Together We Can Advance SPS Research
The Stiff Person Syndrome (SPS) Global Registry is funded and sponsored by The Stiff Person Syndrome Research Foundation (SPSRF). It was built in collaboration with patients, caregivers, clinicians, researchers, and data experts.
The SPS Global Registry will serve as a pivotal resource to unite the global community, centralize data, and help advance SPS research.
Our mission is to give patients, clinicians, researchers, and industry the opportunity to learn from one another and work together to advance treatments and care for patients who live with the burden of SPS every day.
Amanda Piquet, MD
Associate Professor of Neurology
Director, Autoimmune Neurology, University of Colorado
“Stiff person syndrome (SPS) is often misdiagnosed and likely underdiagnosed. I cannot think of a better organization outside of the SPSRF to lead this critical initiative that will be pivotal to our understanding of the disease and treatment landscape of this challenging disorder."
SPS Global Registry FAQs
Why Participate?
Your participation will give you a seat at the research table to help advance knowledge and treatments for SPS.
Patient
Empowerment
Participation will empower the patient community to impact research and improve their lives.
Pool Data and Resources
Participation will contribute to the centralization of SPS data and resources which will help advance research efforts.
Impact Patient
Outcomes
Participation will help researchers and clinicians better understand SPS and its burden, leading to improved outcomes and quality of life for patients.
Global Research Collaborations
Participation will support global research collaborations to improve treatments and patient care around the world.
-
To conduct a natural history study (NHS) that will lead to a better understanding of SPS and its course.
-
To characterize patients with SPS and identify their SPS-related symptoms.
-
To better understand the patient burden of SPS and how SPS affects their quality of life.
-
To better understand the diagnostic journey of patients with SPS.
-
To gather information about therapeutic interventions and outcomes for patients with SPS.
-
To establish a pool of patients with an SPS diagnosis to participate in SPS research efforts.
-
To create a biorepository linked to the SPS Global Registry.
-
To encourage and support international SPS registry and research collaborations.
-
The SPSRF is the Registry's research study sponsor. As sponsor, they are responsible for choosing appropriately trained and experienced researchers to conduct the study. They are also responsible for managing the Registry, reporting to an Institutional Review Board (IRB) mandated by the government, and overseeing regulatory compliance. Additionally, the sponsor is responsible for the costs associated with the Registry. The SPSRF ensures that the study is conducted in a reputable, ethical manner and upholds regulations as they apply to the study.
An IRB is a board formally designated by an institution or investigator to review, approve the initiation, and conduct periodic reviews of research involving people. The primary purpose of such an assessment is to ensure the protection of the rights and welfare of the participants in the study. This is also known as an Ethics Committee (EC) or Research Ethics Board (REB in Canada).
This study is open to anyone who has a confirmed diagnosis of SPS by a physician.
There is no cost to participate in the Registry.
The data collected includes details about:
Socio-demographics
Medical History
Women’s Health
Social History
Family Medical History
SPS Diagnosis and Testing
Medical Uploads
SPS Symptoms
SPS Treatments
Quality of life
Data is collected through a secure web-based application (that can be accessed by computer, tablet or phone) developed by the National Organization for Rare Disorders, Inc. (NORD®). Study participants respond to questions grouped within a series of surveys developed per study standards and in collaboration with disease-specific experts.
NORD, an independent nonprofit, is leading the fight to improve the lives of rare disease patients and families. NORD supports the rare community, its people, and its organizations, working together to accelerate research, raise awareness, provide valuable information, and drive public policy that benefits the estimated 25-30 million Americans with rare diseases.
Learn more about NORD at https://rarediseases.org/.
The Registry follows strict government guidelines to ensure patient information is protected. The platform is served over HTTPS, meaning the data is encrypted when sent from the user’s browser to the NORD servers. The data is also kept encrypted in the NORD database. Communications between the registry platform application server and the database are also encrypted. As with any information you provide electronically, there is a rare chance that your privacy could be compromised. However, the registry and the security measures minimize the possibility of this occurring.
The study sponsor owns the study data. The SPSRF decides how and with whom to share the data. NORD staff will have access to the data for activities related to support and maintenance of the Platform and will collect Platform-wide participation statistics. The specifics will be outlined in your informed consent.
