This proposal outlines a program to test and clinically validate a new treatment to augment present therapy for cerebral palsy (CP), and to develop suitable therapeutic instrumentation for privately funded commercialization. Recently, one proposal author (Dr. Fields) introduced a revolutionary new technique for treating non-progressive brain damage, and has introduced the medical community to an appropriate treatment for stroke. Electronic Medical Instruments, Inc. (EMI) (the candidate grantee) has developed and is now marketing instrumentation providing practical administration for routine stroke therapy. Although the specific instrumentation requirements are likely to be quite distinct, the similarities between the movement disorders and habilitation requirements of stroke versus CP patients are often striking, especially for certain CP subtypes. In conjunction with a expert (Dr. Sells) on developmental disorders such as CP, the present Phase I proposal is directed to testing the (likely) feasibility of applying the Fields approach to this developmental problem of lifelong endurance. Given a Phase I demonstration of feasibility, the Phase II effort will provide a more extensive clinical validation of the approach and permit thorough CP device prototyping. Validation and prototyping will set the stage for Phase III commercialization of instrumentation suitable for widespread use in treating CP.
