- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01421446
Study to Validate a Computerized Neuropsychological Test Battery
Reliability and Validity of Umea Computerized Neuropsychological Battery
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Cognitive decline is one of the primary symptom triad of Normal Pressure Hydrocephalus (NPH). Neuropsychological measures have been demonstrated as being effective in the diagnosis of NPH, and in assessing the efficacy of treatment intervention. Hence, neuropsychological assessment is a critical component in the assessment for the presence of NPH. Specifically, measures of attention/concentration, fine motor skills, executive functioning abilities, speed of processing and memory have been found to be useful in the assessment of NPH and treatments thereof.
Neuropsychologists are typically found in large hospitals, academic centers and in urban locations. Neuropsychologists are under represented in rural or low population centers. At the present time, cognitive assessment is frequently limited to a Mini Mental Status Examination. Furthermore, neuropsychological testing can be very expensive for patients, given insurance constraints. Finally, there is no standardized test battery that is used in different centers treating this patient population. The creation of a standard battery that could be used in other NPH centers would promote research collaboration.
A computerized neuropsychological test battery was developed in Umea, Sweden with the specific goal of using tests that are considered to be sensitive to the cognitive profile observed in NPH. The battery was developed in JAVA and Adobe Flash making it platform independent (Runs on Mac, Windows and Linux). The test battery is administered on a touch screen display, where the tests are presented through animations with audio instructions. Before the real test trails are administered, subjects are given practice trials with auditory and visual feedback. For the American version of the test, the auditory stimuli have been translated and recorded in English.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21209
- Sandra and Malcolm Berman Brain & Spine Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age 60-80
Exclusion Criteria:
- Neurological disorder that results in motor or cognitive dysfunction
- Perceptual or motor difficulties that would prevent subjects from taking the assessment
- MMSE score <20
- MoCA score <26
- MAS score >9
- Significant abnormal neurologic examination findings
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Computer Hydrocephalus Neuropsychological Assessment Versions 1 & 2
Délai: Within 2-5 weeks of enrollment
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Within 2-5 weeks of enrollment
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Standard Hydrocephalus Neuropsychological Assessment: Versions 1 & 2
Délai: Within 2-5 weeks of enrollment
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Within 2-5 weeks of enrollment
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Michael A Williams, MD, LifeBridge Health
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- BSI-LBH 1735
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