Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Neil T. Shepard, Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02048670
First received: January 22, 2014
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention
Chronic Subjective Dizziness Syndrome
Device: Balance Belt

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Visual Analog Scales [ Time Frame: 1 year after the start of the therapy study portion ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vestibular Habituation Therapy
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.
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02048670

Contacts
Contact: Neil T Shepard, PhD 507 266 1965 shepard.neil@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Neil T. Shepard, Ph.D    507-266-1965    shepard.neil@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Neil Shepard, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Neil T. Shepard, Ph.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02048670     History of Changes
Other Study ID Numbers: 13-005525
Study First Received: January 22, 2014
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Pilot study
Assessment of sway phase
Therapy trial phase

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

ClinicalTrials.gov processed this record on July 20, 2014