Psychometric Validation of Cognitive Endpoints
This study has been completed.
Information provided by (Responsible Party):
John DeLuca, Kessler Foundation
First received: April 13, 2011
Last updated: May 1, 2012
Last verified: May 2012
The study will entail cognitive assessment of a single cohort of patients with Multiple Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no intervention or control group. Each participant will have a caregiver capable of responding to a brief report of observations regarding neuropsychological skills and abilities in the patient.
||Observational Model: Cohort
Time Perspective: Prospective
||Psychometric Validation of Cognitive Endpoints
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Individuals with Multiple Sclerosis
- 18 to 65 years old (inclusive).
- History of Relapsing-Remitting or Secondary Progressive Multiple Sclerosis
- Physically able to see the testing materials and complete the tests
- Have a family member or caregiver who is capable of consent and willing to complete the MSNQ-Informant questionnaire.
- A history of treated or untreated severe mental illness or diagnosis of major depression prior to MS onset.
- Untreated major depression or untreated anxiety disorder.
- History of Attention Deficit/Hyperactivity Disorder, Developmental Learning - Disorder including Mental Retardation.
- History of traumatic brain injury with intracranial bleed, stroke, Alzheimer's disease, Parkinson's disease, Motor Coordination Disorder or other neurologic illness. I understand that if the Investigator believes this would interfere with successful completion of the protocol, I will be excluded.
- A clinically significant relapse within the past 2 months. I have had a serious infection (e.g., pneumonia, septicemia) within the 2 month.
- History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to Study Day 1.
- Active bacterial or viral infection.
- Use of marijuana within 2 months prior to Study Day 1or at any time during the study
- Alcohol consumption within 24 hours of either test session.
- Unable to comply with study requirements.
- Expected survival time of less than 3 months.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335633
|Holy Name Hospital Multiple Sclerosis Center
|Teaneck, New Jersey, United States, 07666 |
|West Orange, New Jersey, United States, 07052 |
|University at Buffalo
|Buffalo, New York, United States, 14203 |
|Lauren S. Caruso
|White Plains, New York, United States, 10604 |
||John DeLuca, Ph.D.
No publications provided
||John DeLuca, Vice President of Research, Kessler Foundation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 13, 2011
||May 1, 2012
||United States: Institutional Review Board
Keywords provided by Kessler Foundation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Immune System Diseases
Nervous System Diseases