Complementary and Alternative Care in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CAM Care in MS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01703429
• Other study ID #: BU-11A-1296
• Status: Recruiting
• Start date: June 2012
• Est. completion date: June 2030

Study information

• Verified date: February 2020
• Source: Bastyr University
• Contact: Research Assistant
• Email: neuroresearch[@]bastyr.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2030
• Est. primary completion date: June 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Bastyr University Clinical Research Center	Kenmore	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bastyr University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PROMIS: Global Health	This outcome measure will be used to assess general health and well-being in this CAM using cohort.	5 years
Primary	"CAM Therapies" survey	This survey has been developed to identify the complementary and alternative therapies most commonly used by individuals with MS. Results will be reported with descriptive statistics.	5 years
Secondary	Modified Expanded Disability Severity Score (EDSS)	The EDSS will be used to capture disease severity and rates of progression in this cohort.	5 years

External Links

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