Autoimmune Intervention Mastery Course for Multiple Sclerosis (AIM Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Terry L. Wahls
No Placebo Group
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.
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.
13467What 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.
258910Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
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
I have been diagnosed with multiple sclerosis.
I have had a single episode of neurological symptoms.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Intervention Autoimmune Intervention Mastery Course (AIM) online courseExperimental Treatment2 Interventions
This arm will begin the intervention immediately after randomization
Group II: Delayed Autoimmune Intervention Mastery CourseExperimental Treatment2 Interventions
This is the control arm.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Univeristy of IowaIowa City, IA
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Who is running the clinical trial?
Terry L. WahlsLead Sponsor
References
Therapy of autoimmune diseases: clinical trials and new biologics. [2019]Successful clinical efficacy trials have been recently completed for a growing array of new biologics. Prospects are improving for rational therapeutic interventions that potently interrupt adaptive immune response pathways. By contrast, disappointing results with antigen-based therapeutics highlight the difficulties of achieving tolerance in the context of active autoimmunity. Combination immunotherapy is probably necessary to sequentially or simultaneously inhibit inflammation, uncouple innate immune pathways, interrupt or ablate the adaptive memory response and promote antigen-specific tolerance in a suitable immunological context.
A randomised controlled trial of lay-led self-management for people with multiple sclerosis. [2022]To determine the impact of the Chronic Disease Self-Management Course (CDSMC) on people with multiple sclerosis (MS).
Modern therapeutic strategies for autoimmune diseases. [2019]Autoimmunity is an overreaction of immune competent cells to self structures resulting in an unwanted clinical outcome. Traditional therapeutic strategies, still relevant in many cases, involve broad acting immunosuppressants such as cyclophosphamide with the predictable attendant toxicity. More recent concepts include blockade of specifically defined targets such as TNF-α, with resulting immunomodulation and less toxicity. Both of these strategies require ongoing drug treatment of established disease. A long standing goal, not yet achieved, is the predictable induction of tolerance, obviating the need for chronic treatment. Experimental strategies to achieve this include pre-emptive (preclinical) treatment before chronification is established, total immune ablation and immune "resetting" and autoantigen immunisation.
Current and future immunotherapy targets in autoimmune neurology. [2017]Randomized controlled treatment trials of autoimmune neurologic disorders are generally lacking and data pertaining to treatment are mostly derived from expert opinion, large case series, and anecdotal reports. The treatment of autoimmune neurologic disorders comprises oncologic therapy (where appropriate) and immunotherapy. In this chapter, we first describe the standard acute and chronic immunotherapies and provide a practical overview of their use in the clinic (mechanisms of action, dosing, monitoring, and side effects). Novel approaches to treatment of autoimmune neurologic disorders, through new drug discovery or repurposing, are dependent on improved mechanistic understanding of immunopathology. Such approaches, with emphasis on monoclonal antibodies, are discussed using the paradigm of three autoimmune neurologic disorders whose immunopathogenesis is better understood, specifically myasthenia gravis, neuromyelitis optica, and chronic inflammatory demyelinating polyradiculoneuropathy. It is important to realize that the treatment strategy and management plan must be individualized for each patient. In general these are influenced by the following: clinical severity, antibody type, presence or absence of cancer, and prior treatment response, if known.
Enhancing the quality of care for patients with multiple sclerosis through performance improvement CME. [2020]Multiple sclerosis (MS) is an inflammatory neurodegenerative disease marked by a heterogeneous clinical presentation and disease course. Although improvements in the recognition and management of MS have been made in recent years, challenges remain due to the complex nature of the disease. Clinicians must remain current with their skills as knowledge surrounding MS care continues to advance. Here we report results of a performance improvement (PI) continuing medical education (CME) activity that was designed to promote evidence-based care of patients with MS. Participants demonstrated significant improvements in assessing disease-related complications, treating cognitive dysfunction, assessing adherence, and providing disease-related educational materials. These data support the role of PI CME in improving clinician practices that align with quality MS patient care.
Challenges, Progress, and Prospects of Developing Therapies to Treat Autoimmune Diseases. [2022]Autoimmune diseases are a result of the immune system being misdirected toward its host and have major and increasing unmet clinical needs. In general, present therapies are broadly acting and non-disease specific; consequently, they are associated with numerous side effects. Precise and early intervention strategies are urgently needed. We highlight the challenges, progress, and prospects in achieving these goals.
Immunotherapy of Autoimmune Disease. [2021]Selective immunointervention in autoimmune diseases can essentially be directed to three cellular targets: antigen-presenting cells expressing HMC class II molecules autoreactive T cells and regulatory T cells able to influence the pathogenic T cells. Immunotherapy in experimental models of autoimmune diseases has demonstrated that disease can be prevented or treated by intervening on each cellular target. MHC class II-binding peptides can be effective and selective inhibitors of T cell activation in vivo, and several immunoregulatory mechanisms may be responsible for their interference with the activation of antigen-specific T cells. Discerning the precise mode of action of class II-binding peptides may eventually permit rational and selective immunointervention in human autoimmune diseases.
Consensus Curriculum for Fellowship Training in Multiple Sclerosis and Neuroimmunology. [2022]Management of multiple sclerosis and neuroimmunologic disorders has become increasingly complex because of the expanding number of recognized neuroimmune disorders, increased number of therapeutic options, and multidisciplinary care management needs of people with multiple sclerosis and neuroimmunologic disorders. More subspecialists are needed to optimize care of these patients, and many fellowship programs have been created or expanded to increase the subspecialty workforce. Consequently, defining the scope and standardizing fellowship training is essential to ensure that trainees receive high-quality training. A workgroup was created to develop a consensus fellowship curriculum to serve as a resource for all current and future training programs. This curriculum may also serve as a basis for future accreditation efforts.
Self-management interventions for people with multiple sclerosis: A systematic review and meta-analysis protocol. [2023]Educational self-management interventions (SMI) have an important role in improving symptom management, preventing relapse of multiple sclerosis (MS) and promoting quality of life (QoL) of these patients; since there is little knowledge about overall effectiveness of MS self-management programs and which types of SMI improves the outcomes, this research aims to assess the efficacy of structured SMI in improving health outcomes in people with MS (PwMS) by synthesizing and compare outcomes from related randomized controlled trials.
The impact of therapeutic education programs on the quality of life of patients with multiple sclerosis: Protocol of a systematic review. [2023]The quality of life (QOL) of patients with multiple sclerosis (MS) is estimated to be poor compared to the general population. Its management is complex thus requiring openness to non-pharmacological approaches such as therapeutic education (TPE). However, there is an abundance of educational programs with several components and varying degrees of effectiveness. This protocol is developed with the objective to determine the impact of TPE programs on the QOL of MS patients. We will undergo research in PubMed, Web of Science, and Scopus to identify all eligible articles published between January 1st, 2007, and February 2022 evaluating the QOL. We will include any quantitative study design: Randomized Controlled Trials (RCTs), non-randomized controlled trials, non-randomized uncontrolled trials, and observational studies. The quality of these studies will be assessed by recommended tools. Two investigators will independently perform the data extractions and any disagreements will be resolved by other reviewers. A narrative synthesis will report results according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist guidelines to draw conclusions based on the totality of the evidence. These results will be summarized by characteristics of studies and programs and by effects on the QOL. This systematic review will provide practice guidance and evidence to effectively target the features and components of TPE programs, to effectively meet the specific needs of MS patients and thereby improve their QOL, and on the other hand to facilitate the appropriation of these programs by clinicians and researchers to optimize the management of MS. Systematic review registration: PROSPERO CRD42022338651.