Multiple SclerosisCAM Care in MSNCT01703429
Complementary and Alternative Care in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Bastyr University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any individual with multiple sclerosis is invited to participate.
Who may be able to join
- 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
Who cannot join
- Inability to read/write in English
- Inability or unwillingness to complete surveys every six (6) months. (~ 90 min)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Research Assistant contact
United States1 site, 1 recruiting
- Recruiting
Bastyr University Clinical Research Center
Kenmore, Washington, 98028
Laurie K Mischley, ND, PhD, MPH, 425-602-3306, neuroresearch@bastyr.edu
Laurie K Mischley, ND, PhD, MPH
About this study
Official title: Complementary and Alternative Medicine (CAM) in Multiple Sclerosis. A Prospective Observational Study of a CAM-using Cohort
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.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, Complementary and Alternative, CAM
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with MS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: 5 years
Secondary outcomes (1)
Modified Expanded Disability Severity Score (EDSS)
The EDSS will be used to capture disease severity and rates of progression in this cohort.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurie Mischley, Bastyr University
- Investigators
- Laurie K Mischley, ND, PhD, MPH, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703429
- Sponsor's protocol ID
- BU-11A-1296
- Acronym
- CAM Care in MS
- Status last verified
- Feb 2020
- First submitted
- 3 Oct 2012
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary and Alternative Medicine (CAM) in Multiple Sclerosis. A Prospective Observational Study of a CAM-using Cohort
- ClinicalTrials.gov ID
- NCT01703429
- Acronym / sponsor ID
- CAM Care in MS / BU-11A-1296
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, Complementary and Alternative, CAM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 10 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with MS | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any individual with multiple sclerosis is invited to participate.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to read/write in English
- Inability or unwillingness to complete surveys every six (6) months. (~ 90 min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
"CAM Therapies" survey
Time frame: 5 years
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.
1 secondary outcome
Modified Expanded Disability Severity Score (EDSS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
Related trials for Multiple Sclerosis
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking
Multiple Sclerosis
Recruiting
HOBSCOTCH-MS-Efficacy Trial
Multiple Sclerosis, Cognitive Dysfunction
RecruitingPhase 1/2
A Study of AZD0120 in Autoimmune Diseases
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Research Assistant contact
Laurie K Mischley, ND, PhD, MPH principal investigator
Bastyr University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bastyr University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Assistant (neuroresearch@bastyr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"CAM Therapies" survey (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.