Healing ALS Registry Observational Study (HAROS) (HAROS)

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis (ALS); Primary Lateral Sclerosis (PLS); Motor Neuron Disease (MND)
• Intervention / Treatment: Other: Education about treatment options; Dietary supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.; Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.; Other: Diet, various diets will be observed; Other: Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies; Drug: ALS medications and other medications; Other: Physical and emotional support

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Healing ALS Study Administrator; Phone Number: 1-973-714-4621; Email: study@healingals.org

Study Locations

• United States
  • Utah
    • Park City, Utah, United States, 84098
      • Recruiting
      • Virtual
      • Contact: Healing ALS Study Administrator; Phone Number: 1-973-714-4621; Email: study@healingals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The investigators are studying adult non-smokers who have a diagnosis of ALS, MND or PLS, irrespective of time since diagnosis.

Description

Inclusion Criteria:

• Diagnosed with ALS, MND or PLS

Exclusion Criteria:

• Smokers

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ALS/MND less than 3 years since diagnosis; Those diagnosed with ALS, Amyotrophic Lateral Sclerosis or MND, Motor Neuron Disease (other countries) and time since diagnosis is less 3 years, or 36 months, as of the date they join the study.	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.
PLS less than 3 years since diagnosis; Those diagnosed with PLS, Primary Lateral Sclerosis, and time since diagnosis is less 3 years, or 36 months, as of the date they join the study.	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.
ALS/MND 3 years or greater since diagnosis; Those diagnosed with ALS, Amyotrophic Lateral Sclerosis or MND, Motor Neuron Disease (other countries) and time since diagnosis is 3 years or greater as of the date they join the study.	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.
PLS 3 years or greater since diagnosis.; Those diagnosed with PLS, Primary Lateral Sclerosis and time since diagnosis is 3 years or greater as of the date they join the study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALSFRS-R ALS Functional Rating Scale - Revised	ALS Functional Ratings Scale is a set of 12 questions, with a maximum of 4 points per question and measures physical functionality. Outcomes are measured at a point in time and range from 0 for no functionality to 48 for full functionality in all areas measured. The higher the score the better the outcome.	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	ALS Supplementary Questionnaire (ALSSQ) is a measure of physical functionality and symptoms that are not measured in the ALSFRS-R scale. Items measured in the ALSSQ are energy level, sleep quality and quantity, pain, fasciculations, muscle cramps, mucous, mental clarity, head drop and showing emotions inappropriately. There are 18 questions, 4 points each, for a maximum of 72 points. The higher this score, the better the outcome.	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	Mindset is measured by questions about A) positivity, maximum 400 points, B) belief in ability to get well and mental blocks to healing, maximum 18 points, and C) a Modified PANAS (Positive and Negative Affect Schedule), maximum of 50 positive points and 50 negative points. The investigators will analyze how these measures of mindset correlate with ALS/MND/PLS outcomes.	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

