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Dizziness Chronic | Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

Dizziness Chronic research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dizziness Chronic

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Balance BeltVestibular 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Vestibular Habituation Therapy3-5 repetitions for each of the sensitive head movements 3-5 repetitions for each of the sensitive visual motion Balance belt is not turned on

Study Status

Recruiting

Start Date: October 2014

Completed Date: July 2017

Phase: N/A

Type: Interventional

Design:

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

Secondary Outcome: Visual Analog Scales

Study sponsors, principal investigator, and references

Principal Investigator: Neil Shepard, PhD

Lead Sponsor: Mayo Clinic

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02048670

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