Multiple SclerosisNCT00922831
Progression of Cognitive and Physical Symptoms in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute.
Trial summary
The purpose of this study is to look at multiple sclerosis patients process of awareness, learning, and judging status over a 3 year time period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neurology Care Clinic
Who may be able to join
- Male/female subjects at least 18 years of age with a diagnosis of Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS)as confirmed by a neurologist.
- Subjects must be able to give written informed consent and comply with the study protocol. Subjects must also be able to read, write and understand English.
- Are capable of performing the requirements of the neuropsychological test battery.
Who cannot join
- As judged by the investigator, any clinically significant, unstable or major concomitant disorder or medications.
- In the opinion of the Investigator should not participate in the study.
About this study
Official title: Progression of Cognitive, Affective, and Physical Symptoms in Multiple Sclerosis.
The purpose of this study is to look at multiple sclerosis patients process of awareness, learning, and judging status over a 3 year time period.
Read the detailed description
Patients with multiple sclerosis (MS) frequently experience cognitive and emotional difficulties. Theses neuropsychiatric symptoms are known to be associated with reduced quality of life. However, little is known about the evolution of MS patients' neuropsychiatric difficulties and how these neuropsychiatric changes may be related to other MS symptoms. The purpose of the present study is to examine MS patients' cognitive and emotional status over time as part of standard neuropsychological evaluations in a private practice setting. MS patients presenting for neuropsychological evaluation at the MidAmerica Neuroscience Institute will be provided with the option of participating in thorough evaluation of their cognitive and affective MS symptoms. They will then be followed clinically and receive re-evaluation over a period of 3 years on a yearly basis. It is hoped that this study will help us obtain a better understanding of the factors associated with worsening cognition in MS. A greater understanding of the factors associated with cognitive and affective decline in MS help could lead to the early identification and treatment of at-risk patients.
- Conditions
- Multiple Sclerosis
- Keywords
- Cognition, Affective MS symptoms
- Medical subject headings
- Multiple Sclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Why it stopped: Funding not available
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri, Kansas City
- Investigators
- Hunter T Feaster, PsyD, Principal investigator, MidAmerica Neuroscience Research Foundation at Rowe Neurology InstituteJared Bruce, PhD, Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922831
- Sponsor's protocol ID
- 080514
- Status last verified
- Apr 2018
- First submitted
- 16 Jun 2009
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Cognitive, Affective, and Physical Symptoms in Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT00922831
- Acronym / sponsor ID
- 080514
- Conditions
- Multiple Sclerosis
- Keywords
- Cognition, Affective MS symptoms
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MidAmerica Neuroscience Research Foundation at Rowe Neurology InstituteUniversity, hospital or other
- Collaborators
- University of Missouri, Kansas City
- Study start
- Aug 2008
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 17 Jun 2009 (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.
The purpose of this study is to look at multiple sclerosis patients process of awareness, learning, and judging status over a 3 year time period.
Detailed description
Patients with multiple sclerosis (MS) frequently experience cognitive and emotional difficulties. Theses neuropsychiatric symptoms are known to be associated with reduced quality of life. However, little is known about the evolution of MS patients' neuropsychiatric difficulties and how these neuropsychiatric changes may be related to other MS symptoms. The purpose of the present study is to examine MS patients' cognitive and emotional status over time as part of standard neuropsychological evaluations in a private practice setting. MS patients presenting for neuropsychological evaluation at the MidAmerica Neuroscience Institute will be provided with the option of participating in thorough evaluation of their cognitive and affective MS symptoms. They will then be followed clinically and receive re-evaluation over a period of 3 years on a yearly basis. It is hoped that this study will help us obtain a better understanding of the factors associated with worsening cognition in MS. A greater understanding of the factors associated with cognitive and affective decline in MS help could lead to the early identification and treatment of at-risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurology Care Clinic
Key inclusion criteria (3 listed)
- Male/female subjects at least 18 years of age with a diagnosis of Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS)as confirmed by a neurologist.
- Subjects must be able to give written informed consent and comply with the study protocol. Subjects must also be able to read, write and understand English.
- Are capable of performing the requirements of the neuropsychological test battery.
Key exclusion criteria (2 listed)
- As judged by the investigator, any clinically significant, unstable or major concomitant disorder or medications.
- In the opinion of the Investigator should not participate in the study.
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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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. This study is not recruiting at the moment.
Hunter T Feaster, PsyD principal investigator
MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
Jared Bruce, PhD principal investigator
University of Missouri, Kansas City
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute.
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 3 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: withdrawn, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 12 Apr 2018.