Healing ALS Registry Observational Study (HAROS)

Healing Advocates Registry and Ministry

Status: Enrolling

Conditions: Primary Lateral Sclerosis (PLS); Motor Neuron Disease (MND); Amyotrophic Lateral Sclerosis (ALS)

Treatments: Drug: ALS medications and other medications; Other: Diet, various diets will be observed; Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.; Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.; Other: Physical and emotional support; Other: Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies; Other: Education about treatment options

Study type: Observational

Funder types: Other

Identifiers

NCT07233148

25-12-299-2201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with ALS, MND or PLS

Exclusion criteria

• Smokers

Trial design

1,000 participants in 4 patient groups

ALS/MND less than 3 years since diagnosis

Description:

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.

Treatment:

Other: Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies

Other: Education about treatment options

Other: Physical and emotional support

Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.

Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.

Other: Diet, various diets will be observed

Drug: ALS medications and other medications

PLS less than 3 years since diagnosis

Description:

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.

Treatment:

Other: Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies

Other: Education about treatment options

Other: Physical and emotional support

Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.

Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.

Other: Diet, various diets will be observed

Drug: ALS medications and other medications

ALS/MND 3 years or greater since diagnosis

Description:

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.

Treatment:

Other: Education about treatment options

Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.

Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.

PLS 3 years or greater since diagnosis.

Description:

Those diagnosed with PLS, Primary Lateral Sclerosis and time since diagnosis is 3 years or greater as of the date they join the study.

Treatment:

Other: Education about treatment options

Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.

Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.