Information for Study Applicants/Participants
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Study Title: Healing ALS Registry Observational Study (HAROS)
Principal Investigator: David K. Calderwood MD
Institution: Healing Advocates Registry and Ministry
Websites: HealingALS.org, ALSRegistry.org
Study Begin Date: 1/26/2026, ongoing recruitment
Study Duration: Minimum 1 year, up to 10 years
Study Sponsor: Healing Advocates Registry and Ministry
Study Funding: This study is funded by donations from patients with ALS, their families, their friends and businesses. No pharmaceutical company nor government agency has funded this study.
Clinical Trials Link: https://clinicaltrials.gov/study/NCT07233148
To sign up for the Study: healingals.org/haros/
Questions? healingals.org/haros/
Key Information for this Research Study
We are inviting you to take part in an observational research study on patients with a neurologist’s diagnosis of “Amyotrophic Lateral Sclerosis (ALS)”, “Primary Lateral Sclerosis (PLS)” or “Motor Neuron Disease (MND)”. Your participation in this study is completely voluntary. Since this study is purely observational, you and your healthcare practitioners decide the best choices of evaluation and treatment for you. There are no required tests nor therapies in order to participate. We request that you record online what tests, diet and therapies you have done and what changes in symptoms you have experienced by completing the Healing ALS Registry each month.
Purpose of this Research Study
We have strong evidence that ALS, MND and PLS are potentially reversible and NOT uniformly-fatal conditions, as most neurologists tell their patients. Our one-year-long 2024 observational registry study of 45 ALS patients showed that 85% of them did better than predicted by their neurologists and by the peer-reviewed published literature. In fact, 20% did not lose functionality and 20 % actually improved functional status over 12 months.
The purpose of this larger study is to see if the results of the 45-person ALS observational study can be substantiated with a larger number of ALS participants. In addition, we expect to determine
- the efficacy of an integrative medicine approach to ALS
- the importance of self-study and ALS education programs on ALS outcomes
- track data to analyze the most effective treatment protocols that ALS patients are currently engaged in and correlate with clinical outcomes
- explore and analyze possible causative factors and their treatments on outcomes using advanced data analysis
Study Duration
Each study participant commits to study participation for at least one year. Study participants will have the option of continuing to be part of the study indefinitely if they meet the requirements. Study participants can withdraw from the study at any time by sending an email to study@healingals.org.
Study duration is ongoing for 10 years. Once the study begins, new study participants will be allowed to enroll periodically during open enrollment.
Study Procedures
BASIC REQUIREMENTS
- Study participants must be at least 18 years of age and be a non-smoker.
- Anyone diagnosed with ALS, MND or PLS may participate in the study, regardless of date of diagnosis.
- Study participants may reside in any approved country. Approved countries are: United States. More countries will be added as we obtain ethical approval in each country.
- Anyone who does not speak English may enroll, however, each participant is responsible for translation. Many of the web pages on alsregistry.org (for Tracking and Research) and healingals.org (for Education) have auto-translate capability. Each participant is responsible for accuracy of translation.
- Although study participants agree to participate in the HAROS (Healing ALS Registry Observational Study) for a minimum of one year, they have the option to withdraw and discontinue participating in the study at any time by notifying study administrators at study@healingals.org.
APPLICATION PROCESS
Study participants follow the Application process outlined below. Participants who have challenges entering data are strongly encouraged to have a friend or family member assist with the application process. The application process is described below.
Applicants
- Each study applicant must join the Healing ALS Registry (alsregistry.org) and consent to Terms and Conditions, then:
- Complete the Profile Tabs 1, 2 & 3 (1 hour)
- Upload neurologist report or letter confirming a diagnosis of ALS, MND or PLS
- Complete the first Monthly Check-in (1-1.5 hours)
- Each study applicant must read and understand this Study Information document that you are currently reading
- Each study applicant must have completed the 7 Day Quick Start Essentials Course on HealingALS.org (12 hours)
- Each study applicant must fill in the Healing ALS Observational Study Application (1 hour)
Study Administrators
- Study administrators will review each application and inform applicant by email if the application is approved
- Whether or not the applicant is admitted to the study, all information will be kept strictly confidential
Accepted Applicants
- While in the study, participants (often with the help of caregivers) are required to complete the monthly check-in at alsregistry.org by the 5th day of each month after acceptance (about 1 hour per month).
