Health TrialsbyHealthPanel

Healing ALS Registry Observational Study (HAROS)

ConditionsAmyotrophic Lateral Sclerosis (ALS)Motor Neuron Disease (MND)Primary Lateral Sclerosis (PLS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorHealing Advocates Registry and Ministry

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with ALS, MND or PLS

Disqualifiers

Smokers

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Education about treatment options

    Other intervention

    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.

    Dietary supplement

    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.

    Behavioral

    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

    Other intervention

    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

    Other intervention

    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

    Drug

    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

    Other intervention

    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.

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: ALS/MND less than 3 years since diagnosis7 interventions
Group B: PLS less than 3 years since diagnosis7 interventions
Group C: ALS/MND 3 years or greater since diagnosis3 interventions
Group D: PLS 3 years or greater since diagnosis.3 interventions

Trial outcomes

Primary outcomes

1

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.

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.
2

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.
3

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Healing Advocates Registry and Ministry

Lead sponsor

Source ClinicalTrials.gov
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