Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke

Cerebrovascular Accident Clinical Trial

Official title:

A Substitute Vestibular Information System Using the BrainPort® Balance Device for Adults With Chronic Vestibular Dysfunction Following Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567944
• Other study ID #: WCB4-001
• Status: Completed
• Phase: N/A
• First received: December 3, 2007
• Last updated: June 27, 2012
• Start date: June 2007
• Est. completion date: April 2010

Study information

• Verified date: June 2012
• Source: Wicab
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of the BrainPort balance device in improving balance in people with balance deficits due to stroke.

Description:

Following baseline assessments, subjects participate in 5 consecutive days (10 hours) of clinic training with the BrainPort balance device with a Physical Therapist. Assessments are repeated at the end of clinic training. Following clinic training, subjects take the device home to use for two (2) 20 minute training sessions each day. Subjects return to the clinic for one (1) day of testing after using the device at home for 7 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years old.

• Diagnosis of stroke for at least 6 months.

• Reached a plateau and been discharged from physical therapy.

• Able to ambulate with or without assistance.

• Ongoing balance problem.

• Able to read and understand the informed consent form, and willing to sign the informed consent form.

Exclusion Criteria:

• 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.

• History of seizures.

• Pregnancy.

• Cognitive deficits (Mini-Mental 25 or below), joint replacements, cervical vertigo, or major neurologic disease, major depression or disabling psychiatric disorder.

• Known neuropathies of tongue or skin tactile system.

• Prior exposure to BrainPort® balance device.

• 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 nerve, lingual nerve, or hypoglossal nerve.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Device:
• BrainPort Balance Device
The BrainPort balance device, is a non-invasive medical device that provides head and body position information to a person via their tongue.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Middleton	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Wicab

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. Review. — View Citation

Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Gait Index		baseline, 5 days, end of study	No
Primary	Berg Balance Scale		Baseline, 5 days, end of study	No
Primary	Activities-specific Balance Confidence Scale		Baseline, 5 days, end of study	No
Primary	Timed Up and Go		Baseline, 5 days, end of study	No
Primary	Stroke Impact Scale		Baseline, 5 day, end of study	No

External Links

•   Wicab Inc. homepage