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Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04009005
Recruitment Status : Active, not recruiting
First Posted : July 5, 2019
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Terry L. Wahls, University of Iowa

Brief 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, 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.


Condition or disease Intervention/treatment Phase
Clinically Isolated Syndrome Relapsing Remitting Multiple Sclerosis Behavioral: Therapeutic diet and lifestyle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison of the intervention arm to standard of care.
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor blinded to study arm.
Primary Purpose: Treatment
Official Title: Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual care
Participants will receive usual care from their treating neurologist
Experimental: Therapeutic Lifestyle
Participants will be trained via videos from a three day in-person seminar that teaches the public about the use of a therapeutic diet and lifestyle to reduce multiple sclerosis related fatigue and improve quality of life.
Behavioral: Therapeutic diet and lifestyle
Educational videos, 1 individual support call from RD follwed by monthly support group meetings conducted via an internet based audio/ video conference platform. Patients will be trained on a low lectin modified paleolithic elimination diet; breathing meditation practice, and walking sessions to increase daily moderate to vigorous physiscal activity




Primary Outcome Measures :
  1. MS 54 Quality of Life scale physical health score [ Time Frame: change from baseline to 12 months ]
    Composite scores for physical health subscales

  2. MS 54 Quality of Life scale mental health score [ Time Frame: change from baseline to 12 months ]
    Composite scores for mental health subscales


Secondary Outcome Measures :
  1. Anxiety Score -Hospital Anxiety and Depression Survey [ Time Frame: change from baseline to 12 months ]
    Survey asking about mood and daily activities. Change in anxiety score for the hospital anxiety and depression scale score based on the responses.

  2. Depression score -Hospital Anxiety and Depression Survey [ Time Frame: change from baseline to 12 months ]
    Survey asking about mood and daily activities. Change in depress score for the hospital anxiety and depression scale score based on the responses.

  3. Magnetic Resonance Imaging of CNS [ Time Frame: baseline to 6 months ]
    Medical record abstraction of imaging results data (worse, stable, improved)

  4. Magnetic Resonance Imaging of CNS [ Time Frame: baseline to 12 months ]
    Medical record abstraction of imaging results data (worse, stable, improved)

  5. Magnetic Resonance Imaging of CNS [ Time Frame: baseline to 18 months ]
    Medical record abstraction of imaging results data (worse, stable, improved)

  6. Magnetic Resonance Imaging of CNS [ Time Frame: baseline to 24 months ]
    Medical record abstraction of imaging results data (worse, stable, improved)

  7. MS Clinical symptoms over time [ Time Frame: baseline to 6 months ]
    Medical record abstraction of function and MS symptoms from progress notes, (worse, stable, improved)

  8. MS Clinical symptoms over time [ Time Frame: baseline to 12 months ]
    Medical record abstraction of function and MS symptoms from progress notes (worse, stable, improved)

  9. MS Clinical symptoms over time [ Time Frame: baseline to 18 months ]
    Medical record abstraction of function and MS symptoms from progress notes (worse, stable, improved)

  10. MS Clinical symptoms over time [ Time Frame: baseline to 24 months ]
    Medical record abstraction of function and MS symptoms from progress notes (worse, stable, improved)

  11. Dietary intake [ Time Frame: baseline to 12 months ]
    Automated 24 hour dietary intake questionnaire completed online that asks questions about beverages and foods consumed in the prior 24 hours.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009005


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Terry L. Wahls
Investigators
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Principal Investigator: Terry L Wahls, MD University of Iowa
Publications:

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Responsible Party: Terry L. Wahls, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT04009005    
Other Study ID Numbers: 201908778
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Syndrome
Sclerosis
Disease
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases