ClinicalTrials.gg
CompletedNCT01335633Updated May 3, 2012

Psychometric Validation of Cognitive Endpoints

An observational study in Multiple Sclerosis, sponsored by Kessler Foundation. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-05-03.

Sponsored by Kessler Foundation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • MS
  • Neuropsychological tests
03

In context

Multiple Sclerosis

3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 1,034 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 174 studies on the registry; 60 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Individuals with Multiple Sclerosis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
06

Study locations

4 sites
  • Holy Name Hospital Multiple Sclerosis Center
    Teaneck, New Jersey 07666, United States
  • Kessler Foundation
    West Orange, New Jersey 07052, United States
  • University at Buffalo
    Buffalo, New York 14203, United States
  • Lauren S. Caruso
    White Plains, New York 10604, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2011
First posted
Apr 14, 2011
Start
Mar 2011
Primary completionActual
Aug 2011
CompletionActual
Aug 2011
Last update
May 3, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01335633
Lead sponsor
Kessler Foundation
Collaborators
Biogen
Responsible party
John DeLuca (Vice President of Research, Kessler Foundation) — Principal investigator
First posted
Apr 14, 2011
Start date
Mar 2011
Primary completion
Aug 2011
Completion
Aug 2011
Last update
May 3, 2012

Study contacts

John DeLuca, Ph.D.
principal investigator · Kessler Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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