Outcome Measure	Measure Description	Time Frame
Weight	Body Weight is often an issue with ALS/MND/PLS patients. The investigators will observe any correlation between body weight and outcomes.	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	All lab tests are optional, and ordered through the patient's physician and recorded. Inflammation and neuroinflammation are often associated with ALS/MND/PLS. Higher inflammatory markers may be correlated with faster disease progression. The investigators will analyze how these measures correlate with ALS/MND/PLS outcomes. NfL plasma (Neurofilament Light chain - plasma) pg/mL NfL serum (Neurofilament Light chain - serum) pg/mL Interleukin-6 pg/ml TMAO (Trimethylamine-N-Oxide) pg/mL	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	All lab tests are optional, and ordered through the patient's physician and recorded. Inflammation and neuroinflammation are often associated with ALS/MND/PLS. Higher inflammatory markers may be correlated with faster disease progression. The investigators will analyze how these measures correlate with ALS/MND/PLS outcomes. hs-CRP (high sensitivity C-Reactive Protein) mg/dL GGT (gamma-glutamyl transferase) mg/dL	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	All lab tests are optional, and ordered through the patient's physician. Higher oxidative stress may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.; Serum Ferritin measured in ng/ml; oxLDL (oxidized LDL) measured in ng/ml; Serum 8-OHdG (8-hydroxy-2-deoxyguanosine) measured in ng/ml	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	All lab tests are optional, and ordered through the patient's physician. Higher oxidative stress may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. a. Serum malondialdehyde measured in nmol/mL	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	All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.; RBC magnesium (mg/dL); Ceruloplasmin (mg/dL)	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	All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. a. Vitamin D-25 Hydroxy (ng/mL)	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	All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.; Arachidonic Acid (µg/mL); Alpha-Linolenic Acid (µg/mL); Linoleic Acid (µg/mL); DGLA (Dihomo-gamma-linolenic acid) (μg/mL); EPA (Eicosapentaenoic acid) μg/mL; DHA (Docosahexaenoic acid) μg/mL	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	All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.; Methylmalonic acid (μmol/L); Serum Homocysteine (μmol/L)	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	All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.; Vitamin A Retinol (μg/dL); Serum Copper (μg/dL); Serum Zinc (μg/dL)	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	All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.; Insulin, fasting (mg/dL) (higher indicates higher level of insulin resistance); Blood Glucose, fasting (mg/dL) (higher indicates higher level of insulin resistance); Triglycerides (mg/dL) (higher indicates higher level of insulin resistance)	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	All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. a. HDL Cholesterol (mg/dL) (lower indicates higher level of insulin resistance)	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 3	All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. a. Fructosamine, fasting (µmol/L) (higher indicates higher level of insulin resistance)	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 4	All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. a. Hemoglobin A1C (percent) (higher indicates higher level of insulin resistance)	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 infection markers Set 1	All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher IgG indicates a higher level of infection.; IgG to Epstein Barr Viral Capsid Antigen (U/mL)); IgG to Epstein Barr Nuclear Antigen (U/mL)	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 infection markers Set 2	All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher titer indicates a higher level of infection.; IgG to HHV-6 Viral Antigen (Human Herpes Virus type 6) (titer); IgG to Coxsackie B virus Antigen (titer); Poliovirus Type 1 Antibodies (titer); Poliovirus Type 3 Anitbodies (titer)	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 infection markers Set 3	All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate withALS/MND/PLS outcomes. The higher the marker, the higher the level of infection.; WBC (White Blood Cells) (k/uL); Neutrophils (k/uL) cells per microliter in thousands; Lymphocytes (k/uL) cells per microliter in thousands; CD57 (k/uL) cells per microliter in thousands	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 infection markers Set 4	All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher C4A can indicate a higher level of infection, inflammation or autoimmune conditions. a. C4A (Complement 4A) (mg/dL)	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 infection markers Set 5	All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher LPS can indicate bacteria from the gut entering the bloodstream because of increased intestinal permeability. a. LPS Lipopolysaccharides by Endotoxin Activity Assay (EU - Endotoxin Units)	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 urine toxin markers Set 1	All lab tests are optional, and ordered through the patient's physician. Increased levels of urine toxins may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.; Urine aflatoxin (ppb); Urine gliotoxin (ppb); Urine trichothecene (ppb)	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 urine toxin markers Set 2	All lab tests are optional, and ordered through the patient's physician. Increased levels of urine toxins may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.; Urine mercury (µg/L); Urine lead (µg/L)	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 NfL (Neurofilament Light chain)	All lab tests are optional, and ordered through the patient's physician and recorded. NfL (lNeurofilament Light chain) can be used to assess neuronal damage with ALS/MND/PLS. A higher level of NfL often indicates a higher level of neuronal damage. The investigators will analyze how changes in NfL correlate with ALS/MND/PLS outcomes.; NfL plasma (Neurofilament Light chain - plasma) pg/mL; NfL serum (Neurofilament Light chain - serum) pg/mL	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.

