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Autoimmune Intervention Mastery Course for Multiple Sclerosis (AIM Trial)

N/A

Recruiting

Led By Terry L Wahls, MD

Research Sponsored by Terry L. Wahls

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported multiple sclerosis

Self-reported clinically isolated syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6months

Awards & highlights

AIM Trial Summary

This trial will test whether an online program can help improve diet and self-care in patients with MS or CIS.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves an educational course rather than medication, traditional side effects are not expected. However, participants may experience stress or discomfort from lifestyle changes.

AIM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with multiple sclerosis.

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I have had a single episode of neurological symptoms.

AIM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)

Short form 36 (SF 36)

Secondary outcome measures

Brief Pain Inventory

FM Disease activity (FIQR)

Fibromyalgia Impact Questionnaire Revised

+7 more

AIM Trial Design

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Terry L. WahlsLead Sponsor

5 Previous Clinical Trials

315 Total Patients Enrolled

4 Trials studying Multiple Sclerosis

315 Patients Enrolled for Multiple Sclerosis

Terry L Wahls, MDPrincipal InvestigatorUniversity of Iowa

4 Previous Clinical Trials

215 Total Patients Enrolled

3 Trials studying Multiple Sclerosis

215 Patients Enrolled for Multiple Sclerosis

Media Library

Delayed Autoimmune Intervention Mastery Course Clinical Trial Eligibility Overview. Trial Name: NCT05057676 — N/A

Multiple Sclerosis Research Study Groups: Intervention Autoimmune Intervention Mastery Course (AIM) online course, Delayed Autoimmune Intervention Mastery Course

Multiple Sclerosis Clinical Trial 2023: Delayed Autoimmune Intervention Mastery Course Highlights & Side Effects. Trial Name: NCT05057676 — N/A

Delayed Autoimmune Intervention Mastery Course 2023 Treatment Timeline for Medical Study. Trial Name: NCT05057676 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for volunteers in this experiment?

"Clinicaltrials.gov shows that, despite initiating recruitment on December 1st 2021 and having a most recent update recorded on July 3rd 2022, this particular medical study is not presently accepting patients. Nonetheless, 553 other trials are currently recruiting participants for their studies."

Answered by AI

What are the chief aims of this investigation?

"This trial, which will be monitored from the outset to 6 months post-treatment, aims to improve Multiple sclerosis 54 Quality of Life Mental health scores (MS 54 QoL MH). Secondary objectives include Modified Fatigue Impact Scale responses (MFIS survey), added sugar intake in grams per day, and calcium consumption between 0 to 2000 milligrams."

Answered by AI

What patient criteria is required for participation in this medical research?

"Potential candidates for this clinical trial must have a diagnosis of multiple sclerosis and fit within the parameters of 18 to 100 years old. Approximately 80 participants are being accepted into the study."

Answered by AI

Does this trial extend eligibility to those under 30 years of age?

"The criteria for taking part in this medical trial necessitates potential participants to fall between 18 and 100 years of age. Moreover, there are 44 studies available for young people under the age of eighteen, while those aged 65 or older can choose from 394 separate clinical trials."

Answered by AI

Recent research and studies

TrialsJournal

Dietary Approaches to Treat Ms-related Fatigue: Comparing the Modified Paleolithic (wahls Elimination) and Low Saturated Fat (swank) Diets on Perceived Fatigue in Persons with Relapsing-remitting Multiple Sclerosis: Study Protocol for a Randomized Controlled Trial

Wahls, Terry, Maria O. Scott, Zaidoon Alshare, Linda Rubenstein, Warren Darling, Lucas Carr, Karen Smith, Catherine A. Chenard, Nicholas LaRocca, and Linda Snetselaar. 2018. “Dietary Approaches to Treat Ms-related Fatigue: Comparing the Modified Paleolithic (wahls Elimination) and Low Saturated Fat (swank) Diets on Perceived Fatigue in Persons with Relapsing-remitting Multiple Sclerosis: Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-018-2680-x.

NutrientsJournal

Eating Pattern and Nutritional Risks Among People with Multiple Sclerosis Following a Modified Paleolithic Diet

Titcomb, Tyler J., Babita Bisht, David D. Moore III, Yashpal S. Chhonker, Daryl J. Murry, Linda G. Snetselaar, and Terry L. Wahls. 2020. “Eating Pattern and Nutritional Risks Among People with Multiple Sclerosis Following a Modified Paleolithic Diet”. Nutrients. MDPI AG. doi:10.3390/nu12061844.

Multiple Sclerosis Journal - Experimental, Translational and ClinicalJournal

Impact of the Swank and Wahls Elimination Dietary Interventions on Fatigue and Quality of Life in Relapsing-remitting Multiple Sclerosis: The WAVES Randomized Parallel-arm Clinical Trial

Wahls, Terry L, Tyler J Titcomb, Babita Bisht, Patrick Ten Eyck, Linda M Rubenstein, Lucas J Carr, Warren G Darling, Karin F Hoth, John Kamholz, and Linda G Snetselaar. 2021. “Impact of the Swank and Wahls Elimination Dietary Interventions on Fatigue and Quality of Life in Relapsing-remitting Multiple Sclerosis: The WAVES Randomized Parallel-arm Clinical Trial”. Multiple Sclerosis Journal - Experimental, Translational and Clinical. SAGE Publications. doi:10.1177/20552173211035399.

Journal of the American College of NutritionJournal