Autoimmune Intervention Mastery Course for Multiple Sclerosis

(AIM Trial)

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Terry L. Wahls

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

Compensation: Varies

Number of Visits: 5

Duration: 7 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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 sclerosis (MS), clinically isolated syndrome (CIS), fibromyalgia, post acute sequela of covid, and cancer in remission with persisting fatigue.

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 data supports the effectiveness of the treatment Autoimmune Intervention Mastery Course for Multiple Sclerosis?

Research suggests that educational self-management interventions and therapeutic education programs can improve symptom management and quality of life for people with multiple sclerosis, indicating that similar educational approaches like the Autoimmune Intervention Mastery Course may also be beneficial. ^{1 2 3 4 5}

How is the Autoimmune Intervention Mastery Course treatment for Multiple Sclerosis different from other treatments?

The Autoimmune Intervention Mastery Course treatment is unique because it aims to induce immune tolerance, potentially reducing the need for ongoing medication. This approach contrasts with traditional treatments that often require continuous use of broad immunosuppressants, which can have significant side effects. ^{6 7 8 9 10}

Research Team

Terry L Wahls, MD, MBA

Principal Investigator

University of Iowa

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Enhancing the quality of care for patients with multiple sclerosis through performance improvement CME. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Self-management interventions for people with multiple sclerosis: A systematic review and meta-analysis protocol. [2023]

3. India 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Consensus Curriculum for Fellowship Training in Multiple Sclerosis and Neuroimmunology. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of lay-led self-management for people with multiple sclerosis. [2022]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Modern therapeutic strategies for autoimmune diseases. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Immunotherapy of Autoimmune Disease. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Current and future immunotherapy targets in autoimmune neurology. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Challenges, Progress, and Prospects of Developing Therapies to Treat Autoimmune Diseases. [2022]

10. England pubmed.ncbi.nlm.nih.gov

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