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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001192
Other study ID # 830176
Secondary ID 83-M-0176
Status Completed
Phase N/A
First received November 3, 1999
Last updated June 30, 2017
Start date October 18, 1983
Est. completion date December 20, 2006

Study information

Verified date December 20, 2006
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will allow researchers to use various types of tests to evaluate cognitive and sensory functions. These tests, referred to as "batteries" will evaluate attention, executive functions, general intellectual functioning, language, memory, motor functions, orientation, personality, selected sensory and perceptual functions, vigilance (alertness), and visual-spatial functions. Children and adult patient will receive different test batteries.

The goals of this research study are to;

1. Create descriptions based on the performance of each patient on the test batteries. Then use this information to relate patient behavior to their neurophysiological, neuroradiological, and biochemical descriptions.

2. Define subgroups of patients based on their neurobehavior in order to decrease the variability of psychiatric diagnoses, treatments, and prognoses.


Description:

Neuropsychological tests are used to provide an assessment of cognitive functions in patients with idiopathic generalized epileptic (IGE) disorders and their first-degree relatives. The battery comprises tests designed to tap attention, memory, selected sensory and perceptual functions, vigilance, and visual-spatial functions. Modified batteries have been developed for the assessment of children ages 5-8, and children ages 8-16. The data provided by these batteries are compared with genetic profiles of the same participants that have been ascertained from blood samples analyzed by colleagues at the Mount Sinai School of Medicine/Columbia University in New York City.


Recruitment information / eligibility

Status Completed
Enrollment 4300
Est. completion date December 20, 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 95 Years
Eligibility - INCLUSION CRITERIA:

Patients.

Normal volunteers.

EXCLUSION CRITERIA:

Subjects over 95 years of age.

Subjects with a history of alcohol or drug abuse, psychopathology, or central nervous system pathology, other than that which defines group membership, may be excluded.

Study Design


Locations

Country Name City State
France Genethon Every Cedex
Russian Federation Mosco Research Institute of Psychiatry Moscow
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland
United States Henry Ford Health Systems Detroit Michigan
United States Columbia University New York New York
United States Mt. Sinai Medical Center New York New York
United States Childrens National Medical Center Washington, D.C. District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  France,  Russian Federation, 

References & Publications (1)

Johnstone EC, Owens DG, Bydder GM, Colter N, Crow TJ, Frith CD. The spectrum of structural brain changes in schizophrenia: age of onset as a predictor of cognitive and clinical impairments and their cerebral correlates. Psychol Med. 1989 Feb;19(1):91-103. — View Citation

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