Active — Not RecruitingNot Applicable

Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis

United States44 participantsStarted 2020-05-01

Plain-language summary

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. 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. and having received a recommendation to begin disease modifying treatment (DMT)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) Taking insulin or Coumadin® medication. 3) History of oxalate kidney stones, schizophrenia, or active diagnosis of eating disorder. 4) Greater than 12 months since initial diagnosis of RRMS or CIS and first study visit.

What they're measuring

MS 54 Quality of Life scale physical health score

Timeframe: change from baseline to 12 months

MS 54 Quality of Life scale mental health score

Timeframe: change from baseline to 12 months

Trial details

NCT IDNCT04009005

SponsorTerry L. Wahls

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-01