Wicab, Inc. has developed the BrainPort™ technology to transmit external sensory information to the brain through a substitute sensory channel: electrotactile stimulation of the tongue. The use of the tongue as a sensory substitution channel has been previously established (see technical papers section of web site). For the brain to correctly interpret information from a sensory substitution device, it is not necessary for the information to be presented in the same form as the natural sensory system. For example, we do not see with the eyes; the optical image does not go beyond the retina where it is turned into spatio-temporal patterns of action potentials along the optic nerve fibers. The brain then recreates the images from analysis of the impulse patterns. Thus, for a sensory substitution event to occur, one need only to accurately entrain action potentials in an alternate information channel, which do not differ significantly for the individual senses. With training, the brain learns to appropriately interpret that information and utilize it to function as it would with data from the intact natural sense. In the proposed balance applications, the BrainPort device substitutes for the lack of vestibular input by transmitting information about head position, as sensed by an accelerometer, to an electrode array placed on the tongue. Prior research with a prototype device has shown that the BrainPort device permits people with severe or profound Bilateral Vestibular Loss (BVL) to maintain near-normal static posture control under a variety of conditions, including quiet sitting or standing and during activities of daily living, such as walking in a crowd or on soft uneven surfaces.* The BrainPort balance device is essentially a mechanism to supply sensory information to the subject through electrical impulses directed to the tongue. The tongue is a uniquely qualified target for electrical impulses because of 1) the density and sensitivity of nerve fibers at this site and 2) the suitability of the tongue to receive and maintain electrical contacts in terms of chemical environment, which minimizes the electrical energy requirement and point of contact skin irritation.They sponsor clinical trials.. I am fitted for all the criteria except for one..
Wicab is sponsoring clinical trials at various medical centers in the U.S. and Europe to evaluate the effectiveness of the BrainPort® balance device as a treatment for patients with balance difficulties. Subjects enrolled in the current stroke study must meet all of the following criteria:
- Male or female, at least 18 years old.
- Documented history of stroke for a duration of at least 3 months which has been treated with conventional therapy. Have reached a plateau and been discharged from physical therapy. Able to ambulate with assistance.
- Berg balance scale score of <46>46>
- 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.
Standard Procedures for Clinical Trials:
- Prior to beginning a clinical trial, the study is carefully reviewed and approved within each clinical site by an Institutional Review Board, which includes doctors, administrators, ethicists and members of the general public.
- All volunteers for clinical trials must meet the trial inclusion and exclusion criteria and sign a consent form that will describe the purpose of the trial, its duration, the procedures used, benefits and risks of the study. Volunteers may leave a clinical trial at any time without penalty.
- Subject and patient confidentiality is fully protected. Patient identifying information and data collected will not be accessible outside of the clinical site without written permission by the volunteer.
No comments:
Post a Comment