- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00922831
Progression of Cognitive and Physical Symptoms in Multiple Sclerosis
April 10, 2018 updated by: MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
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.
Study Overview
Status
Withdrawn
Conditions
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 Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Neurology Care Clinic
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Hunter T Feaster, PsyD, MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Anticipated)
August 1, 2013
Study Completion (Anticipated)
August 1, 2013
Study Registration Dates
First Submitted
June 16, 2009
First Submitted That Met QC Criteria
June 16, 2009
First Posted (Estimate)
June 17, 2009
Study Record Updates
Last Update Posted (Actual)
April 12, 2018
Last Update Submitted That Met QC Criteria
April 10, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 080514
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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