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
Principal Investigator’s Name Principal Investigator’s Signature Date Department
ysimonian@weber.edu,
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
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
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
4. MULTICENTER STUDY
This study will be completed by
5. NUMBER OF SUBJECTS
The total number of male subjects needed for this study is at least 20. All subjects will be tested at
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
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
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
2. EXPERIMENTAL METHODS
This project will be performed in conjunction with
As it is not offered at
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
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
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
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: 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: 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: 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: 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:
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