Observational Study to Establish Patient-Matched Population Norms for the Multiple Sclerosis Cognition Assessment Battery

The primary objective of the study is to develop MS patient-matched healthy population norms for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of the United States (US), France, and Italy.

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Key information

Conditions

Healthy

Age range

25 year–58 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research site, Marseille, Bouches-du-Rhône, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
Must be in good health as determined by the Investigator, based on medical history, physical examination, and Screening evaluations.
Must be a native language speaker of the country where the study is being conducted.

Key Exclusion Criteria:

Neurological illnesses/conditions, such as motor or vocal tics (including a diagnosis of Tourette's syndrome), head trauma with significant loss of consciousness (>30 min), cerebral ischemia, carotid artery disease, epilepsy, brain tumor, dementia (including mild cognitive impairment and Alzheimer's disease), chronic meningitis, multiple sclerosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease.
Medical illnesses/conditions that may affect brain function, such as untreated hypertension (blood pressure >140/100 mm Hg), cardiac disease, insulin-dependent diabetes mellitus, endocrine disorders, renal disease, glaucoma, and chronic obstructive pulmonary disease.
Major psychiatric disturbance according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (US) Axis I criteria [American Psychiatric Association 2013] and the International Statistical Classification of Diseases and Related Health Problems, 10th revision Axis I criteria (Europe) [WHO 2010].
History of developmental disorders.

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Treatment and study plan

Primary outcomes

Selective Reminding Test (SRT) Score

Time frame: Day 1

The SRT measures verbal learning and memory. A participant is read a list of words and then asked to recall as many of the words as possible. Six learning trials are conducted, followed by a delay trial approximately 20 to 40 minutes later.
Brief Visuospatial Memory Test-Revised (BVMT-R) Score

Time frame: Day 1

The BVMT-R measures visual learning and memory. The stimulus page is presented for 10 seconds, and the participant is then asked to reproduce the designs as accurately as possible and in the same location on the page. Three learning trials are administered, followed by a delay trial approximately 20 to 40 minutes later. Immediately following the delay trial a recognition trial is administered to see whether the participant recognizes the figures that were on the display.
2- second and 3-second Paced Auditory Serial Addition Test (PASAT) Score

Time frame: Day 1

The PASAT assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 2- and 3- second PASAT, numbers are presented at a rate of 1 every 2 or 3 seconds, respectively.
Symbol Digit Modalities Test (SDMT) Score

Time frame: Day 1

SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

Study to Establish Patient-Matched Population Norms for the MS-COG

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 5, 2014
Registry last updated: Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed