<qa>  What is the name of the study group that will be used to determine eligibility for the study?A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment or sham placebo. A dedicated caregiver will apply the device to the subject for 20 minute daily sessions at home, 6 days a week for a total of 12 weeks. The subject and caregiver will be required to return to the clinic for follow-up assessments after 3, 6 and 12 weeks of treatment. 