Safety and Efficacy of the BrainPort™ Balance Device to Improve Balance in Bilateral Vestibular Hypofunction

This study has been terminated.
(Terminated due to slow recruitment)
Sponsor:
Information provided by:
Wicab
ClinicalTrials.gov Identifier:
NCT00254228
First received: November 10, 2005
Last updated: October 8, 2008
Last verified: October 2008
  Purpose

The purpose of this study is to determine whether the BrainPort™ balance device is safe and effective in the treatment of balance disorders in patients with Bilateral Vestibular Dysfunction.


Condition Intervention
Vestibular Disease
Device: Electrotactile sensory substitution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Clinical Study to Evaluate the Safety and Efficacy of the BrainPort™ Balance Device When Used to Improve Postural Control in Subjects With Bilateral Vestibular Disorders

Resource links provided by NLM:


Further study details as provided by Wicab:

Primary Outcome Measures:
  • Computerized Dynamic Posturography using the NeuroCom Sensory Organization Test (SOT) composite score, taken at baseline, 1 week, 8 weeks and 12 months.

Secondary Outcome Measures:
  • Activities-specific Balance Confidence Scale (ABC)
  • Dizziness Handicap Inventory (DHI)
  • Dynamic Gait Index (DGI)
  • Number of falls on the NeuroCom SOT
  • Functional Objective Tests i.e. standing with eyes closed, on one leg, etc.
  • All tests taken at baseline, 1 week, 8 weeks and 12 months.

Estimated Enrollment: 60
Study Start Date: November 2005
Estimated Study Completion Date: December 2007
Detailed Description:

People with Bilateral Vestibular Dysfunction (BVD) often experience disabling symptoms, greatly affecting their quality of life and ability to work. Current vestibular treatment does not always allow these patients to fully recover. Many patients either do not improve or reach a plateau with conventional vestibular rehabilitation, and still have difficulty with daily function. The BrainPort™ balance device is intended to provide information about head position to the brain through electrotactile stimulation of the tongue to improve balance in subjects with vestibular disorders.

This study is a prospective, multi-center, randomized double-blinded study comparing the postural stability of BVD subjects using the BrainPort™ balance device to postural stability of control subjects using a sham device and respective baseline measures for each group. The primary objective of this study is to determine whether electrotactile stimulation of the tongue, using the BrainPort™ balance device, can improve postural stability, as measured by improvement in performance of the composite Computerized Dynamic Posturography using the NeuroCom® Sensory Organization Test in subjects with chronic bilateral vestibular dysfunction (BVD). The secondary objectives are to evaluate improvement in quality of life, as measured by the Activities Specific Balance Confidence (ABC) Scale, Dizziness Handicap Inventory (DHI), and the Dynamic Gait Index (DGI), and to demonstrate a decreased number of falls on the NeuroCom® Sensory Organization Test. In addition, we will monitor the number of falls that occur during subjects' normal activities of daily living. The long-term objective is to evaluate the safety and efficacy when the device is used over a one-year period.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented history of acquired bilateral vestibular dysfunction for a duration of at least one year which has been unsuccessfully treated or reached a plateau with conventional vestibular rehabilitation.
  • No greater than 2 successful attempts out of 6 on the NeuroCom Equitest Sensory Organization Tests 5 and 6.
  • Failure on the Rotary Chair Vestibulo-ocular Reflex (VOR) Test as evidenced by a gain of less than or equal to -2 standard deviations at frequencies of .025, and .05 Hz.
  • Normal corrected vision (20/40 or better).
  • Able to read and understand the informed consent form, and willing to sign the informed consent form.
  • Willing to complete all follow-up evaluations required by the study protocol.
  • Able to stand for a period of 20 minutes in a stationary position with weight evenly distributed without moderate pain, muscle cramping or numbness in the lower extremities.

Exclusion Criteria:

  • Neurological disorders other than bilateral vestibular disorder, as determined by medical history and neurological screening procedure.
  • Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
  • Cigarette smokers and those who use chewing tobacco.
  • Currently taking either benzodiazepine or barbiturate medication.
  • Any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests.
  • Known neuropathies of tongue or skin tactile system.
  • Peripheral neuropathies of the lower extremities.
  • Prior exposure to BrainPort™ balance device (does not apply to control group subjects who cross over).
  • Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.
  • Subjects who have undergone middle ear or other surgery with sacrifice or damage to the chorda tympani, lingual, or hypoglossal nerve.
  • Subjects who have an implanted device such as a pacemaker or defibrillator.
  • If the subject is female, she is pregnant.
  • If the subject is unwilling to discontinue medications for dizziness or imbalance 48 hours prior to beginning the study.
  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: NCT00254228

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53792
United Kingdom
Medway Balance Centre
Kent, United Kingdom, ME7 5NY
Sponsors and Collaborators
Wicab
Investigators
Study Director: Yuri P Danilov, PhD Wicab
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00254228     History of Changes
Other Study ID Numbers: WCB1-001
Study First Received: November 10, 2005
Last Updated: October 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Wicab:
Balance
Vestibular
Electrotactile
BrainPort
Sensory substitution
Tongue

Additional relevant MeSH terms:
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014