Research Study on Dizziness and Imbalance

CONSENT TO PARTICIPATE IN RESEARCH

 EYE-HEAD COORDINATION AND EYE MOVEMENT TESTS

You are asked to participate in a research study conducted by Joseph L. Demer, M.D., Ph.D., and Jun-ru Tian, M. D. Ph.D. from the Departments of Ophthalmology and Neurology at the University of California, Los Angeles. You have been asked to participate in this study because you have normal balance and are in good health or may have balance and/or eye movement problems. We anticipate enrolling approximately 80 volunteers per year in this study. Participation in this research study is voluntary. You should read the information below, and ask questions about anything you do not understand, before deciding whether or not to participate.

PURPOSE OF THE STUDY

The purpose of this research is to improve understanding of how the balance and visual systems interact to coordinate the movements of the eyes and head. By developing better methods of measuring balance and eye movements we hope to improve the diagnosis and treatment of the diseases causing dizziness.

PROCEDURES

This research typically involves between one and three test sessions, all performed at UCLA, lasting about one hour each for must subjects. Depending upon the course of the research and on your condition, you might be asked to participate in additional sessions. Scientific information is obtained from each individual test session, but greater information is derived from comparison of results of different tests in the same person, and sometimes from repetition of tests over a period of time of up to several months in people who have certain balance problems. The exact number of test sessions in your case will be suggested by Dr. Demer and Dr. Tian, but only if you are agreeable to this. The time between test sessions will vary from one day to several months, depending upon technical developments in the laboratory.

If you volunteer to participate in this study, we would ask you to undergo the following:

1. Medical history. We will ask you questions about your past health. You have the right to refuse to answer any question that you may not wish to answer.

2. Physical examination. Joseph L. Demer, M.D., Ph.D. and Jun-ru Tian, M.D, Ph.D. will conduct a physical examination consisting of standard clinical tests of vision, eye movements, and balance.

3. Balance, eye movement, and vision tests. The following tests are administered by Joseph L. Demer, M.D., Ph.D., Junru-Tian, M.D., Ph.D. or a trained research associate under the supervision of a physician:

a. Tests in which your eyes track a moving visual target or display.
b. Tests which apply a turning or sliding motion to the subject as you sit in in a motorized chair. These tests are performed in the dark and in the light.
c. Tests of balance in which you stand on a platform that moves or tilts slightly.
d. Tests of eye-head coordination during natural activities such as standing, walking, running, or active movement of the head.
e. Tests of vision during motion of your body or of the eye chart.
f. Tests in which the balance organs are stimulated by warm and cool water placed in the ear.

Eye movements will be recorded by one or more or three different methods: 1) electrodes pasted onto the skin near the eyes (electro-oculography), 2) devices that track the eyes using light (optical tracker) and, 3) an instrumented soft magnetic search coil contact lens that is placed on the sclera (white part of the eye). The scleral magnetic search coil contact lens method is needed because it offers much higher accuracy than the other methods, and is the only suitable method for many types of eye movements. A drop of local anesthetic is applied to the eye before the scleral magnetic search coil contact lens is placed. The scleral magnetic search coil contact lens remains on the eye for up to 30 minutes in each test session. We have used the scleral magnetic search coil contact lens method for recording eye movements in more than 400 subjects. To minimize any potential risk the scleral magnetic search coil contact lens will be placed on the eye by an experienced physician (Joseph Demer, M.D., Ph.D. or Junru Tian, M.D., Ph.D.) or by a trained research associate under the supervision of one of these physicians.

Head movements are measured by a sensor attached either to a snug headband, or attached to a dental mold custom fitted to the upper teeth. The headband should be snug but not uncomfortable, and has no known risks. The dental mold is made by biting into soft plastic material that hardens after removal from the mouth into the impression of the upper teeth.

POTENTIAL RISKS AND DISCOMFORTS

No long-range effects are known to occur from the range of stimulation used in these tests. Some subjects may develop a feeling of dizziness during the movement tests, occasionally nausea and rarely vomiting. Some subjects may feel lightheaded or faint during the wearing of the scleral magnetic search coil contact lens, as is the case for any medical procedure that involves contact with the eye. Should lightheadedness or faintness occur these effects resolve within minutes after removal of the lens.

Electro-oculography and optical tracking of eye movements are routinely used and have no significant risks. The scleral magnetic search coil contact lens method could possibly lead to irritation or abrasion (a scratch) of the surface of the eye. If corneal abrasion should occur, it is treated with a drop of antibiotic solution and the eye is patched for approximately 24 hours. Corneal abrasions can be painful and may be accompanied by headache but typically heal quickly without any effect on vision. Any irritation or redness from the contact lens itself typically disappears within minutes after the lens is removed.

The dental mold used for head movement measurement is used only by the person from whom the impression has been taken, and has no risks except that some people will need to swallow saliva frequently when the mold is held in the mouth.

In order to avoid over-exertion, during tests of eye-head coordination during natural activities, you will not be asked to exert yourself beyond your customary level of activity. If you feel tired, you should request a rest period or discontinuation of the physical activity.

The research procedures may involve risks that are currently unforseeable.

ANTICIPATED BENEFITS TO SUBJECTS

Normal subjects participating in this study will derive no specific benefit except for financial reimbursement. If you are a patient, you should not expect your condition to improve as a result of participating in this research, and your condition could become worse despite participation in this research project. No appropriate alternative procedures for conducting these tests are known.

