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

NCT00254228 | Terminated

• 1 other identifier: WCB1-001
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Vestibular Disease

Keywords

Balance; Vestibular; Electrotactile; BrainPort; Sensory substitution; Tongue

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• 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.

Interventions

Electrotactile sensory substitution DEVICE

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wicab: lead

Study Sites (5)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Wisconsin, Madison

Madison, Wisconsin, 53792, United States

Location

Medway Balance Centre

Kent, ME7 5NY, United Kingdom

Location

Related Publications (4)

• Bach-y-Rita P, W Kercel S. Sensory substitution and the human-machine interface. Trends Cogn Sci. 2003 Dec;7(12):541-6. doi: 10.1016/j.tics.2003.10.013.

  PMID: 14643370 BACKGROUND

• Tyler M, Danilov Y, Bach-Y-Rita P. Closing an open-loop control system: vestibular substitution through the tongue. J Integr Neurosci. 2003 Dec;2(2):159-64. doi: 10.1142/s0219635203000263.

  PMID: 15011268 BACKGROUND

• Bach-y-rita P, Danilov YP, Tyler ME, Grimm RF. Late Human Brain Plasticity: Vestibular Substitution with a Tongue BrainPort Human-Machine Interface. Journal Intellectica, 2005 (in press).

  BACKGROUND

• Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.

  PMID: 15988797 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Yuri P Danilov, PhD

  Wicab

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 15, 2005
• Study Start: November 1, 2005
• Study Completion: December 1, 2007
• Last Updated: October 9, 2008

Record last verified: 2008-10

Locations

US (4); GB (1)