- While in the study, participants will have Free access to the 47 Steps to Healing Course as long as data is entered by the 5th day of the month.
- While in the study, participants will have Free access to other online education including webinars, Q&A sessions, and peer support
- For more information, questions or concerns, please contact study@healingals.org.
OTHER STUDY DETAILS
The ALS Registry employs industry-standard security practices to protect private health information (PHI), the security features of Firebase and Firestore. By implementing encryption at rest and in transit, strict access controls, regular encrypted backups, and adhering to data retention and destruction policies, we ensure the confidentiality, integrity, and availability of sensitive data.
- ALL data stored is de-identified and encrypted by the registry software so that patients remain anonymous.
- Participation in online and other education is voluntary. It is the experience of the Healing ALS community that those who participate in the online education have a slower progression of ALS symptoms than those who do not
- Only approved researchers will have the right to access de-identified (stripped of private information) data.
- Study participants may have access in the future to de-identified data of fellow participants.
- All of the information presented by Healing ALS or any of its agents or speakers is intended for educational purposes only and is not medical advice.
- All health care choices that participants make are of their own free will based on their own research, advice from their own medical practitioners and other sources.
What Are Reasons You Might Choose to Volunteer for this Study?
To be part of cutting-edge ALS research, to help yourself and your own support team find effective therapies for ALS.
- Free integrative medical/health education potentially worth thousands of dollars will be provided for the registry study participants.
- The 45 ALS patients in the 2024 pilot study made use of this free education, with 85% of the participants having a better outcome than predicted by their neurologists and the medical literature
- Since study participants’ information is in one place, each participant can easily review what combinations of therapies they have used and the outcomes.
- Study participants have the ability to print or download their data entered into the registry to share with their health practitioners or others.
- You will be helping ALS research and therefore helping to establish effective treatment protocols for others diagnosed with ALS around the world. Approved researchers will have access to de-identified data.
- If study participants have access in the future to de-identified data, participants can learn first-hand about the effectiveness of various therapies for ALS.
What Are Reasons You Might Choose Not to Volunteer for this Study?
- The study requires time to enter data each month (1 hour per month).
- It takes time to study, learn and apply the information presented. Alternatively, based on the 45-person study in 2024, those who spent time learning and applying healing strategies had a slower progression than those who did not.
Risks Associated with this Stud
- Since this is an observational study there is no significant risk to the participant other than loss of time that could have been used in other activities.
Alternatives to this Study
Persons with ALS may choose any or any combination of the following
- Do nothing and enjoy the years they have left.
- Participate in a pharmaceutical trial of a medication for ALS treatment. (You can do this and still participate in HAROS).
- Study possible ALS treatment strategies on your own without the benefit of HealingALS.org.
Future Use of Data
De-identified information could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you or your legally authorized representative.
Contact: If you want to speak to someone or ask questions before joining the study or any time after you have enrolled in the study, send an email to study@healingals.org.
Revision History:
Revised Feb 5, 2025 to reflect actual Study Begin date of Jan 26, 2026 and add sponsor and clinical trials link.
Revised Jan 19, 2026 to change estimated Study Begin date to 1/20/2026 and to make wording more clear for application process, study details and future studies.
Revised Dec 19, 2025 to add Study duration of 10 years, and approved countries
Revised Dec 2, 2025 to update Study Begin Date to 1/1/2026
Revised May 12, 2025 to include data security, risks, alternatives and future use.
Published April 16, 2025