ANTICIPATED BENEFITS TO SOCIETY

This research is furthering the understanding of balance and eye-head coordination in the large number of people afflicted with dizziness and similar disorders. The research is evaluating new methods for the diagnosis and evaluation of balance function that could be applied to large numbers of patients.

ALTERNATIVES TO PARTICIPATION

Patients with known or suspected balance disorders may undergo testing of balance and inner ear function by traditional methods without enrolling in the study, and without use of the scleral magnetic search coil contact lens.

Your health care provider may also be an investigator of this research protocol, and as an investigator, is interested not only in your clinical welfare, but also in the results of this study. It is possible that occasionally these two goals may be in conflict. Before entering this study or at any time during the research, you may ask for a second opinion from another doctor who is in no way associated with this project. You are not under any obligation to participate in any research project offered by your physician.

PAYMENT FOR PARTICIPATION

Not every participant will participate for the same duration and number of tests and procedures. If you drive to UCLA and must pay for parking during your research test, we will reimburse you $5.00 for the parking charge. Volunteer subjects will be reimbursed for participation at one of two different rates: 1) $10.00 per hour for testing not involving the search coil contact lens; and 2) $30.00 per session involving use of the scleral magnetic search coil contact lens in one eye; and 3) $40.00 per hour for testing involving use of the scleral magnetic search coil contact lens in both eyes. Tests involving one or two search coil contact lenses ordinarily involves about one hour of total time and 30 minutes of wearing the scleral magnetic search coil contact lens. If a full test session is not completed due to your withdrawal from the research or due to discontinuation of testing by the investigators, the rate of reimbursement will be prorated on the basis of one hour for a full test session.

FINANCIAL OBLIGATION

There will be no charges or costs to volunteer subjects for tests and procedures performed in this project for research purposes. Neither you nor your insurance company will be billed for your participation in this research.

EMERGENCY CARE AND COMPENSATION FOR INJURY

If you are injured as a direct result of research procedures not done primarily for your own benefit, you will receive treatment at no cost. The University of California does not provide any other form of compensation for injury.

PRIVACY AND CONFIDENTIALITY

The only people who will know that you are a research subject are members of the research team and, if appropriate, your physicians and nurses. No information about you, or provided by you during the research, will be disclosed to others without your written permission, except if necessary to protect your rights or welfare (for example, if you are injured and need emergency care), or if required by law.

PARTICIPATION AND WITHDRAWAL

Your participation in this research is VOLUNTARY. If you choose not to participate, that will not affect your relationship with UCLA (or UCLA Medical Center), or your right to health care or other services to which you are otherwise entitled. If you decide to participate, you are free to withdraw your consent and discontinue participation at any time without prejudice to your future care at UCLA.

WITHDRAWAL OF PARTICIPATION BY THE INVESTIGATOR

The investigator may withdraw you from participating in this research if circumstances arise which warrant doing so. If you become uncomfortable of ill during the research, you may have to drop out, even if you would like to continue. The investigators, Joseph L. Demer, M.D., Ph.D., and Jun-Ru Tian, M.D., Ph.D., will decide if it is not possible for you to continue. The decision may be made either to protect your health and safety, or because it is part of the research plan that people who develop certain conditions may not continue to participate.

If you must drop out because the investigator asks you to (rather than because you have decided on your own to withdraw), you will be paid pro-rata for the time you have spent during the research.

NEW FINDINGS

During the course of the study, you will be informed of any significant new findings (either good or bad), such as changes in the risks or benefits resulting from participation in the research or new alternatives to participation, that might cause you to change your mind about continuing in the study. If new information is provided to you, your consent to continue participating in this study will be re-obtained.

IDENTIFICATION OF INVESTIGATORS

In the event of a research related injury or if you experience an adverse reaction, please immediately contact one of the physician investigators listed below. If you have any questions about the research, please feel free to contact:

Joseph L. Demer, M.D., Ph.D. (310) 825-5931, office and 24 hour pager

Jun-Ru Tian, M.D., Ph.D. (310) 825-8122 office; (310) 825-6301 pager

Nicolasa De Salles, B. S. (310) 206-6354 office; (310) 825-6301 pager

The investigators can be reached by mail at:

Jules Stein Eye Institute, 100 Stein Plaza, UCLA, Los Angeles, CA. 90095-7002;

or via fax at (310) 206-7826.

RIGHTS OF RESEARCH SUBJECTS

You may withdraw your consent at any time and discontinue participation without penalty. You are not waiving any legal claims, rights or remedies because of your participation in this research study. If you have questions regarding your rights as a research subject, you may contact the Office for Protection of Research Subjects, 2107 Ueberroth Building, UCLA, Box 951694, Los Angeles, CA 90095-1694, (310) 825-8714.

SIGNATURE OF RESEARCH SUBJECT

I have read (or someone has read to me) the information provided above. I have been given an opportunity to ask questions and all of my questions have been answered to my satisfaction. I have been given a copy of this form, as well as a copy of the Subject's Bill of Rights.

BY SIGNING THIS FORM, I WILLINGLY AGREE TO PARTICIPATE IN THE RESEARCH IT DESCRIBES.

SIGNATURE OF INVESTIGATOR

I have explained the research to the subject, and answered all of his/her questions. I believe that he/she understands the information described in this document and freely consents to participate.