 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. 