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.
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 March 06, 2014
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases