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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
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple sclerosis.
Select...
I have had a single episode of neurological symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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)
+1 moreSecondary study objectives
Brief Pain Inventory
FM Disease activity (FIQR)
Fibromyalgia Impact Questionnaire Revised
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Terry L. WahlsLead Sponsor
5 Previous Clinical Trials
321 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
321 Patients Enrolled for Multiple Sclerosis
Terry L Wahls, MDPrincipal InvestigatorUniversity of Iowa
4 Previous Clinical Trials
221 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
221 Patients Enrolled for Multiple Sclerosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor has diagnosed me with fibromyalgia.I have been diagnosed with multiple sclerosis.I have had a single episode of neurological symptoms.I have long COVID with fatigue and mental health symptoms for over 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Autoimmune Intervention Mastery Course (AIM) online course
- Group 2: Delayed Autoimmune Intervention Mastery Course
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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