Clinical trial NCT04264780: Epilepsy Surgery and Cognitive Outcome
Official title: Epilepsy Surgery and Cognition, