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Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

Primary Purpose

Dizziness Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balance Belt
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dizziness Chronic focused on measuring Pilot study, Assessment of sway phase, Therapy trial phase

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chronic Subjective Dizziness Syndrome Subjects

Healthy Subjects

Arm Description

Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.

Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.

Outcomes

Primary Outcome Measures

Degrees of Sway
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 Outcome Measures

Visual Analog Scales Score
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.

Full Information

First Posted
January 22, 2014
Last Updated
April 24, 2019
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02048670
Brief Title
Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness
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 Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness Chronic
Keywords
Pilot study, Assessment of sway phase, Therapy trial phase

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic Subjective Dizziness Syndrome Subjects
Arm Type
Experimental
Arm Description
Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.
Arm Title
Healthy Subjects
Arm Type
Active Comparator
Arm Description
Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.
Intervention Type
Device
Intervention Name(s)
Balance Belt
Other Intervention Name(s)
Stabalon Belt, Vibrating Belt
Intervention Description
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
Primary Outcome Measure Information:
Title
Degrees of Sway
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Visual Analog Scales Score
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Staab, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

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