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临床试验/NCT04264780
NCT04264780已完成不适用

Epilepsy Surgery and Cognition, Psychiatric Function and Quality of Life - Outcome 10 Years or More After Surgery

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2019年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Change in each study group on neuropsychological tests of language from baseline (preoperative) to current evaluation

研究概览

简要总结

This study will give important information about long term consequences of temporal lobe epilepsy surgery on cognition (memory, language, concentration etc), psychiatric function and quality of life.

详细描述

All patients in Norway who have undergone temporal lobe epilepsy surgery ten years ago or more, will be invited to participate. Two groups will be compared: patients who are younger than 50 years of age vs patients who are older than 50 years of age.

The aim of the study is to improve preoperative information to future epilepsy surgery patients, to aid medical personnel (doctors, psychologists) in the selection of patients for surgery, and to improve knowledge of need for long term follow-up and rehabilitation.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prior temporal lobe epilepsy surgery (10 years ago or more)

排除标准

  • Intelligence quotient (IQ) less than 70
  • Other main language than Norwegian

结局指标

主要结局

Change in each study group on neuropsychological tests of language from baseline (preoperative) to current evaluation

时间窗: During single data collection session, aproximately 2 hours

Language will be measured by the subtest "Similarities" from Wechsler Adult Intelligence Scale - WAIS-III, results reported as raw scores from 1-worst to 33-best; Boston Naming Test-results reported as raw scores from 1-worst to 60-best; Letter Fluency from Delis Kaplan Executive Function Scale-D-KEFS, raw scores from 1-worst and up. All results will be converted to T-scores.

Change in each study group on neuropsychological tests of memory from baseline (preoperative) to current evaluation

时间窗: During single data collection session, aproximately 2 hours

Memory will be measured by Rey Auditory Verbal Learning Test, results reported as raw scores from 1-worst to 15-best; and Diagnosticum für Cerebralschädugung-Revised - DCS-R, results reported as raw scores from 1-worst to 15-best. All results will be converted to T-scores with average 50, standard deviation 10.

Change in each study group on neuropsychological tests of executive function from baseline (preoperative) to current evaluation

时间窗: During single data collection session, aproximately 2 hours

Executive function will be measured by the subtest "Digit Span" from WAIS-III, raw scores from 1-worst, to 30-best; Trails A and B from Halstead test battery, raw scores from 1-worst and up. All results will be converted to T-scores.

Change in each study group on neuropsychological tests of visuospatial abilities from baseline (preoperative) to current evaluation

时间窗: During single data collection session, aproximately 2 hours

Visuospatial abilities will be measured by the subtest "Block Design" from WAIS-III, raw scores from 1-worst to 68-best. Results will be converted to T-scores.

次要结局

  • Score on quality of life inventory(During single data collection session, aproximately 2 hours)
  • Score on depression questionaire(During single data collection session, aproximately 2 hours)
  • Score on anxiety questionaire(During single data collection session, aproximately 2 hours)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eli Berit Kyte

Psychologist

Oslo University Hospital

研究点 (1)

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