Clinical Trial: Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

Purpose:

Hypothesis: #1The use of the BalanceBelt™ will provide differential information about body sway movements during specific clinical balance and gait tasks in patients with CSD that is not currently available through routine measures.

Hypothesis: #2 The use of the BalanceBelt™ will provide for a more rapid rate of reduction in patient symptoms compared to the historical data from the traditional habituation therapy method.

Aims, purpose, or objectives: #1 Motion detectors contained in the BalanceBeltTM will be used to record information about the subtle changes in posture and gait that are thought to occur in patients with CSD with the tactors turned off. The goal of this portion of the study will be to improve diagnostic strategies for CSD.

Aims, purpose, or objectives: #2 In this second portion of the study the investigators will test the benefits of a one week intensive rehabilitation program using the BalanceBeltTM with tactors activated in 10 patients with CSD. The goal of this study will be to develop a treatment that is quicker and more effective than current therapies.

Background:

Chronic subjective dizziness (CSD) is the second most common condition identified in patients referred to Mayo Clinic for persistent dizziness. The investigators manage nearly 500 patients with CSD each year. CSD is a syndrome of persistent non-vertiginous dizziness and unsteadiness that may be worsened by patients' own motion, exposure challenging visual stimuli such as busy shopping areas, or performance of precision visual tasks such as reading. CSD develops in about 25% of patients following medical events that acutely
Sponsor: Mayo Clinic

Current Primary Outcome: 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.


Original Primary Outcome:

  • 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.
  • 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).


Current Secondary Outcome: 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).


Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: January 22, 2014
Date Started: October 2014
Date Completion: July 2017
Last Updated: May 23, 2016
Last Verified: May 2016