Ph.D., Mayo Clinic.
Recruitment status was:  Recruiting
First Posted : January 29, 2014
Last Update Posted : May 24, 2016
Information provided by (Responsible Party):
Neil T. Shepard, Ph.D., Mayo Clinic

Brief Summary:
This pilot study is focused on what assistance an external prosthetic device, the BalanceBeltTM can provide in the: 1) assessment and 2) treatment for patients with Chronic Subjective Dizziness (CSD). The BalanceBelt has sensitive detectors for movement in the anterior/posterior and medial/lateral planes and provides the person wearing the device vibro-tactile feedback as to the persons orientation with respect to gravity. The device is a full self contained device that is comfortably worn around the waist over a light weight shirt. The device is non-FDA approved and is in its final stages of beta testing. Patients with CSD do not have permanent vestibular deficits, but underutilize vestibular signals because they develop visual or somatosensory dependence. The investigators expect the BalanceBeltTM to reset this error by providing patients with reliable motion stimuli.

Condition or disease Intervention/treatment Phase
Dizziness Chronic Device: Balance Belt Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Project to Investigate the Use of an External Vestibular Prosthesis Potential to Improve Clinical Management of Chronic Subjective Dizziness (CSD)
Study Start Date : October 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vestibular Habituation Therapy
  1. 3-5 repetitions for each of the sensitive head movements
  2. 3-5 repetitions for each of the sensitive visual motion
  3. Balance belt is not turned on
Device: Balance Belt
Vestibular habituation therapy for sensitivity to visual motion, visual complex environments, head movements and visual patterns. The exercises will have 3-5 repetitions for each of the head movement or visual stimuli that cause and increase in the symptoms of unsteadiness or self motion. These exercises will be done while wearing the Balance Belt for feedback information as to how much the patient is swaying.
Other Names:
  • Stabalon Belt
  • Vibrating Belt

Primary Outcome Measures :
  1. Significant difference (p<0.05) in sway magnitude fore and aft / right left between CSD patients and the age and gender matched controls [ Time Frame: 8 months after the start of the assessment study protion ]
    The measures of sway will be recorded on the BalanceBelt without feedback to the subjects. These measures of sway will represent the average sway of the patient (CSD) group and the control group.

Secondary Outcome Measures :
  1. Visual Analog Scales [ Time Frame: 1 year after the start of the therapy study portion ]
    For the therapy portion of the study aim #2 Visual Analog Scales related to the intensity of symptoms provoked by visual motion, head movements and walking in visually complex environments. These same measures will be taken at the begining and end of the one week of intensive therapy. 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).

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02048670

Contact: Neil T Shepard, PhD 507 538 0090

United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Neil T. Shepard, Ph.D    507-266-1965   
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Neil Shepard, PhD Mayo Clinic

Responsible Party: Neil T. Shepard, Ph.D., PI, Mayo Clinic Identifier: NCT02048670     History of Changes
Other Study ID Numbers: 13-005525
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by Neil T. Shepard, Ph.D., Mayo Clinic:
Pilot study
Assessment of sway phase
Therapy trial phase

Additional relevant MeSH terms:
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases