IRB Migraine Project

SIGNATURE PAGE

(Attach to each copy of your proposal)

 

Fill in all the blanks.

 

 

Does the subject group include healthy volunteers? _x_Yes __No

Does the subject group include ill persons?        __Yes _x_No

Are subject groups excluded for medical reasons? _x_Yes __No

Are there vulnerable subject groups? __Yes _x_No

If yes, is the exclusion criteria for the study specified? __Yes __No  _x_NA

Are any subjects under the age of 18? __Yes _x_No

Are any subjects under the age of 12? __Yes _x_No

Are any subjects over the age of 70? __Yes _x_No

 

 

Yasmen Simonian                                                                               September 30, 2005   Clinical Laboratory Sciences

Principal Investigator’s Name   Principal Investigator’s Signature                Date                      Department

 

 

ysimonian@weber.edu,              3905 University Circle, Ogden, Utah 84408-3905               801.626.7080

Principal Investigator’s email address       Mailing Address/Mail Code/City, State, Zip            Telephone

 

 

Marc Schmitt and Rhett Crapo                                                                   Clinical Laboratory Sciences

Student Researcher’s Names                                                                             Department

 

 

Yasmen Simonian                                                                             September 30, 2005        801.626.7080

Department Chair’s Name       Department Chair’s Signature                               Date                                 Telephone

 

 

 

A.                                                        APPLICATION FORM

 

The application form must be filled out completely so committee members may have a clear understanding of the nature and human subject implications of the research proposal.  A summary paragraph fir each section is sufficient.  A statement referring to the attached materials is not sufficient and will not be accepted.  Applications submitted with incomplete forms will be returned without consideration of the proposal.

 

 

1. TITLE

The relationship of sex hormones and migraine headaches in men.

 

2. DESCRIPTION OF THE STUDY

The effect of fluctuating testosterone and estradiol levels on migraine headaches in men will be assessed. A correlation has been found in menstruating women between fluctuations in sex hormone levels and onset of migraine. Volunteer participants will be asked to complete a survey to assess their health status, current medication usage, and migraine classification.  Phlebotomists will be available at Davis Hospital’s laboratory to collect one migraine-based and three baseline venipuncture samples from each participant.

 

3. DURATION OF THE STUDY

The forming of an appropriate sample group will commence upon receipt of funding. After collection of migraine-based samples, the research participants will be given a thirty day period in which they must return to the laboratory to have the remaining three baseline samples collected.  All data collection will be completed by February 15th, 2006.  Data analysis and interpretation, including a final project report, will be completed by April 2006.             

                                                                                                           

4. MULTICENTER STUDY

This study will be completed by Weber State University’s Clinical Laboratory Sciences program in conjunction with Davis Hospital and Medical Center.

 

5. NUMBER OF SUBJECTS

The total number of male subjects needed for this study is at least 20. All subjects will be tested at Davis Hospital laboratory.

 

6. HEALTH STATUS OF THE SUBJECTS

The subjects will be chronic male migraine sufferers. They will be normal, healthy individuals aside from classic or common migraines.

 

7. SUBJECT GROUPS EXCLUDED

Test subjects undergoing hormonal treatments will not be included. All subjects not diagnosed by a licensed physician as having common or classic migraines will be excluded. In addition, any subjects with medical conditions involving abnormal levels of sex hormones will be excluded.

 

8. AGES OF THE SUBJECTS

Subjects will be 20-55 years old.

 

9. DESIGN OF THE STUDY

From one group of twenty volunteer subjects, one migraine-based and three baseline samples will be collected. The mean of the baseline samples will be determined. A paired t-test with an alpha level of 0.05 will be used to compare the two levels (migraine based vs. mean baseline). Regression analysis will then be performed and a correlation coefficient will be determined to assess whether there is a significant difference between baseline and migraine based concentrations.

