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.
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
1,000
Education about treatment options and integrative therapies is optional. It is available online and is free for all study participants.
The investigators are observing type and quantity of dietary supplements, vitamins, minerals and herbs that ALS/MND/PLS patients take regularly.
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.
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, massage, EMS (electro-muscular stimulation), red light therapy and other physical modalities will be observed and analyzed for effect on outcomes.
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.
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.
Virtual
Park City, Utah, United States
RECRUITINGALSFRS-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.
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
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.
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
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.
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.
Weight
Body Weight is often an issue with ALS/MND/PLS patients. The investigators will observe any correlation between body weight and outcomes.
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
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
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
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
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
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. 1. Serum Ferritin measured in ng/ml 2. oxLDL (oxidized LDL) measured in ng/ml 3. Serum 8-OHdG (8-hydroxy-2-deoxyguanosine) measured in ng/ml
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
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
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
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. 1. RBC magnesium (mg/dL) 2. Ceruloplasmin (mg/dL)
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
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)
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
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. 1. Arachidonic Acid (µg/mL) 2. Alpha-Linolenic Acid (µg/mL) 3. Linoleic Acid (µg/mL) 4. DGLA (Dihomo-gamma-linolenic acid) (μg/mL) 5. EPA (Eicosapentaenoic acid) μg/mL 6. DHA (Docosahexaenoic acid) μg/mL
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
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. 1. Methylmalonic acid (μmol/L) 2. Serum Homocysteine (μmol/L)
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
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. 1. Vitamin A Retinol (μg/dL) 2. Serum Copper (μg/dL) 3. Serum Zinc (μg/dL)
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
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. 1. Insulin, fasting (mg/dL) (higher indicates higher level of insulin resistance) 2. Blood Glucose, fasting (mg/dL) (higher indicates higher level of insulin resistance) 3. Triglycerides (mg/dL) (higher indicates higher level of insulin resistance)
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
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)
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 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)
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 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)
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 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. 1. IgG to Epstein Barr Viral Capsid Antigen (U/mL)) 2. IgG to Epstein Barr Nuclear Antigen (U/mL)
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 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. 1. IgG to HHV-6 Viral Antigen (Human Herpes Virus type 6) (titer) 2. IgG to Coxsackie B virus Antigen (titer) 3. Poliovirus Type 1 Antibodies (titer) 4. Poliovirus Type 3 Anitbodies (titer)
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 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. 1. WBC (White Blood Cells) (k/uL) 2. Neutrophils (k/uL) cells per microliter in thousands 3. Lymphocytes (k/uL) cells per microliter in thousands 4. CD57 (k/uL) cells per microliter in thousands
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 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)
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 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)
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 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. 1. Urine aflatoxin (ppb) 2. Urine gliotoxin (ppb) 3. Urine trichothecene (ppb)
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 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. 1. Urine mercury (µg/L) 2. Urine lead (µg/L)
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 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. 1. NfL plasma (Neurofilament Light chain - plasma) pg/mL 2. NfL serum (Neurofilament Light chain - serum) pg/mL
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.
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