Observational studies play a very important role in advancing ALS research—and researchers almost always need more participants. 
​
In observational studies—unlike clinical trials—you do not take an experimental drug or treatment. Instead, researchers observe you and collect information through online surveys, in-person exams, blood draws, and other means.

​Eligibility criteria for observational studies are generally more inclusive than they are for clinical trials—and observational studies often enroll large numbers of participants. If you want to participate in an observational study, you should be able to find one and enroll. Below you will find links to some ongoing studies as well as guidance on how to search for others.
“If you really want to change the course of ALS research and treatment, you can participate in an observational study.” 
​
- Dr. Senda Ajroud-Driss, Northwestern Medicine

Why are observational studies so important?

Observational studies help researchers learn more about ALS, including potential causes, its different types, and how it progresses. This foundational understanding can help advance preclinical research, identify biomarkers, and improve clinical trials—all of which can help accelerate the development of effective treatments.

The Importance of Biomarkers

A biomarker is a measurable indicator of what is happening inside the body that can provide important information about a disease. High cholesterol, for example, is a biomarker that indicates an increased risk for heart disease.

Once biomarkers are identified and proven, researchers can use them to diagnose a disease, measure its rate of progression, see how it responds to a drug during a clinical trial, and more.

ALS observational studies may help researchers identify and validate biomarkers that can improve care and accelerate drug development.

Will I need to travel?

Every observational study is different. Some require in-person visits, some can be done completely from home, and others are hybrid. For some studies, the in-person portion may be integrated into your regular ALS clinic visits. You can ask your clinic team if they are conducting any observational studies and discuss which one(s) might be right for you. 
​
The ALS research community has made significant progress designing more patient-friendly studies that require less travel. This might include tracking symptoms on your own phone, tablet, or computer or having a mobile phlebotomy unit come to your home to draw blood.

Are there different types of observational studies?

Each study has a unique focus and approach. Here are some common types of observational studies:
​
  • Registry studies collect information about medical history, risk factors, and disease progression through surveys and create a database of knowledge for researchers.
  • Natural history studies track disease progression by gathering information over time from people who are either living with a disease or at risk of developing it.
  • Biomarker studies identify and validate biomarkers specific to ALS that can help researchers improve care and advance science.
  • Digital health tech studies gather valuable information from digital devices like smartwatches, accelerometers, and voice recorders.
Data collected in observational studies should be shared with ALS researchers in a way that doesn’t reveal your personal or medical information. Every study requires you to sign an informed consent form that will contain information about how your data will be used and what the study team will do to protect it. If you have any questions or concerns, ask the team how they handle personal data.

What will participation involve?

This depends on the specific study. Before enrolling, ask what is expected of you, how much time you will need to commit, and whether you will be reimbursed if there are any expenses related to study participation.
Observational studies may ask you to do things like:
​
  • Fill out online questionnaires
  • Submit medical records
  • Travel for in-person assessments such as physical exams or breathing tests
  • Provide periodic samples of blood, saliva, or urine
  • Provide periodic speech recordings of your voice​
​The collection of cerebrospinal fluid (CSF) is extremely valuable for ALS research. It is often listed as optional for observational studies.
​
Observational studies have fewer risks than clinical trials, but they are not without risk. Potential risks will be listed in the informed consent form that you review prior to joining the study.

ALS Research for Military Veterans

If you are a Veteran living with ALS, all of the information on this page applies to you. We also encourage you to visit our Veterans Research page to learn about specific considerations and opportunities for Veterans.

Can I also participate in a clinical trial?

Because observational studies don’t attempt to intervene in disease progression, you should be able to participate in a clinical trial and an observational study at the same time. This could vary by trial or study, so always ask the research teams.

Can I enroll in more than one observational study?

You should be able to participate in multiple observational studies at the same time. Different studies collect different types of information, so enrolling in more than one can further advance research. Some large observational studies store participant data in the same database, which means co-enrolling in these studies would result in duplicative data. Ask the research teams just to confirm.

Researchers Also Need Volunteers Without ALS

If you are a caregiver, spouse, family member, or friend of a person living with ALS, you may be able to help advance ALS research. Observational studies often need to gather clinical data and biosamples like blood and cerebrospinal fluid from people without ALS (often referred to as healthy controls or healthy volunteers) to have a point of reference.
​
If you would like to serve in a control group, ask your loved one’s ALS clinic team if they need healthy volunteers for an observational study. You can also search for opportunities by applying a “healthy volunteers” filter on certain online search tools.