All data, including those with Personal Health Information (PHI), will be stored in a password-protected secure server. Access to PHI will be limited to:
Approved members of the SPS Global Registry research team
NORD staff, in cases where technical support is needed and with the permission of registry staff
With agreement from the Sponsor, NORD may conduct IRB-approved, cross-disease research using registry data.
In all cases, your privacy will be protected.
The sponsor will analyze the data to conduct research and share it with researchers to achieve their study objectives. Data containing personal health information (PHI) will only be shared if the research cannot be done without it. Otherwise, all data will be de-identified (excluding PHI) before being shared in aggregated (participants combined data) reports. The Principal Investigator (PI) and Registry Steering Committee will evaluate all requests for data from researchers and approve them before it is released. The SPSRF has strict governance policies for data sharing.
A Registry Steering Committee is a group of experts that includes patients, caregivers, clinicians, researchers, and data specialists who advise the sponsor on developing, implementing, and managing the registry.
The Principal Investigator (PI) is the person with the primary responsibility for designing and conducting the research project or study. The PI is responsible for overseeing all aspects of the Registry, its staff, and the research on the data contained within.
A Study Participant is the individual about whom information is entered into the registry. In the case of an independent person of legal age, this individual will consent for and enter information about themself. If an individual is not of legal age or is an adult who requires someone to act on their behalf, a person (Caregiver/LAR, see below) legally responsible for their health care will provide consent and enter information about the Study Participant.
An LAR is authorized under applicable law to consent and enter data in the registry on behalf of another individual. The LAR may be a parent, grandparent, spouse, caregiver, or guardian as long as they have the legal authority to grant consent on behalf of that individual. An LAR will sign up on the IAMRARE platform with a Caregiver account. When an LAR acts on behalf of a study participant, they are considered the reporter in the research.
A Designated Representative is a legal adult who was the caretaker of an individual with SPS who passed away. This may be a spouse, parent, sibling, offspring, close relative, close friend, guardian and/or significant other of this individual. This person must have known of and participated in the deceased's medical care. These individuals are permitted to enter retrospective data on their behalf.
An ICF document provides potential participants with crucial information about the registry. This document helps potential participants to make an informed decision whether to join or not. Information will include topics such as the risks and benefits of the research project, use of data, and participant privacy. If they choose to join the study, participants must electronically sign the ICF. This indicates that they agree to the terms as described before entering data into the registry or responding to surveys.
Participants can withdraw from the study at any time. However, information already used for research before the participant changed their mind cannot be cannot be retrieved.
Together, we can make a difference for those living with SPS.
The SPS Global Registry gives the patient community a way to proactively share their knowledge and experience living with SPS to help advance research, treatments, and care.
With the support of the patient community, clinicians, researchers, and industry can better understand the needs of patients, the gaps in research, and how to design the most effective studies for SPS. Working together, all parties can help those affected by SPS and one day find a cure!
For further inquiries or information, please contact us at registry@stiffperson.org.
Register Below
Follow this link to register on the SPS Global Registry
Provide Consent
Provide consent for participating in the Registry as a patient, Legally Authorized Representative (LAR), or Designated Representative.
Complete New Surveys
Complete the registry surveys, which consist of questions about the patient’s journey with SPS.
Provide Updates
Update the registry surveys when notified to ensure quality data, which will continue to help advance SPS research.
Participation Feedback
Look at the data analysis reports to see how your participation helps advance SPS research.
How to Participate in the SPS Global Registry
What Is A Registry?
A patient registry is a collection of standardized information about a group of patients who share a condition.
The information can be used for different purposes, including connecting patients, conducting natural history studies that track the course of conditions over time, and supporting clinical trials.
The SPS Global Registry is powerful because it is driven by patients who own their data and can choose to share it from anywhere in the world.
Why Is It Important?
-
It gives the patient community a voice at the research table. By sharing their everyday experience with SPS, patients will help advance the understanding and knowledge of this rare debilitating condition.
-
It centralizes SPS data, including patient records, to help advance research, improve treatments, and eventually find a cure.
-
It connects the global community, providing support and knowledge for patients and their loved ones.