A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome

Few clinical trials have looked into non-pharmacological, non-invasive treatments for
restless legs syndrome, despite reports that massage, baths and vibrations can alleviate RLS
symptoms. We would like to assess whether the MMF007 Foot Massager device and/or heat therapy
is associated with improved severity of RLS symptoms.

For this study the investigator will enroll 40 participants who have been diagnosed with
restless legs syndrome, who will be followed over the course of four weeks and asked to
complete two in person study visits. In the study the investigator is comparing the use of
the MMF007 Foot Massager device and/ or heat therapy to a non treatment group to assess if
the symptoms of RLS improve.

Inclusion Criteria:

1. Subjects between 18-75 years old diagnosed with RLS according to the diagnostic
criteria of the International Restless Legs Syndrome Study Group (11)

2. Subjects should have bothersome RLS symptoms, despite best medical therapy

3. Subjects should be stable on all RLS medication for at least 4 weeks prior to
enrollment

4. All subjects must have vision and be proficient in English for compliance with testing
and surveys

5. All women of childbearing age must be using an acceptable form of birth control,
including abstinence, intrauterine device (IUD) or intrauterine system in place for at
least 3 months prior to screening, subject or partner using barrier method (e.g.,
condom, diaphragm, or cervical cap) with spermicide from screening through study
completion; partner has a documented vasectomy > 6 months prior to Baseline, Stable
hormonal contraception (with approved oral, transdermal, or depot regimen) for at
least 3 months prior to screening

Exclusion Criteria:

1. RLS secondary associated with end stage renal disease, iron deficiency or pregnancy

2. Concomitant sleep disorders

3. Any other condition (other than the primary indications), which in the opinion of the
investigators might contribute to difficulty complying with the protocol