Collaborators and Investigators

• Sponsor: Healing Advocates Registry and Ministry
• Investigators: Principal Investigator: William L Cowden, MD, Chair of Scientific Board of Academy of Comprehensive Integrative Medicine, Co-chair of Medical Advisory Team of Healing ALS

Publications and helpful links

General Publications

• Harrison D, Mehta P, van Es MA, Stommel E, Drory VE, Nefussy B, van den Berg LH, Crayle J, Bedlack R; Pooled Resource Open-Access ALS Clinical Trials Consortium. "ALS reversals": demographics, disease characteristics, treatments, and co-morbidities. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Nov;19(7-8):495-499. doi: 10.1080/21678421.2018.1457059. Epub 2018 Apr 2.
• 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.
• Shochey C. Perimenopause and heavy menstrual flow: standard treatments and alternative treatment modalities. Nurse Pract. 1994 Sep;19(9):73-5. No abstract available.
• Brown GC. Rate control within the Na+/glucose cotransporter. Biophys Chem. 1995 Apr;54(2):181-9. doi: 10.1016/0301-4622(94)00132-4.
• Ruppert PH, Clemens LG. The role of aromatization in the development of sexual behavior of the female hamster (Mesocricetus auratus). Horm Behav. 1981 Mar;15(1):68-76. doi: 10.1016/0018-506x(81)90035-0. No abstract available.
• Arntzen CJ, Dilley RA, Peters GA, Shaw ER. Photochemical activity and structural studies of photosystems derived from chloroplast grana and stroma lamellae. Biochim Biophys Acta. 1972 Jan 21;256(1):85-107. doi: 10.1016/0005-2728(72)90165-x. No abstract available.
• 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: 10.1016/j.envres.2020.109530. Epub 2020 Apr 15.
• 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.
• 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.
• Floeter MK, Mills R. Progression in primary lateral sclerosis: a prospective analysis. Amyotroph Lateral Scler. 2009 Oct-Dec;10(5-6):339-46. doi: 10.3109/17482960903171136.
• Syrow L, Calderwood D, Newton C; An Integrative Medicine approach may slow disease in ALS patients compared to standard of care: A pilot observational study. Annals of Neurology Volume 96, Number S32, 149th Annual Meeting American Neurological Association pp. S278-279 (September 2024) https://onlinelibrary.wiley.com/doi/10.1002/ana.27051
• Crayle J, Lutz M, Raymond J, Mehta P, Bedlack R. Study of "ALS reversals": LifeTime environmental exposures (StARLiTE). Amyotroph Lateral Scler Frontotemporal Degener. 2023 Feb;24(1-2):54-62. doi: 10.1080/21678421.2022.2090846. Epub 2022 Jul 1.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): February 5, 2036
• Study Completion (Estimated): March 31, 2036

Study Registration Dates

• First Submitted: August 7, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Amyotrophic Lateral Sclerosis; ALS; Motor Neuron Disease; Motor Neurone Disease; MND; Primary Lateral Sclerosis; PLS
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Nutritional and Metabolic Diseases; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Inorganic Chemicals; Patient Care; Behavior Therapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Hyperthermia, Induced; Behavior Control; Immobilization; Rehabilitation of Speech and Language Disorders; Therapy, Soft Tissue; Musculoskeletal Manipulations; Relaxation Therapy; Balneology; Exercise; Diet; Restraint, Physical; Speech Therapy; Occupational Therapy; Psychotherapy; Physical Therapy Modalities; Massage; Meditation; Steam Bath; Minerals
• Other Study ID Numbers: 25-12-299-2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the published article, after de-identification (text, tables, figures and appendices)
• IPD Sharing Time Frame: The investigators will share IPD starting 1 year after publication and will make it available for 3 years from that date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal as assessed by our Scientific Advisory Team.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No