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临床试验/NCT02888925
NCT02888925Unknown不适用

Evaluation of Neuropsychological Effects of Drug-resistant Anterior Temporal Epilepsy and Anterior Temporal Lobectomy in Face Perception

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals

研究概览

简要总结

The purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face perception by comparison of performances of epileptic patients and control individuals, sex-, age- and socio-educational level-matched.

Secondary purposes are to prospectively evaluate neuropsychological impact of anterior temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face perception (exploratory study).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Informed consent
  • Affiliation to social security
  • Preliminary medical examination
  • PATIENTS WITH EPILEPSY:
  • Symptomatic drug-resistant anterior temporal epilepsy (confirmed with video-electroencephalography and magnetic resonance imaging and if necessary intracerebral SEEG exploration)
  • Patient needing anterior temporal lobectomy and undergoing pre-surgery conventional intercritical assessment for surgery decision
  • Nonverbal IQ ≥ 70 (WAIS-IV)
  • At least 6 successful VOSP tests (perception test)

排除标准

  • persons under legal protection or incapable to consent
  • Persons deprived of liberty by juridical or administrative decision
  • PATIENTS WITH EPILEPSY:
  • Sever visual disorders of neurological or ophthalmological origin
  • CONTROL INDIVIDUALS:
  • Psychiatric or neurological disorders
  • Important ophthalmological disorders

研究组 & 干预措施

Epilepsy

Other

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

干预措施: Mooney test (Other)

Epilepsy

Other

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

干预措施: Benton Face Recognition test (Other)

Epilepsy

Other

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

干预措施: Face inversion effect test (Other)

Epilepsy

Other

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

干预措施: Face composite effect test (Other)

Epilepsy

Other

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

干预措施: Cambridge Face Memory Test (Other)

Epilepsy

Other

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

干预措施: Matching different view test (Other)

Epilepsy

Other

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

干预措施: Memorizing and recognition of new faces test (Other)

Epilepsy

Other

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

干预措施: Memorizing and recognition of new objects test (Other)

Epilepsy

Other

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

干预措施: Recognition of celebrities and access to semantic information test (Other)

Epilepsy

Other

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

干预措施: Lobectomy (Procedure)

Control

Other

Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)

干预措施: Mooney test (Other)

Control

Other

Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)

干预措施: Benton Face Recognition test (Other)

Control

Other

Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)

干预措施: Face inversion effect test (Other)

Control

Other

Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)

干预措施: Face composite effect test (Other)

Control

Other

Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)

干预措施: Cambridge Face Memory Test (Other)

Control

Other

Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)

干预措施: Matching different view test (Other)

Control

Other

Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)

干预措施: Memorizing and recognition of new faces test (Other)

Control

Other

Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)

干预措施: Memorizing and recognition of new objects test (Other)

Control

Other

Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)

干预措施: Recognition of celebrities and access to semantic information test (Other)

结局指标

主要结局

Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals

时间窗: day 0

次要结局

  • Change of scores obtained with Benton test by epilepsy patients before and after lobectomy and control individuals (only patients having undergone anterior temporal lobectomy and matched control individuals)(day 0 and after 24 to 30 months)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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