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Completed

NCT Number: NCT04264780

Epilepsy Surgery and Cognitive Outcome

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.

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Key information

Conditions

Epilepsy, Temporal Lobe Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Epileptic Syndromes Nervous System Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital, Spesialsykehuset for epilepsi

Oslo, 4950 Nydalen, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuropsychological examination

Other

Neuropsychological follow-up examination, including questionaires

Other names: MRI scan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Score on depression questionaire

    Time frame: During single data collection session, aproximately 2 hours

    Beck Depression Inventory (raw scores divided in 4 categories: 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression and 29-63 serious depression).

  2. Score on anxiety questionaire

    Time frame: During single data collection session, aproximately 2 hours

    Beck Anxiety Inventory (raw scores divided in 4 categories: 0-7 minimal anxiety, 8-15 mild anxiety, 16-25 moderate anxiety and 26-63 serious anxiety).

  3. Score on quality of life inventory

    Time frame: During single data collection session, aproximately 2 hours

    Quality of Life in Epilepsy - QUOLIE 89 - results will be reported as overall score ranging from 26-worst, to 95-best, and converted to T-score with average 50, standard deviation 10)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2020
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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