Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2026-01-26
2036-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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 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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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 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.
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.
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 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.
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.
Interventions
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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 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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
110 Years
ALL
No
Sponsors
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Healing Advocates Registry and Ministry
OTHER
Responsible Party
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William Lee Cowden
Principal Investigator
Principal Investigators
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William L Cowden, MD
Role: PRINCIPAL_INVESTIGATOR
Chair of Scientific Board of Academy of Comprehensive Integrative Medicine, Co-chair of Medical Advisory Team of Healing ALS
Locations
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Virtual
Park City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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
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.
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.
Other Identifiers
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25-12-299-2201
Identifier Type: -
Identifier Source: org_study_id
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