NCT07233148

Healing ALS Registry Observational Study (HAROS)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Healing Advocates Registry and Ministry · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, observational, online study of people diagnosed with ALS, MND or PLS referred to as HAROS (Healing ALS Registry Observational Study). Participants will enter information into an online ALS registry once per month, including their ALSFRS-R data, certain other symptoms, dietary intake, supplements, medications and other therapies, both conventional and integrative. Participants will also enter the hours spent on optional self-study and free online education. The investigators will assess the effectiveness of various therapies and education by measuring physical outcomes.

Detailed description

There is strong evidence that Amyotrophic Lateral Sclerosis (ALS), Motor Neuron Disease (MND) and Primary Lateral Sclerosis (PLS) are potentially reversible and NOT uniformly-fatal conditions, as reported in the literature. A 12-month 2024 retrospective, observational registry data analysis of 45 ALS patients showed that 85% did better than predicted in the peer-reviewed published literature. In fact, 20% did not lose functionality and 20% actually improved functional status over 12 months. This prospective study seeks to enroll at least 1000 patients diagnosed with ALS, MND or PLS confirmed by their neurologist into this fully-remote, larger, observational study to see if the results of the 45-person ALS data analysis can be substantiated with a larger number of ALS, MND and PLS participants. Participants will be from the USA and other countries. In addition to that primary purpose, the investigators expect to: * determine the efficacy of an integrative medicine approach to ALS (integrative medicine includes conventional medicine, functional medicine and other medical approaches such as acupuncture, frequency medicine and meditation) * assess the effectiveness of self-study and integrative medicine 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 participants commit to updating their information monthly into the online registry for at least one year, preferably for up to 10 years. This takes approximately one hour per month. Participants choose their own treatment protocols based on their own research and input from their healthcare practitioners. Self-study and integrative medicine education is optional but encouraged. Participants in this study can join other research studies at the same time as HAROS, as long as they record in the registry all studies in which they are participating. This study (HAROS) has the potential to improve the prognosis of patients with a diagnosis of ALS, MND or PLS when results are periodically shared about the effectiveness of various treatments and education.

Conditions

• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease (MND)
• Primary Lateral Sclerosis (PLS)

Interventions

Type	Name	Description
OTHER	Education about treatment options	Education about treatment options and integrative therapies is optional. It is available online and is free for all study participants.
DIETARY_SUPPLEMENT	Dietary Supplements: Vitamins, Minerals, Herbs, etc.	The investigators are observing type and quantity of dietary supplements, vitamins, minerals and herbs that ALS/MND/PLS patients take regularly.
BEHAVIORAL	Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.	Many of those diagnosed with ALS/MND/PLS regularly engage in meditation, prayer and other behavioral protocols. These will be observed and analyzed to see if, and to what degree they affect outcomes.
OTHER	Diet, various diets will be observed	May ALS/MND/PLS patients follow a specific diet such as ketogenic, vegetarian, gluten-free, dairy-free, and/or sugar-free. The investigators will analyze which diets are most efficacious.
OTHER	Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies	Exercise, physical therapy, occupational therapy, speech therapy, sauna, massage, EMS (electro-muscular stimulation), red light therapy and other physical modalities will be observed and analyzed for effect on outcomes.
DRUG	ALS medications and other medications	Many ALS/MND/PLS patients find benefit from prescription and other drugs. These will be observed and analyzed for effect on quality of life and outcomes.
OTHER	Physical and emotional support	Study participants are asked to record the level of emotional and physical support they get from family members, caregivers, friends, medical professionals and members of their community. The investigators will analyze how the perceived level of emotional and physical support affect outcomes.

Timeline

• Start date: 2026-01-26
• Primary completion: 2036-02-05
• Completion: 2036-03-31
• First posted: 2025-11-18
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States