Healing ALS Registry Observational Study (HAROS)

Overview

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.

Interventions

• 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.

Primary outcome measures

• ALSFRS-R ALS Functional Rating Scale - Revised [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• ALSSQ ALS Supplementary Questionnaire [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Mindset Score [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]

Secondary outcome measures (12)

• Weight [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood inflammation markers Set 1 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood inflammation markers Set 2 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood oxidative stress markers Set 1 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood oxidative stress markers Set 2 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood essential nutrient levels Set 1 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood essential nutrient levels Set 2 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood essential nutrient levels Set 3 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood essential nutrient levels Set 4 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood essential nutrient levels Set 5 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood insulin resistance markers Set 1 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]
• Change in blood insulin resistance markers Set 2 [Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.]

Eligibility criteria

Inclusion criteria

• Diagnosed with ALS, MND or PLS

Exclusion criteria

• Smokers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Virtual — Park City

Publications

• Boddy SL, Giovannelli I, Sassani M, Cooper-Knock J, Snyder MP, Segal E, Elinav E, Barker LA, Shaw PJ, McDermott CJ. The gut microbiome: a key player in the complexity of amyotrophic lateral sclerosis (ALS). BMC Med. 2021 Jan 20;19(1):13. doi: 10.1186/s12916-020-01885-3. PMID 33468103
• Peters S, Broberg K, Gallo V, Levi M, Kippler M, Vineis P, Veldink J, van den Berg L, Middleton L, Travis RC, Bergmann MM, Palli D, Grioni S, Tumino R, Elbaz A, Vlaar T, Mancini F, Kuhn T, Katzke V, Agudo A, Goni F, Gomez JH, Rodriguez-Barranco M, Merino S, Barricarte A, Trichopoulou A, Jenab M, Weiderpass E, Vermeulen R. Blood Metal Levels and Amyotrophic Lateral Sclerosis Risk: A Prospective Coh PMID 33068316
• Filippini T, Tesauro M, Fiore M, Malagoli C, Consonni M, Violi F, Iacuzio L, Arcolin E, Oliveri Conti G, Cristaldi A, Zuccarello P, Zucchi E, Mazzini L, Pisano F, Gagliardi I, Patti F, Mandrioli J, Ferrante M, Vinceti M. Environmental and Occupational Risk Factors of Amyotrophic Lateral Sclerosis: A Population-Based Case-Control Study. Int J Environ Res Public Health. 2020 Apr 22;17(8):2882. doi: PMID 32331298
• Alonso R, Pisa D, Marina AI, Morato E, Rabano A, Rodal I, Carrasco L. Evidence for fungal infection in cerebrospinal fluid and brain tissue from patients with amyotrophic lateral sclerosis. Int J Biol Sci. 2015 Apr 2;11(5):546-58. doi: 10.7150/ijbs.11084. eCollection 2015. PMID 25892962
• Fiore M, Parisio R, Filippini T, Mantione V, Platania A, Odone A, Signorelli C, Pietrini V, Mandrioli J, Teggi S, Costanzini S, Antonio C, Zuccarello P, Oliveri Conti G, Nicoletti A, Zappia M, Vinceti M, Ferrante M. Living near waterbodies as a proxy of cyanobacteria exposure and risk of amyotrophic lateral sclerosis: a population based case-control study. Environ Res. 2020 Jul;186:109530. doi: 10 PMID 32335431
• Sales de Campos P, Olsen WL, Wymer JP, Smith BK. Respiratory therapies for Amyotrophic Lateral Sclerosis: A state of the art review. Chron Respir Dis. 2023 Jan-Dec;20:14799731231175915. doi: 10.1177/14799731231175915. PMID 37219417
• Li JY, Sun XH, Cai ZY, Shen DC, Yang XZ, Liu MS, Cui LY. Correlation of weight and body composition with disease progression rate in patients with amyotrophic lateral sclerosis. Sci Rep. 2022 Aug 2;12(1):13292. doi: 10.1038/s41598-022-16229-9. PMID 35918363
• Bond L, Ganguly P, Khamankar N, Mallet N, Bowen G, Green B, Mitchell CS. A Comprehensive Examination of Percutaneous Endoscopic Gastrostomy and Its Association with Amyotrophic Lateral Sclerosis Patient Outcomes. Brain Sci. 2019 Sep 4;9(9):223. doi: 10.3390/brainsci9090223. PMID 31487846

Identifiers

NCT: NCT07233148 · 25-12-299-2201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