Whole Body Hyperthermia Registry Study

The WBH procedure proposed in this protocol has been rigorously researched in subjects with
Major Depressive Disorder (MDD), and there are little to no preliminary data pertaining to
WBH use in populations outside of depression studies. In preliminary studies in Europe and a
rigorously tested clinical trial being conducted at the University of Arizona (NCT01625546),
a single exposure to WBH resulted in a decrease in depressive symptoms as measured using the
German version of the CES-D depression scale 5 days later (in the study in Switzerland) and
using the HamD rating scale 7 days later in the UA study. All research applications thus far
have resulted in minimal adverse effects to study subjects.

During the conduct of research protocol 12-0147-04/NCT01625546 (WBH in subjects with Major
Depression) our research site has been contacted by numerous individuals across the country
asking if they can participate in our clinical trial. However due to the rigorous
inclusion/exclusion criteria necessary for data collection, these individuals cannot be
offered the research treatment. This protocol is intended to become a secondary resort for
these individual's interested in receiving a Hyperthermia treatment for potential beneficial
gain related to symptoms stemming from other comorbidities (i.e. Fibromyalgia,
Perimenopausal symptoms, arthritis, etc). In fact, over the course of this study, several
individuals who suffer from fibromyalgia, rheumatoid arthritis and other similar afflictions
have, in discussions with study staff at screening, indicated that they have previously
researched infrared heating and whole body hyperthermia and found that it was helpful to
many people with these afflictions. As such, they are interested in being a part of the
study in order to receive treatment that might help ease their pain from these afflictions
in addition to the depression symptoms they are experiencing, given that depression is often
a co-morbidity of these illnesses. Due to the fact that no external research funding has
been acquired for this broad application, this protocol intended to charge a fee for cost
covering purposes only.

The registry trial will not be limited to only include individuals with MDD, however this
protocol will allow for an expanded use in all populations (while still excluding subjects
based on safety parameters). We will monitor subject's physiological and clinical outcomes
(if applicable) from a single Whole Body Hyperthermia treatment in an open fashion (no
placebo/control condition). This registry study will include safety assessments 5 days prior
to WBH, the day of WBH and 1 week following WBH.

Costs for Participating in the Study:

The WBH session is an investigational procedure, one approved for limited testing by the
Food and Drug Administration (FDA) but not in general use. In addition to your time, you
will be charged a fee of $800 for cost covering purposes only. The cost for this open
treatment hyperthermia session will cover departmental staff time, clinical space, research
materials, and overhead fees. You may pay with cash, check, or credit card. If you wish to
pay with a credit card, a 3% fee will be assessed to cover credit card processing fees. All
payments will be made to the Department of Psychiatry and will be processed by our
Departmental business office.

The payment may be broken into 2 tiers:

Screening: $200 WBH Procedure: $600 If you qualify for WBH procedure the remaining $600 will
be due prior to completion of the procedure.

If you pay in full and it is determined you do not qualify for the study, you will be
reimbursed less any amount needed to cover procedures performed (i.e. screening).

Future WBH Treatment Sessions:

If you wish to undergo another WBH procedure, you may do so without have to repeat screening
bloods and EKG's within 1 year of the original screen, so long as you report no significant
changes in your health history to the study staff. You will not be charged for screening
procedures for subsequent WBH procedures. Those individuals who have participated in
previous WBH protocols will be considered eligible without need for a re-screen within 1
year of their original screening procedures.

Inclusion Criteria:

- Male or female outpatients aged 18+.

- Able to understand the nature of the study and able to provide written informed
consent prior to conduct of any study procedures.

- Able to communicate in English or Spanish with study personnel.

Exclusion Criteria:

- If patient has a medical condition or disorder that:

- Is unstable and clinically significant, or:

- Could, in the investigator's opinion, interfere with the accurate assessment of
safety or efficacy of the procedure, including:

- Individuals who are using prescription drugs that may impair thermoregulatory
cooling,

- Individuals with cardiovascular conditions or problems (uncontrolled hypertension,
congestive heart failure, or documented evidence of coronary artery disease)

- Individuals with chronic conditions/diseases associated with a reduced ability
initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central
nervous system tumors, and diabetes with neuropathy,

- Individuals with a fever the day of study intervention (if so, they will be
rescheduled),

- Individuals with hypersensitivity to heat,

- Individuals with enclosed infections, be they dental, in joints, or in any other
tissues,

- Women who are pregnant Obesity and overall size of subject.

- It will be up to the PI's discretion will consider BMI, waist circumference, and body
fat composition when determining eligibility and safety of the individual.

- History of peripheral circulatory disease, for example peripheral vascular disease,
deep vein thrombosis (DVT), or lymphedema.

- History of stroke, epilepsy or cerebral aneurisms

- Diabetes mellitus types I or II.