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Recruiting NCT01703429

Complementary and Alternative Care in Multiple Sclerosis

Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Complementary and Alternative Medicine (CAM) in Multiple Sclerosis. A Prospective Observational Study of a CAM-using Cohort

Overview

This is a prospective, observational study designed to describe disease progression, symptom change, quality of life, diet and lifestyle habits, and frequency of adverse events among patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM). In addition to describing the patterns of CAM use, this study will also identify and describe the positive deviants, those individuals with the highest quality of life and least amount of disease activity. Positive deviants will be compared to controls in order to describe medication, diet, and lifestyle patterns associated with a lack of MS disease progression and high quality of life.

Primary outcome measures

  • "CAM Therapies" survey [Time frame: 5 years]
Secondary outcome measures (1)
  • Modified Expanded Disability Severity Score (EDSS) [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Diagnosis of multiple sclerosis (including relapsing remitting MS, secondary progressive MS, primary progressive MS, clinically isolated syndromes (CIS), radiologically-isolated syndromes (RIS), possible MS, or probable MS.
  • Age 18-100

Exclusion criteria

  • Inability to read/write in English
  • Inability or unwillingness to complete surveys every six (6) months. (\~ 90 min)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Bastyr University Clinical Research Center — Kenmore

Identifiers

NCT: NCT01703429 · BU-11A-1296

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