 

10. RISKS TO SUBJECTS

Blood samples will be obtained by professional phlebotomists at Davis Hospital. All participants will be closely monitored for adverse reactions that may occur due to blood draws. The risks of normal blood draw are very minimal. An individual may experience bruising or slight bleeding due to the draw. In addition, an individual may experience dizziness, faint feeling, or possible loss of consciousness. If such a reaction were to occur, the phlebotomists are trained to handle such circumstances. The blood draw will be discontinued if such reactions occur.

 

ANY MODERATE OR HIGH RISK STUDY MUST GO THROUGH A SEPARATE REVIEW PROCEDURE WHICH INCLUDES THE APPROPRIATE ADMINISTRATIVE OFFICER AND THE UNIVERSITY ATTORNEY.

 

11. BENEFITS TO SUBJECTS AND OTHERS

Subjects will be compensated thirty dollars for time and travel upon completion of the final baseline sample. Those who do not complete the study due to withdrawal or other reasons will be replaced by another suitable test subject. No compensation will be given to those test subjects who do not complete the study.

 

12. COSTS TO BE BORNE BY SUBJECTS

Subjects will be required to provide transportation to and from the hospital. Thirty dollars per participant will be given to reimburse this travel.

 

13.  IS CONFIDENTIALITY ASSURED

Subjects will be procured through placement of fliers in local hospitals, clinics, and on the WSU campus.  A copy of this flier is included at the end this application.  Those responding to the flier will have the opportunity to attend an informational meeting at which a packet, including a basic health survey and participant consent form, will be distributed. Copies of these documents are attached at the end of this application.  Adequate time to read the Experimental Subject’s Bill of Rights and to read and sign the consent form will be given.  Each packet will be identified by a unique number.  This number will be the exclusive method of participant and sample identification throughout the study.  These numbers will be used to label the blood samples drawn from the participants at Davis Hospital’s laboratory, a WSU CLS affiliate in Layton, Utah.  Mr. Jim McBride, Davis Hospital’s laboratory director and an adjunct CLS faculty will supervise the collection process.  As a double blind study, participant’s names and histories will not be divulged to the researchers in conjunction with their test results. 

 

 

14. CONTRACT OR GRANT NUMBER

A proposal for continuation of this project will be submitted to WSU Undergraduate Research Committee and to the Dumke College of Health Professions Marriott Research Committee.

 

15.  NAME OF PRINCIPAL INVESTIGATOR AND DEPARTMENT

Dr. Yasmen Simonian, Chair of the Clinical Laboratory Sciences department is the principle investigator of the study.  The senior students assisting with this study are Marc Schmitt and Rhett Crapo.                                                                   

 

B.                                            DESCRIPTION OF THE STUDY

 

1.  BACKGROUND INFORMATION

Many studies have implied a strong correlation between estradiol levels and migraine headaches.  Pioneering menstrual migraine studies, in 1972, an Australian research group found a link between migraine onset and rapid decline of blood estradiol levels.  Estradiol is the most potent and prevalent circulating hormone of the estrogen family.  Since this landmark study, many epidemiological and clinical studies have been completed, supporting and expanding this theory.  Clinical evidence shows that more than 50% of women with migraine report an association between migraine and menstruation.  Hormone-related migraines typically occur during a perimenstrual, five day window. This window begins two days before menses and ends three days after menses initiates, when estradiol concentrations drop significantly. This evidence has led to the use of prophylactic hormonal treatments for female migraine sufferers with notable success.

 

While much research has focused on the role of estradiol in migraines affecting reproductive-age women, little attention has been given to the possible role of sex hormones influencing migraines in men. As testosterone is a biologically similar hormone to estradiol and testosterone is converted to estradiol in vivo, the possibility exists that fluctuating testosterone levels could influence the onset of migraines in males.  Plasma testosterone concentrations fluctuate due to its pulsatile secretion and diurnal rhythm, usually peaking at about 8 AM and falling to low levels at about 8 PM.  Although sexual hormone fluctuations occur to a lesser degree in males than females, the presence of this change in concentration warrants further study.  This may correspond to the decreased incidence of migraines in men versus women.  Decreased production of testosterone has been seen in men over 55 years of age, individuals under significant amounts of stress, and as a result of illness. Any rapid change in circulating testosterone or estradiol could contribute to the incidence of migraines in men. This study will collect blood samples from a population of men to determine if rapid changes in circulating testosterone or estradiol levels contribute to the onset of migraines in men.  

 

2.  EXPERIMENTAL METHODS

This project will be performed in conjunction with Davis Hospital’s laboratory, in Layton, Utah.  Jim McBride, Davis Hospital’s laboratory director and WSU affiliate has offered the laboratory for use in this study.  As a pilot study, the relationship between testosterone and estradiol fluctuations and migraines will be studied in a sample of 20 males, ages 20-55 years, with history of chronic migraine.  The test subjects involved will include individuals that have been clinically diagnosed with either classic or common migraine who reside in Davis or Weber counties.  A written survey will then be administered to determine the most appropriate subjects for the study.  As a double blind study, participant’s names and histories will not be divulged to the researchers in conjunction with their test results. 

 

As it is not offered at Davis Hospital laboratory, an ultra-sensitive serum estradiol assay will be performed by Quest Diagnostics reference laboratory. This test includes reference ranges for males of all ages. The total testosterone serum-based assay will be performed at Davis Hospital laboratory on the Beckman-Coulter Access analyzer.  Phlebotomists will be available at Davis Hospital’s laboratory to collect one migraine-based and three baseline samples from each participant.  The first sample will be collected while the participant is experiencing a migraine.  Once migraine symptoms subside, three baseline samples will be collected during three scheduled time-blocks.  As sex hormone levels vary diurnally, a morning (6-9 am), afternoon (12:30-3:30 pm), and evening (7-10 pm) baseline sample will be obtained. This will give a general daily trend of hormone production for each participant.  Sex hormone concentrations collected during migraine will then be contrasted to normal daily fluctuations.  Upon completion of the laboratory testing procedures, the blood samples will be labeled as biohazards and will be discarded with other routine laboratory samples at Davis Hospital Clinical Laboratories.

 

3.  DESCRIPTION OF RECRUITMENT PROCEDURES

Subjects will be procured through placement of informational fliers in local hospitals, clinics, and the WSU campus.  A copy of this flier is included at the end this application.

 

4.  MODERATE OR HIGH RISK

There should be very low risk to participants, since they will only have their blood samples drawn.

 

 


C.                                                        INFORMED CONSENT

 

TITLE:  The relationship of sex hormones and migraine headaches in men

 

INVESTIGATOR:

Dr. Yasmen Simonian (801.626.7080), Rhett Crapo, Marc Schmitt

Clinical Laboratory Sciences Department

Weber State University

3905 University Circle

Ogden, Utah 84408-1208

 

If there are any other inquiries regarding the process or concerns not directly related to the study, the participants may direct them to the Institutional Review Board (IRB). The following is the name and the contact information for such questions:

Dr. Marjukka Ollilainen, (801.626.6238)

Chair of the IRB committee

Weber State University

1208 University Circle

Ogden, UT 84408-1208

 

PURPOSE OF STUDY:

To determine if fluctuating sex hormone levels contribute to migraine onset in males.

 

STUDY PROCEDURE RISKS:

There are no serious risks involved in participating in this research study.  As with all blood collection, minor bruising or bleeding near the collection site may occur.  There may be a possible risk of dizziness, lightheadedness, or loss of consciousness during or after blood collection.  If such a reaction were to occur, the phlebotomists are trained to handle such circumstances. The blood draw will be discontinued if such reactions occur.  Also, as personal transportation to the collection site is required, normal risks of driving are assumed.

 

BENEFITS:     

Hormonal treatments have had significant success in women with migraines affected by shifts in sex hormone levels.  Finding a similar relationship in males may broaden the scope of treatment possibilities, and promote new avenues of migraine research. 

 

Participants will be compensated thirty dollars for time and travel upon completion of the final baseline sample. Those who do not complete the study due to withdrawal or other reasons will be replaced by another suitable test subject. No compensation will be given to those test subjects who do not complete the study.

 

CONFIDENTIALITY:

You have a right to privacy.  All information that is obtained in connection with this study that can be identified to you will remain confidential.  For collection and analysis purposes, you and your sample will be referenced by the number on this packet only.  Each blood sample will be disposed of immediately following testing with other routine laboratory samples at Davis Hospital Clinical Laboratories. The results of this study may be used in presentations, scientific publications, or further research; however, no participant will be identified by name.

 

VOLUNTARY PARTICIPATION:

Your decision to participate in this study is completely voluntary and you are free to refuse to participate in this study at any time.

 

TRANSPORTATION AGREEMENT:

All blood collection will take place at Davis Hospital’s laboratory.  Transportation to and from the hospital must be provided by the participant.  As the initial sample will be collected while the participant is experiencing migraine symptoms, driving oneself under these conditions could prove hazardous.  By participating in this study, you agree to arrange for another, licensed driver (including public transportation) to transport you to the hospital to provide the migraine-based sample.  For the following three baseline samples, the participant is permitted to drive oneself if so desired.

 

CONSENT:

In signing this consent form, I have given permission for the investigators to use any results obtained during the test process with the understanding that all efforts will be made to keep my identity confidential.  My signature indicates that I have read the above information and I have had the opportunity to ask any questions regarding this study or my participation therein.  I agree to participate in this study.  I also acknowledge having received a copy of this agreement.  I understand that by signing this form, I have not waived any of the legal rights to which I otherwise would have as a participant in a research study.

 

 

 

Name of Participant (Print)

 

 

 

Participant’s Signature                                                              Date

 

 

 

 

  

D.                                EXPERIMENTAL SUBJECT’S BILL OF RIGHTS

 

The rights below are the rights of every person who is asked to be in a research study.

 

As an experimental subject, I have the following rights:

 

            1.  To be told what the study is trying to find out.

 

2.  To be told what will happen to me and whether any of the procedures, drugs, or devices are different form what would be used in standard practice.

 

3.  To be told about the frequent and/or important risks, side effects or discomforts of the things that will happen to be me for research purposes.

 

4.  To be told if I can expect any benefit from participating and, if so, what that benefit might be.

 

5.  To be told what other choices I might have and how they may be better or worse that being in the study.

 

6.  To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study.

 

7.  To be told what sort of medical treatment is available if any complications arise.

 

8.  To refuse to participate at all or to change my mind about participating after the study is started.

 

            9.  To receive a copy of the signed and dated consent form.

 

10.  To be free of any pressure when considering whether I wish to agree to be in the study.

 

                                                                      


PARTICIPANT MIGRAINE HISTORY AND HEALTH INFORMATION

 

 

 

Gender:  male  /  female        Age:  ______                       Height:  _______ Weight:  _______

 

Have you been diagnosed with migraine by a licensed physician?                            YES  /  NO

 

Does any member of you immediate family suffer from migraines?                             YES  /  NO

 

                If YES, what is their relation to you?  ________________

 

How old were you when you first experienced migraine symptoms?  ___________

 

Check all of the following symptoms you experience (if any) before the onset of migraine headache:

?                        Visual disturbances

?Seeing flashing lights

?Seeing zig-zags

?Seeing variation in color

?Vision loss

?Numbness or tingling on one side of the face

?Pain around the eye

?Abdominal discomfort

?Nausea

 

 

If you experience any of the above symptoms, how long before the onset of headache do they

 

occur?  ________________________________

 

Are you currently taking any medications?    YES  /  NO

 

                If YES, list them:_________________________________________________________

 

Have you been diagnosed with a disease related to the production of sex hormones?   YES  /  NO

 

Aside from experiencing migraines, do you feel you are an otherwise healthy

individual?            YES  /  NO

 

