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Clinical Trials/NCT04264780
NCT04264780
Completed
Not Applicable

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

Oslo University Hospital1 site in 1 country102 target enrollmentAugust 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy, Temporal Lobe
Sponsor
Oslo University Hospital
Enrollment
102
Locations
1
Primary Endpoint
Change in each study group on neuropsychological tests of language from baseline (preoperative) to current evaluation
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2019
End Date
October 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Eli Berit Kyte

Psychologist

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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