Institutional Review Board Faculty of Medicine McGill University

Project Title: Speech skill learning and retention in persons who stutter and persons with Parkinson's disease

Investigators: Vince Gracco, Ph.D. Associate Professor, McGill University Sarah Smits-Bandstra, Ph.D., Post Doctoral Fellow, McGill University

Introduction: We invite you to be a part of this research project. We are investigating how people who stutter and how people with Parkinson’s disease learn new speaking skills. You have been chosen because you have been previously diagnosed as a person who stutters (PWS) or as having Parkinson’s Disease (PD), or you are being recruited as a control participant. This is a research study and does not involve treatment or therapy. This study will investigate how you learn to say a string of nonsense words (e.g., tapa) by measuring your muscle movements and brain waves. The study will take place at the location most convenient for you either, 1) the Centre for Research on Language, Mind and Brain, McGill University, 3640 rue de la Montagne, Montreal, Quebec, H3G 2A8, or 2) the Fluency Laboratory in Room 1051 of the Rehabilitation Sciences Building, University of Toronto, 500 University Avenue, Toronto Ontario, M5G 1V7. There will be approximately 60 persons participating in this study. The purpose of this study is to help us understand the changes in brain messages and muscle activity that happen while you are learning and whether these learning-related changes are the same in people with stuttering, people with Parkinson’s disease, and healthy control subjects.

What You Will be Asked to Do: All procedures involved in this study are non-therapy testing procedures. The first learning task will be completed in one session lasting approximately 90 minutes. During the first task you will sit in a chair and look at a computer screen. The computer will show you string of nonsense syllables (e.g., ta). You will read aloud the syllables in order. Your face will be videotaped while you are reading the syllables. You will get a chance to practice this task before you start. Practice is included in the 90 minute session. The second learning task will be completed in a separate second session, lasting approximately 90 minutes. The second task will be identical to the first except you will not practice in the second session. After approximately one eek after you have completed Session one, you will be invited to participate in Session two. The study involves recording of your brain activity by means of EEG. EEG is a painless, non-invasive method using sensors attached to a head cap, similar to a swim cap. The sensors do not actually touch your scalp. They are plugged into the head cap holes, after putting in a small amount of water-soluble gel. This gel allows the sensors to read brain activity more easily. The study also involves recording movements of individual muscles in your face by means of EMG. EMG is a painless, non-invasive method using sensors attached with adhesive tape to your face and jaw. These sensors are easily removed by hand when the study is complete. After the experiment you may wish to wash and dry your hair and face. If so, a towel, soap, and shampoo will be provided.

Speech skill learning in persons who stutter and persons with Parkinson’s disease Version date: January 22, 2008 Speech skill learning in persons who stutter and persons with Parkinson’s disease Version date: January 22, 2008 Risks: This study does not involve any foreseeable risk, harm or inconvenience to you. EEG has been used in the past in many studies with no significant side effects reported. You may experience a minor headache due to the pressure exerted by the cap. The frequency of headaches due to the cap is quite low (less than 10%).

Benefits: Participation in this study will be of no direct or indirect benefit to you. EEG and EMG are tests, not treatments. It is hoped that the information obtained this study will contribute to our understanding of the factors which affect speech therapy for people who stutter and people with Parkinson’s disease.

Compensation: For participation in two 90 minute sessions you will receive $80.00 for your time and inconvenience. This amount of compensation includes any local transportation costs and parking. If you withdraw before the end of the study, you will be compensated proportionate to your time in study.

Subject Rights: Your participation in this research project is voluntary. You have the right to decline to answer any question or complete any part of the screening or the experiment and you may withdraw from the study at any time without prejudice or consequences for current or future care and/or access to speech therapy services. You are under no obligation to sign this consent form and may withdraw from this study at any time. You have the right to ask questions at any time, concerning the procedure, material, results, etc.

Access to Information: No one, with exception of the investigators and members of the McGill University Institutional Review Board, will have access to your personal data. All records with personal information and all videotapes of you will be kept in a locked filing cabinet in a locked room and all possible security measures will be taken to ensure any identifying information is kept confidential under any and all circumstances until they are destroyed (shredded and erased) six years from the date listed below. Six years from the date of this study all paper documents containing identifying information about you will be shredded and all videotapes of you will be erased. You have the right to access your results. You can find out about the results of this study by contacting Dr. Sarah Smits-Bandstra (see below). You will be informed in a timely manner if information becomes available that may be relevant to your willingness to continue to participate in this research. This research project is funded by the Canadian Institute of Health Research.

Confidentiality: Your results will be kept confidential. No personal information will be released to third parties without your written approval. Your confidentiality will be ensured by allocating a code to each of the data sets so that no one will be able to decipher your identity. In cases where your particular results have to be discussed, this will be done by preserving your anonymity. If you withdraw from the study at any time all of the data collected from your session will be destroyed immediately and will not be used in research or public presentations. The people running this study intend to publish the research and to make public presentations based on the research. Understand that neither your name nor any other identifying information will be used in any publication or discussion about this study and that all information about you will remain confidential.

Speech skill learning in persons who stutter and persons with Parkinson’s disease Version date: January 22, 2008 Throughout the study, all data (with no personal or confidential information) will be preserved in a locked filing cabinet in a locked room at Centre for Research on Language, Mind and Brain, McGill University, – access to which will be restricted to the Principal Investigator and Co-investigator. Following the study, all materials will be retained for no less than 25 years, in this same secure storage facility. Following the storage period, all trial materials will be destroyed by a secure document disposal company.

Contact: If you have any questions please contact Dr. Gracco or Dr. Smits-Bandstra at the School of Communication Sciences and Disorders, 1266 Pine avenue West, Montreal, Qc, H3G 1A8, Phone: 514- 398-7386. If you have any concerns regarding ethical issues in the research please contact Ilde Lepore, Senior Ethics Administrator, 514-398-8302.

I have had the nature of the study explained to me and I agree to participate. All questions have been answered to my satisfaction. A copy of this consent form will be given to the participant. I do not waive my legal rights by signing this consent form.

SIGNATURE ______SUBJECT DATE

SIGNATURE ______PERSON WHO OBTAINED CONSENT DATE

Speech skill learning in persons who stutter and persons with Parkinson’s disease Version date: January 22, 2008