NCT00768378

Brief Summary

The purpose of this study is to assess the safety and efficacy of the BrainPort balance device in improving balance and gait as measured by clinically accepted standardized balance assessments in subjects with peripheral vestibular dysfunction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

1.7 years

First QC Date

October 6, 2008

Last Update Submit

June 27, 2012

Conditions

Vestibular DiseasesGait Disorders

Keywords

Physical Therapy (Specialty)Balance dysfunction or disorderVestibularRehabilitation

Outcome Measures

Primary Outcomes (1)

  • To assess the efficacy of the BrainPort balance device in improving balance and gait as measured by the Dynamic Gait Index (DGI) in subjects with documented peripheral vestibular dysfunction

    Baseline and 8 weeks (end of study)

Secondary Outcomes (3)

  • To assess the safety of electrical stimulation of the tongue during the use of the BrainPort balance device in subjects with documented peripheral vestibular dysfunction.

    Baseline and ongoing for the duration of the study (8 weeks).

  • To assess improvement in the Activities-specific Balance Confidence scale (ABC).

    Baseline and 8 weeks (end of study)

  • To assess improvement in the Dizziness Handicap Inventory (DHI).

    Baseline and 8 weeks (end of study)

Study Arms (2)

Perceived stimulation

EXPERIMENTAL

When subjects assigned to the perceived stimulation group increase the intensity of the stimulus, they will feel a tingling sensation on the tongue. The tingling will move on the tongue in relation to where the head/body moves.

Device: Training with the BrainPort balance device

Subliminal stimulation

EXPERIMENTAL

When subjects assigned to the subliminal stimulation group increase the intensity of the stimulus, the device provides a stimulus that is below their conscious awareness, so they will not be able to perceive it. The stimulus will move on the tongue in relation to where the head/body moves.

Device: Training with the BrainPort balance device

Interventions

Training with the BrainPort balance deviceDEVICE

Subjects are randomly assigned to one of two groups, the perceived stimulation group or the subliminal stimulation group. Some of these devices provide a stimulus that you can feel. Others provide a stimulus that is below conscious awareness. We are conducting this study to determine if one type of stimulation is more effective than the other.

Also known as: BrainPort Balance Device
Perceived stimulationSubliminal stimulation

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of peripheral vestibular dysfunction by the following (within 12 months of study enrollment):
  • Bilateral Vestibular Hypofunction (BVH)-Sinusoidal rotary chair results at least 2 SD below normal across the frequency range of 0.01 to 0.32 Hz, and at least 60 deg/s peak velocity.
  • Unilateral Vestibular Hypofunction (UVH)-Bithermal caloric test results of \> 25% unilateral weakness.
  • Minimum post 3 months diagnosis with residual balance problems.
  • Previously treated with conventional physical therapy, and discharged and/or reached a plateau.
  • Functional Ability:
  • Able to ambulate independently or with an assistive device for 20 feet.
  • Ability to stand independently for 2 minutes with no or minimal upper extremity support.
  • Dynamic Gait Index ≤ 19/24.
  • Able to read and sign the informed consent form.
  • Fluent in English.
  • Willing and able to complete all testing, training, and follow-up evaluations required by the study protocol.

You may not qualify if:

  • Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
  • Any medical condition that would interfere with performance on the assessments.
  • Known neuropathies of the tongue.
  • Prior exposure to BrainPort balance device.
  • History of seizures or epilepsy.
  • If female, pregnant. Subject must deny pregnancy and agree to use appropriate birth control to prevent pregnancy for the duration of the study.
  • People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator).
  • People currently taking any vestibular suppressant medication (i.e. barbiturates, benzodiazepines, betahistines or cortisone).
  • People with a previous diagnosis of a central nervous system lesion (e.g. stroke or brain injury).
  • Current diagnosis of any of the following:
  • Bilateral areflexia (no response to ice water caloric testing bilaterally)
  • Progressive neurological disease (such as Multiple Sclerosis)
  • Cervicogenic dizziness
  • Pre-syncope/syncope episodes
  • Orthostatic hypotension
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

England Physical Therapy

Los Angeles, California, 92840, United States

Location

South Valley Physical Therapy, PC

Centennial, Colorado, 80111, United States

Location

Sensory Therapeutics, Inc.

Jupiter, Florida, 33458, United States

Location

NBC Rehabilitation

North Miami Beach, Florida, 33160, United States

Location

Atlanta Ear Clinic

Atlanta, Georgia, 30342, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Elks Hearing & Balance Center

Boise, Idaho, 83702, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Missouri State University

Springfield, Missouri, 65897, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10010, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Houston ENT Clinic

Houston, Texas, 77024, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Pacific Balance and Rehabilitation Clinic

Seattle, Washington, 98109, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (6)

  • Danilov YP, Tyler ME, Skinner KL, Hogle RA, Bach-y-Rita P. Efficacy of electrotactile vestibular substitution in patients with peripheral and central vestibular loss. J Vestib Res. 2007;17(2-3):119-30.

    PMID: 18413905BACKGROUND

  • 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: 14643370BACKGROUND

  • 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: 15011268BACKGROUND

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

    PMID: 15988797BACKGROUND

  • Danilov YP, Tyler ME, Skinner KL, Bach-y-Rita P. Efficacy of electrotactile vestibular substitution in patients with bilateral vestibular and central balance loss. Conf Proc IEEE Eng Med Biol Soc. 2006;Suppl:6605-9. doi: 10.1109/IEMBS.2006.260899.

    PMID: 17959464BACKGROUND

  • Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.

    PMID: 16385646BACKGROUND

MeSH Terms

Conditions

Vestibular DiseasesMobility Limitation

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James O. Phillips, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 8, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

US(17)