Safety and Efficacy Study of BrainPort® Balance Device in Peripheral Vestibular Dysfunction.
Condition: Vestibular Diseases; Gait Disorders
MeSH terms: Vestibular Diseases
Study type: Interventional

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.
    

Detailed description: 
      Peripheral vestibular dysfunction can be caused by inner ear disorders, drug toxicity,
      neuritis, or a number of other causes. In the absence of a fully functional vestibular
      system, the brain often requires retraining to correctly utilize visual and proprioceptive
      cues to maintain postural stability. People with vestibular dysfunction experience multiple
      problems with posture control and movement, including an unsteady gait and various
      balance-related difficulties. These effects make it very difficult to walk in the dark or on
      uneven surfaces without risk of falling. They are typically referred for conventional
      vestibular therapy. Many patients improve with therapeutic intervention. Some patients reach
      a plateau and do not return to their previous level of function. The BrainPort balance device
      transmits head position information via electrotactile stimulation of the tongue. With
      training, patients learn to use the positional information to correct their balance.

      Participants meeting the study criteria will be randomized to the perceived stimulation or
      subliminal stimulation group. All participants will be given baseline assessments of postural
      stability, balance, and subjective well being according to standardized tests. After
      completing the baseline assessments, each participant will be trained in the clinic using a
      standard training protocol with the BrainPort balance device. Each participant will
      participate in 6 clinical training sessions, over a period of 3 consecutive days. Upon
      completion of the clinic training sessions, participants will continue with a 7½ week period
      of home use. During this period, the participant will train with the device for 20 minutes 2
      times per day and the clinicians will contact the participants weekly. At the end of the home
      training period (8 weeks from the beginning of the study), all participants will again
      undergo the tests given at baseline.

      Following the data analysis, subjects that have completed the 8 week study and were
      originally assigned to the group with inferior results will be given the opportunity to use
      the device that showed superior results in the data analysis.
    

Intervention name(s): Training with the BrainPort balance device
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): BrainPort Balance Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physical Therapy (Specialty); Balance dysfunction or disorder; Vestibular; Rehabilitation