Autoimmune Intervention Mastery Course for Multiple Sclerosis

(AIM Trial)

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Terry L. Wahls

Disqualifiers: Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 7 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online course designed to help individuals with certain autoimmune conditions improve their diet and self-care. The researchers aim to determine if this program can enhance the quality of life for those with multiple sclerosis (MS), clinically isolated syndrome (a precursor to MS), fibromyalgia, long COVID, or cancer-related fatigue. Participants will either begin the Immediate Autoimmune Intervention Mastery Course immediately or after a short delay with the Delayed Autoimmune Intervention Mastery Course. Suitable candidates for the trial include those with self-reported MS, clinically isolated syndrome, long COVID with ongoing fatigue and mental challenges, or fibromyalgia confirmed by a doctor. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve the quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this online program is safe for patients with multiple sclerosis and related conditions?

Research has shown that the Autoimmune Intervention Mastery (AIM) Course helps people improve their diet and self-care through an online program. It involves no drugs or medical procedures, focusing instead on lifestyle changes to support the immune system.

As an online course rather than a medication, it carries low risks. No reports of negative effects have emerged from this program, which primarily involves learning new habits and ways to manage health.

The AIM course is safe for most people, teaching management of autoimmune issues without medication. Although this approach is new, it has been well-received so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Autoimmune Intervention Mastery Course for multiple sclerosis because it offers a novel approach to managing the condition through an online educational platform. Unlike traditional treatments like disease-modifying therapies, which often involve medication to slow the disease progression, this course focuses on empowering patients with knowledge and skills to manage their symptoms and improve their quality of life. The immediate intervention arm of the course allows participants to start learning and applying these techniques right away, which could lead to faster improvements in self-management. This innovative method highlights the potential benefits of non-pharmacological strategies in chronic disease management, offering a complementary approach to existing medical therapies.

What evidence suggests that this trial's treatments could be effective for multiple sclerosis?

Research has shown that better diet and self-care can alleviate symptoms of conditions like multiple sclerosis (MS). In this trial, participants will enroll in the Autoimmune Intervention Mastery Course, an online program aimed at improving these areas. The trial includes two arms: one where participants start the course immediately and another where the course is delayed. Studies have found that lifestyle changes, such as healthier eating, can enhance health for people with autoimmune conditions. Although specific data on this course's impact on MS is limited, similar programs have proven beneficial. Early results suggest that participants might experience improvements in managing fatigue and other ongoing symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Terry L Wahls, MD, MBA

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like multiple sclerosis, clinically isolated syndrome, fibromyalgia, or long-lasting symptoms after COVID-19. Participants must have a self-reported diagnosis and persistent fatigue or neuropsychiatric symptoms for over 6 months post-COVID.

Inclusion Criteria

My doctor has diagnosed me with fibromyalgia.

I have been diagnosed with multiple sclerosis.

I have had a single episode of neurological symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 virtual visit

Baseline Assessment

Participants complete baseline assessments and are randomized to intervention or control arm

1 week

1 virtual visit

Treatment

Participants receive access to the online course and group support videos over 7 weeks

7 weeks

Weekly virtual access to course materials

Follow-up

Participants are monitored for quality of life and fatigue outcomes

6 months

3 virtual visits (months 0, 3, and 6)

What Are the Treatments Tested in This Trial?

Interventions

• Delayed Autoimmune Intervention Mastery Course
• Immediate Autoimmune Intervention Mastery Course

Trial Overview The study tests an online program called Autoimmune Intervention Mastery Course (AIM), which focuses on diet and self-care improvements. It compares immediate access to AIM with delayed access to see how effective the program is.

How Is the Trial Designed?

Group I: Intervention Autoimmune Intervention Mastery Course (AIM) online course Experimental Treatment 2 Interventions

This arm will begin the intervention immediately after randomization

Group II: Delayed Autoimmune Intervention Mastery Course Experimental Treatment 2 Interventions

This is the control arm.

Who Is Running the Clinical Trial?

Terry L. Wahls

Lead Sponsor

Trials

6

Recruited

400+

Published Research Related to This Trial

A performance improvement continuing medical education (CME) program for clinicians significantly enhanced their skills in managing multiple sclerosis (MS), particularly in assessing complications and treating cognitive dysfunction.

The study highlights the importance of ongoing education for healthcare providers, as it leads to better alignment with evidence-based practices in MS patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the quality of care for patients with multiple sclerosis through performance improvement CME. Cohen, BA., Thrower, BW., Berry, CA., et al.[2020]

There is a lack of randomized controlled trials for treating autoimmune neurologic disorders, with most treatment data coming from expert opinions and case series, highlighting the need for more rigorous research in this area.

Current treatment strategies involve both standard immunotherapies and novel approaches, such as monoclonal antibodies, tailored to individual patient needs based on factors like disease severity and previous treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future immunotherapy targets in autoimmune neurology. Hu, MY., Stathopoulos, P., O'connor, KC., et al.[2017]

Autoimmune diseases occur when the immune system mistakenly attacks the body's own tissues, leading to significant clinical challenges and unmet needs for effective treatments.