                If NO, explain___________________________________________________________

 

                _______________________________________________________________________

 

Check the items that seem to trigger your migraines:

 

Dietary Factors:

 

?Alcoholic beverages

?Aged cheese

?Chianti wine

?Pickled herring

?Dried smoked fish

?Sour cream

?Yogurt

?Yeast extracts

?Chocolate

?Citrus fruits

?Dairy products

?Onions

?Nuts

?Beans

?Caffeine (excess, withdrawal)

?Aspartame artificial sweetener (NutraSweet, Equal)

?Nitrites (e.g., hot dogs, lunch meat)

?Monosodium glutamate (MSG)


Environmental Factors:

?Bright lights

?Flickering light sources

?Fluorescent lighting

?Perfumes

?Strong odors

?Fumes from industrial complexes

?Air pollution

?Second-hand cigarette smoke

?Motion

?Travel

?Complex visual patterns (e.g., checks, zig-zag line)

?Weather changes

 

Lifestyle Factors:

?Stress

?Disrupted sleep patterns

?“letdown”

?Fatigue

?Irregular eating habits

?Cigarette smoking

 

 

 

 

 

Medications:

?Blood vessel dilating drugs (e.g., nitroglycerin)

?Drugs for high blood pressure (e.g., hydralazine, reserpine)

?Diuretics

?Anti-asthma medications (e.g., aminophylline)

?Too-frequent use of analgesics, ergotamine

 

Physical Factors:

?Head trauma

?Invasive medical tests (adverse effect)

?Exertion (e.g., sports, sexual orgasm)

?Disorders of the neck

 

Hormonal Factors:

?Onset of puberty


 

 

 

 

Migraine Meeting

 

Who:         Males; ages 20-55 years old

Where:  Weber State University

               Marriot Health Building

               Room # (To Be Determined)

 

When:    (To Be Determined)

 

Participants selected for this study will be

compensated $30.00 upon completion.

 

If you have any questions regarding this study, please contact:

Dr. Yasmen Simonian at 626-6118 or ysimonian@weber.edu

 

 

Migraine Meeting

 

Who:         Males; ages 20-55 years old

Where:  Weber State University

               Marriot Health Building

               Room # (To Be Determined)

 

When:    (To Be Determined)

 

Participants selected for this study will be

compensated $30.00 upon completion.

 

If you have any questions regarding this study, please contact:

Dr. Yasmen Simonian at 626-6118 or ysimonian@weber.edu

 

 

Migraine Meeting

 

Who:         Males; ages 20-55 years old

Where:  Weber State University

               Marriot Health Building

               Room # (To Be Determined)

 

When:    (To Be Determined)

 

Participants selected for this study will be

compensated $30.00 upon completion.

 

If you have any questions regarding this study, please contact:

Dr. Yasmen Simonian at 626-6118 or ysimonian@weber.edu

 

 

Migraine Meeting

 

Who:         Males; ages 20-55 years old

Where:  Weber State University

               Marriot Health Building

               Room # (To Be Determined)

 

When:    (To Be Determined)

 

Participants selected for this study will be

compensated $30.00 upon completion.

 

If you have any questions regarding this study, please contact:

Dr. Yasmen Simonian at 626-6118 or ysimonian@weber.edu

 

 

WANTED:

 

Chronic Migraine Sufferers

to Participate in Clinical Study

 

Who:         Males; 20-55 years old

Where:      Weber State University

                    Marriot Health Building

                    Room # (To Be Determined)

 

When:       (To Be Determined)

 

What:        Clinical study to determine if rapid changes in hormone levels contribute to the onset of migraines

 

Participants selected for this study will be

compensated $30.00 upon completion.

 

 

If you have any questions regarding this study, please contact:

Dr. Yasmen Simonian at 626-6118 or ysimonian@weber.edu

 

This clinical study is directed by WSU’s Clinical Laboratory Sciences Department in conjunction with Davis Hospital and Medical Center



Weber State UniversityOgden, Utah 84408

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