Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

NCT02048670 | Completed Results

• 1 other identifier: 13-005525
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dizziness Chronic

Keywords

Pilot study; Assessment of sway phase; Therapy trial phase

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline

Secondary Outcomes (1)

• Visual Analog Scales Score

  baseline

Study Arms (2)

Chronic Subjective Dizziness Syndrome Subjects

EXPERIMENTAL

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

Device: Balance Belt

Healthy Subjects

ACTIVE COMPARATOR

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

Device: Balance Belt

Interventions

Balance Belt DEVICE

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

Also known as: Stabalon Belt, Vibrating Belt

Chronic Subjective Dizziness Syndrome Subjects; Healthy Subjects

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Dr. Devin L. McCaslin
• Organization: Mayo Clinic

mccaslin.devin@mayo.edu

507-284-3410

Study Officials

• Jeffrey Staab, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 29, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 15, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)