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Neurocognitive Deficit clinical trials

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NCT ID: NCT05858489 Recruiting - Clinical trials for Neurocognitive Deficit

Concordance Between Mini-Mental Stats Examination (MMSE) and an Adapted Version of the MMSE in Reunion Island Population (MMS-Run)

MMS-R-ep
Start date: April 14, 2023
Phase:
Study type: Observational

Illeteracy concerns more than 38% of Réunion Island's people older than 65 years old, which makes it an important risk factor for dementia and a limit to neurocognitive test's administration. The MMSRun is a Mini Mental State Examination's version adapted to illeteracy and Réunionese culture, inspired by Hindi Mental State Examination's work. It allows a way better participation during neurocognitive evaluation, but it has never been validated. This study is a peliminary study to a validation, where the concordance between scores obtained from MMSRun and from the consensual version of Mini Mental State Examination proposed by GRECO (Groupe de Réflexion sur les Evaluations Cognitives) - the only french version validated - on a hospitalized and eldery population will be analyzed.

NCT ID: NCT05497427 Recruiting - Cognitive Decline Clinical Trials

Normative Database and Test-Retest Reliability for BrainCheck Assessments

NDTR
Start date: October 10, 2022
Phase:
Study type: Observational

The purpose of this study is to collect normative test values and demographic information for normative and referential data for a rapid, portable, computerized neurocognitive testing device from healthy adults 50 and older.

NCT ID: NCT04891471 Recruiting - Quality of Life Clinical Trials

WHOle Brain Irradiation or STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER)

WHOBI-STER
Start date: September 15, 2020
Phase: N/A
Study type: Interventional

This work aims to evaluate neurocognitive performance, daily activity and quality of life and local control among patients with brain metastasis (MBM) ≥ 5 due to solid tumors treated with Stereotactic RadioSurgery (SRS) or Whole Brain RadioTherapy (WBRT). This multicentric randomised controlled trial will be conducted at the Fondazione IOM (Viagrande) in collaboration with REM (Viagrande), Hospital G. Martino (Messina) and Hospital Civico ARNAS (Palermo). It will involve, within 5 years starting from 15 September 2020, the enrollment of 100 patients (50 for each arm) with MBM ≥ 5, age ≥ 18 years, Karnofsky Performance Status (KPS) ≥ 70, life expectancy > 3 months, histological confirmation of primary tumor, with controlled or controllable extracranial disease, baseline Montreal Cognitive Assessment (MoCA) of 20/30, Barthel Activities of Daily Living score 90/100, to be subjected to SRS on each brain lesion by LINAC with monoisocentric technique and non-coplanar arcs (experimental arm) or to WBRT (control arm). The primary endpoints are neurocognitive performance, quality of life and autonomy in daily-life activities variations, the first one assessed by Moca Score and Hopkins Verbal Learning Test - Revised, the second one through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL) and Brain Neoplasm (BN-20) questionnaires, the third one through the Barthel Index, respectively. The secondary endpoints are time to intracranial failure, overall survival, retreatments frequency, acute and late toxicities, KPS decrease. It will be considered significant a statistical difference of at least 29% between the two arms (statistical power of 80% with a significance level of 95%). This trial has been approved by the local ethics committee on July 7th 2020 (record 70). Several studies debate what is the predominant factor accountable for the development of neurocognitive decay among patients undergoing brain irradiation for MBM: radiotherapy, especially if extended to the entire brain, or intracranial disease progression? Answer to this question may come from current opportunity, thanks to recent technological advancement, to treat, with significant time savings, improved patient comfort and at the same time minimizing the dose to healthy brain tissue, Multiple Brain Metastasis simultaneously, otherwise attackable only by panencephalic irradiation. The pursuit of a local control rate comparable to that obtainable with WBRT remains the fundamental prerequisite for the aforementioned related assessments.

NCT ID: NCT04073966 Recruiting - Brain Metastases Clinical Trials

MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets

Start date: December 4, 2019
Phase:
Study type: Observational

Brain metastases are a source of much morbidity and mortality in adults with primary solid malignant tumors. With improvements in systemic therapy that prolong survival but have limited central nervous system penetration, patients with brain metastases are at increasing risk of developing and experiencing long-term side effects from treatment of brain metastases. The overarching goal of this study is to better understand the determinants of RT-associated changes in white and gray matter function and associated neurocognitive decline.