Current therapies for autoimmune diseases are often non-specific and can cause various side effects, highlighting the urgent need for targeted and early intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges, Progress, and Prospects of Developing Therapies to Treat Autoimmune Diseases. Fugger, L., Jensen, LT., Rossjohn, J.[2022]

This systematic review aims to evaluate the impact of therapeutic education programs on the quality of life (QOL) of multiple sclerosis (MS) patients, addressing the need for effective non-pharmacological management strategies.

By analyzing various study designs from 2007 to 2022, the review will provide evidence-based guidance for clinicians and researchers to optimize TPE programs tailored to the specific needs of MS patients, potentially improving their overall QOL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of therapeutic education programs on the quality of life of patients with multiple sclerosis: Protocol of a systematic review. Raji, I., El Harch, I., Ragala, MEA., et al.[2023]

Selective immunotherapy targeting specific cellular components in autoimmune diseases has shown promise in preventing or treating these conditions, as demonstrated in experimental models.

MHC class II-binding peptides can effectively inhibit T cell activation, suggesting that understanding their mechanisms could lead to more targeted and effective treatments for autoimmune diseases in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of Autoimmune Disease. Adorini, L.[2021]

Recent clinical trials have shown that new biologic therapies can effectively disrupt adaptive immune response pathways, offering promising treatment options for autoimmune conditions.

Antigen-based therapies have struggled to achieve desired outcomes in active autoimmunity, suggesting that combination immunotherapy may be essential to effectively manage inflammation and promote tolerance in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy of autoimmune diseases: clinical trials and new biologics. Nepom, GT.[2019]

This systematic review aims to evaluate the effectiveness of structured self-management interventions (SMI) in improving health outcomes for people with multiple sclerosis (PwMS) by analyzing data from randomized controlled trials published from 2000 to July 2023.

The study will assess various health outcomes, including quality of life, depression, self-efficacy, pain, and fatigue, to identify the most effective components of SMIs, which could lead to better-targeted interventions for specific groups of PwMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management interventions for people with multiple sclerosis: A systematic review and meta-analysis protocol. Heidari-Soureshjani, R., Nasrabadi, AN., Zakerimoghadam, M., et al.[2023]

The Chronic Disease Self-Management Course (CDSMC) significantly improved self-management self-efficacy and physical status in people with multiple sclerosis (MS) after 4 and 12 months, based on a randomized controlled trial with 216 participants.

While the CDSMC showed small positive effects, it may be particularly beneficial for individuals with mild anxiety or depression, suggesting that early attendance in the disease course could enhance support and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of lay-led self-management for people with multiple sclerosis. Barlow, J., Turner, A., Edwards, R., et al.[2022]

Traditional treatments for autoimmunity often involve broad immunosuppressants like cyclophosphamide, which can cause significant toxicity, highlighting the need for safer alternatives.

Newer strategies focus on targeting specific immune pathways, such as TNF-α, to modulate the immune response with reduced side effects, but the ultimate goal remains to induce long-term tolerance without the need for ongoing medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern therapeutic strategies for autoimmune diseases. Tyndall, A.[2019]

The management of multiple sclerosis and neuroimmunologic disorders is becoming more complex due to the growing number of recognized conditions and treatment options, highlighting the need for more specialized care.

A consensus fellowship curriculum has been developed to standardize training for subspecialists, ensuring high-quality education and potentially aiding future accreditation efforts in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus Curriculum for Fellowship Training in Multiple Sclerosis and Neuroimmunology. Hua, LH., Obeidat, AZ., Amezcua, L., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05057676

Autoimmune Intervention Mastery Course Study ... The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients with multiple ...

2. ctv.veeva.com ctv.veeva.com/study/autoimmune-intervention-mastery-course-study

Autoimmune Intervention Mastery Course Study (AIM) The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients ...

3. withpower.com withpower.com/trial/phase-multiple-sclerosis-10-2021-ab9b8

Autoimmune Intervention Mastery Course for Multiple ... The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients with multiple ...

4. clinicaltrial.be clinicaltrial.be/en/details/1286?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Autoimmune Intervention Mastery Course Study - Clinical T... The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients ...

5. terrywahls.com terrywahls.com/aim/

Autoimmune Intervention Mastery Course – Dr. Terry Wahls Our Autoimmune Intervention Mastery Course helps you learn how to confidently overcome your autoimmune dysfunction and AIM to reclaim your health.

6. mscare.org mscare.org/data-show-effects-of-tecfidera-in-newly-diagnosed-and-early-disease-course-multiple-sclerosis-patients/

Data show effects of TECFIDERA in newly-diagnosed and ... The data show that TECFIDERA significantly reduced multiple sclerosis (MS) relapses and delayed disability progression in patients who are newly diagnosed.