Relapsing Remitting Multiple Sclerosis Clinical Trial
Official title:
Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis
Verified date | March 2024 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A key question in efforts to reduce symptoms and improve quality of life for multiple sclerosis (MS) patients is whether a therapeutic lifestyle (diet, stress reduction and exercise) is inferior to disease-modifying drug treatments in terms of reducing multiple sclerosis related symptoms, improving function and quality of life, and reducing the number of acute inflammatory lesions and loss of brain volume. This study will prospectively assess the changes in quality of life and clinical outcomes in two cohorts of patients who are recently diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) to begin answering that question. The goal of this project is to compare a diet and therapeutic lifestyle only treatment usual care in the setting of newly diagnosed individuals with RRMS or CIS, which is the precursor to the development of MS. Due to the COVID 19 Pandemic, the study was redesigned from an in-person study to a virtual visit only study prior to enrolling study subjects.
Status | Active, not recruiting |
Enrollment | 44 |
Est. completion date | September 1, 2027 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - 1) A diagnosis of clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) or CIS according to the 2010 McDonald's criteria, confirmed by the treating neurologist within 12 months of completing the first study visit.2) Must consent to sharing the clinical notes from their primary care and neurology providers during the study period.3) Must reside within the lower 48 states within the United States.4) Agreement by the treating neurologist that the patient may enroll in the study. Exclusion Criteria: 1) Moderate or severe mental impairment as measured by the Short Portable Mental Health Questionnaire. 2) Presence of a contraindication to completing a brain MRI or having claustrophobia which interferes with completion of MRI studies without the use of sedation. 3) Taking insulin or Coumadin® medication. 4) History of oxalate kidney stones, schizophrenia, or active diagnosis of eating disorder. 5) Greater than 12 months since initial diagnosis of RRMS or CIS and first study visit. |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Terry L. Wahls |
United States,
Bisht B, Darling WG, Grossmann RE, Shivapour ET, Lutgendorf SK, Snetselaar LG, Hall MJ, Zimmerman MB, Wahls TL. A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue. J Altern Complement Med. 2014 May;20(5):347-55. doi: 10.1089/acm.2013.0188. Epub 2014 Jan 29. — View Citation
Bisht B, Darling WG, Shivapour ET, Lutgendorf SK, Snetselaar LG, Chenard CA, Wahls TL. Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2015;5:19-35. doi: 10.2147/DNND.S76523. Epub 2015 Feb 27. Erratum In: Degener Neurol Neuromuscul Dis. 2015 Sep 10;5:91. — View Citation
Chenard CA, Rubenstein LM, Snetselaar LG, Wahls TL. Nutrient Composition Comparison between a Modified Paleolithic Diet for Multiple Sclerosis and the Recommended Healthy U.S.-Style Eating Pattern. Nutrients. 2019 Mar 1;11(3):537. doi: 10.3390/nu11030537. — View Citation
Fellows Maxwell K, Wahls T, Browne RW, Rubenstein L, Bisht B, Chenard CA, Snetselaar L, Weinstock-Guttman B, Ramanathan M. Lipid profile is associated with decreased fatigue in individuals with progressive multiple sclerosis following a diet-based intervention: Results from a pilot study. PLoS One. 2019 Jun 18;14(6):e0218075. doi: 10.1371/journal.pone.0218075. eCollection 2019. — View Citation
Irish AK, Erickson CM, Wahls TL, Snetselaar LG, Darling WG. Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2017 Jan 4;7:1-18. doi: 10.2147/DNND.S116949. eCollection 2017. — View Citation
Lee JE, Bisht B, Hall MJ, Rubenstein LM, Louison R, Klein DT, Wahls TL. A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis. J Am Coll Nutr. 2017 Mar-Apr;36(3):150-168. doi: 10.1080/07315724.2016.1255160. Epub 2017 Apr 10. — View Citation
Reese D, Shivapour ET, Wahls TL, Dudley-Javoroski SD, Shields R. Neuromuscular electrical stimulation and dietary interventions to reduce oxidative stress in a secondary progressive multiple sclerosis patient leads to marked gains in function: a case report. Cases J. 2009 Aug 10;2:7601. doi: 10.4076/1757-1626-2-7601. — View Citation
Wahls TL, Chenard CA, Snetselaar LG. Review of Two Popular Eating Plans within the Multiple Sclerosis Community: Low Saturated Fat and Modified Paleolithic. Nutrients. 2019 Feb 7;11(2):352. doi: 10.3390/nu11020352. — View Citation
Wahls TL, Reese D, Kaplan D, Darling WG. Rehabilitation with neuromuscular electrical stimulation leads to functional gains in ambulation in patients with secondary progressive and primary progressive multiple sclerosis: a case series report. J Altern Complement Med. 2010 Dec;16(12):1343-9. doi: 10.1089/acm.2010.0080. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MS 54 Quality of Life scale physical health score | Composite scores for physical health subscales | change from baseline to 12 months | |
Primary | MS 54 Quality of Life scale mental health score | Composite scores for mental health subscales | change from baseline to 12 months | |
Secondary | Anxiety Score -Hospital Anxiety and Depression Survey | Survey asking about mood and daily activities. Change in anxiety score for the hospital anxiety and depression scale score based on the responses. | change from baseline to 12 months | |
Secondary | Depression score -Hospital Anxiety and Depression Survey | Survey asking about mood and daily activities. Change in depress score for the hospital anxiety and depression scale score based on the responses. | change from baseline to 12 months | |
Secondary | Magnetic Resonance Imaging of CNS | Medical record abstraction of imaging results data (worse, stable, improved) | baseline to 6 months | |
Secondary | Magnetic Resonance Imaging of CNS | Medical record abstraction of imaging results data (worse, stable, improved) | baseline to 12 months | |
Secondary | Magnetic Resonance Imaging of CNS | Medical record abstraction of imaging results data (worse, stable, improved) | baseline to 18 months | |
Secondary | Magnetic Resonance Imaging of CNS | Medical record abstraction of imaging results data (worse, stable, improved) | baseline to 24 months | |
Secondary | MS Clinical symptoms over time | Medical record abstraction of function and MS symptoms from progress notes, (worse, stable, improved) | baseline to 6 months | |
Secondary | MS Clinical symptoms over time | Medical record abstraction of function and MS symptoms from progress notes (worse, stable, improved) | baseline to 12 months | |
Secondary | MS Clinical symptoms over time | Medical record abstraction of function and MS symptoms from progress notes (worse, stable, improved) | baseline to 18 months | |
Secondary | MS Clinical symptoms over time | Medical record abstraction of function and MS symptoms from progress notes (worse, stable, improved) | baseline to 24 months | |
Secondary | Dietary intake | Automated 24 hour dietary intake questionnaire completed online that asks questions about beverages and foods consumed in the prior 24 hours. | baseline to 12 months |
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