Is participation right for me?

People living with ALS often participate in observational studies because they want to help advance ALS research. Observational studies don’t carry the health risks of clinical trials and usually require less of your time, though it is still important to make sure that participating aligns with your priorities.

Ask the study team what will be required. Make sure you can meet the time commitment and other requirements, with support from caregivers or others if needed. Participation in observational studies is voluntary, so if needed, you can withdraw at any time.
“Being involved in research is a way to contribute towards moving the needle closer to finding a cure for ALS. Of course I hope that a successful treatment is available in my lifetime, but in reality, I know that participating in research is for those in the future.
​It is rewarding to be a part of this.”
​
- Stacy Lewin Farber, MD, ALS Warrior & Advocate

Where can I find observational studies?

Start by asking your neurologist if your ALS clinic is a study site. If so, your participation may be integrated into your regular clinic visits. If not, ask if there are any studies currently enrolling in your area.
​
Here are some ongoing observational studies for ALS:
The ALS Research Collaborative (ARC) Study is an observational study from ALS TDI that is open to people living with ALS and asymptomatic gene carriers. You can do everything from home, such as completing online surveys, providing blood samples, and recording your speech. There is no minimum time requirement to participate and you can stop at any time. You can also view your personal data through a secure online portal.
ALL ALS is a nationwide initiative funded by the NIH that aims to advance ALS research and accelerate the development of new treatments by collecting and sharing data and samples from people living with ALS, those at genetic risk, and volunteers without ALS. People living with ALS can participate in-person at a study site or 100% remotely from home. You may enroll regardless of your disease stage or where you live in the U.S.
​The National ALS Registry is a database run by the CDC that collects information from people living with ALS to help researchers better understand potential risk factors and identify areas for future research. Participation involves filling out online surveys about occupational and environmental risk factors such as past military service, work history, physical activities, and family history. You may also provide biological samples such as hair, saliva, and blood for research.
Champion Insights is a fully remote study that seeks to better understand why certain populations—such as military personnel, first responders, and high-performing athletes—are diagnosed with ALS at higher rates than the general public. Researchers are looking to uncover the genetic, environmental, and lifestyle factors that contribute to this elevated risk and believe that findings can inform broader ALS research. Answer ALS, ALS TDI, and Augie’s Quest to Cure ALS are collaborating on this study.
“If not me, then who? I believe in scientific research and I am astonished by what is still unknown about the disease.”
​
- Randy Viscarra, Veteran with ALS
  • The Target ALS Global Natural History Study aims to enroll 800 people living with ALS and 200 healthy controls to create the most comprehensive and globally representative collection of biofluids and data for ALS research. The study collects cerebrospinal fluid (CSF), which is extremely valuable because it provides the most direct window into how ALS affects the brain and spinal cord. Participation involves five in-person visits over the course of 18 months at one of the study locations in the U.S., Puerto Rico, Colombia, Israel, Malaysia, or South Korea. Travel and hotel expenses are reimbursed for the participant and caregiver.

  • The ALS/MND Natural History Consortium collects real-world data from people living with ALS and makes it available to researchers in an effort to better understand disease progression over time, improve care practices, design better clinical trials, and encourage the development of effective therapies. You will first need to find out whether your clinic participates in this study.
  • ​Everything ALS is a nonprofit organization that runs ongoing digital health tech studies that are fully remote, which means you can participate from home. Its speech study seeks to develop digital biomarkers that can help detect ALS earlier and better predict disease progression.​

Genetic Research

An estimated 10% of all ALS cases are believed to have a genetic cause. To learn about observational studies that have a genetic focus, visit our ALS Genetic Research page.

How can I find more observational studies?

​There are many more observational studies for ALS. If you are interested in participating, or are still unsure, you can gather more information by talking with your ALS clinic team, searching for studies online, contacting research study teams, and asking questions.

Additional Resources

  • This webinar on Observational Studies hosted by the Les Turner ALS Foundation explains why observational studies are so important for ALS research.
  • The Participating in ALS Research decision tool from the Les Turner ALS Foundation and NEALS can help you learn about clinical research and decide whether it is right for you.
  • The Learn About Studies page on ClinicalTrials.gov provides helpful information about clinical trials and observational studies.
  • North Star ALS seeks to make ALS research understandable and accessible to families. Its webinar series can help you make research decisions and learn how to engage with care teams and research sites.

ALS RESEARCH GUIDE

Partners and Collaborators