Patient Registries

Episodic Ataxia Registry

The purpose of this contact registry is to provide an opportunity for individuals with Episodic Ataxia to register themselves to receive information about studies conducted by the Rare Disease Clinical Network.

Cooperative Ataxia Registry (CAG)

A New Registry for Ataxia Patients
By Chip Wilmont, MD, Ph.D. and Sue Gronka, R.N.
The Emory Ataxia Center
Emory University School of Medicine

Register through the Cooperative Ataxia Group website at: www.cooperative-ataxia-group.org/participate.htm

Because the ataxias are such a rare and diverse group of disorders, researchers can have a hard time finding enough patients to conduct their studies. What is really needed is a large-scale resource that can foster cooperation between patients and researchers. To address this goal, we have recently established a registry of North American ataxia patients entitled The Cooperative Ataxia Registry. The registry will be a tool used to gather information about these rare diseases and to match patients interested in participating in research projects with researchers looking for eligible subjects. We believe this registry can serve as a major resource for the development of basic scientific, clinical research, and ultimately treatment protocols.

How does the registry work? The overall scheme is simple: with the patient's permission, we collect contact information and medical history data and store that information very securely here at Emory University. We then distribute data to researchers in a way that ensures complete confidentiality of all information. Specifically, if a patient decides to participate in the registry, they will be required to sign all three forms and complete a patient questionnaire. These forms can be obtained by contacting the registry office by phone (404-778-5905), via email request (TheEmoryAtaxiaCenter@emory.edu), or by printing out the forms from the Cooperative Ataxia Group website (www.cooperative-ataxia-group.org/participate.htm). The first form is an informed consent. This document provides information about the registry and details about participating in the study. The second form is a HIPAA form that talks about privacy and how we will protect personal health information. The third form is an authorization for release of medical records. We will forward this form to the participant's physician so that we can obtain a copy of the medical records that will include neurological exams, genetic testing results, radiology reports, laboratory results and any other information pertaining to the diagnosis of ataxia. The last document to fill out is the patient information form. This questionnaire provides us with data about the individual patient and their experience with ataxia, and will help us to understand more about ataxia. It will also help us contact the patient in the future regarding studies in which they may be eligible to participate. After completing all of these forms the patients will mail of fax them to the registry office (see contact information below). This is all that is required to participate in the registry.

Since we are collecting large amounts of personal information, we designed the registry to be secure and we take the issue of confidentiality very seriously. At no time will we dispense information that can identify a patient personally. When the forms and records are received they are stored in a locked office in a secured filing cabinet. The computer database in accessible only by Dr. Wilmont and personnel in the registry office. To ensure patient confidentiality, the registry will support two different types of research studies from outside researchers. The first type of study will include protocols that require contact with eligible patients. Ataxia researchers will submit these protocols along with an information sheet that will provide a brief description of the study. Once the protocol is reviewed and approved, we will submit these protocols along with an information sheet that will provide a brief description of the study. Once the protocol is reviewed and approved, we will scan the database to identify potentially eligible subjects. The patients that we identify will then be contacted by the registry and they will be provided with a description of the study and a way to contact the study's coordinator. It will be up to the patient to determine if they are interested in calling the study coordinator. A patient will be under no obligation to volunteer for a study. The registry will never release a name or contact information directly to the researcher.

The second type of study is protocol that does not require contact with or personal information about a patient. This type of study would be looking at data that is stripped of all identifying information. Researchers will submit this type of approved protocol to the registry and the registry will compile the requested data but will not provide any identifying information and will not contact any patients in the registry.

In March 2005 we received approval to begin entering patients into the registry. Since that time, 145 people have requested to participate in the registry. Ataxia patients from 32 states and 4 Canadian provinces are represented in the group. The registry has already helped to identify subjects for one research study. This progress is exciting, but very preliminary. We hope to enroll two to three thousand more patients over the next few years.

Please note that there are other ataxia registries in existence in North America and our registry is not meant to take the place of these other local or disease-specific registries. Because of privacy issues, we cannot share our information with those registries and they cannot share their information with us. However, as we discussed above, if you participate in the Cooperative Ataxia Registry we can make you aware of other registries so that you can participate in them as well.

Please contact us if you have any questions about the Cooperative Ataxia Registry. We can be reached at:
The Emory Ataxia Center Department of Neurology
1365 Clifton Road, N.E.
Atlanta, GA 30322
Tel: (404) 778-5905
Fax: (404) 778-3495
E-mail: TheEmoryAtaxiaCenter@emory.edu
Register through the Cooperative Ataxia Group website at: www.cooperative-ataxia-group.org/participate.htm

First, we can give registry data to researchers who need general data that is completely stripped of identifying information. For instance, we can respond to requests by ataxia researchers who want to know the most common first symptom for Friedreich's ataxia, or the number of SCA1 patients living west of the Mississippi. Second, we will also keep a file of information that we collect from the patient and the patient's physicians in a secure file cabinet in the registry office at Emory University. This data will be used in the future to help identify aspects of the disorders to study, people who may be eligible for specific studies, and will be used to contact participants about research projects in which they might be interested in participating. Patients can talk with their doctor about participation or can call the registry office (at the above number) if more information is needed.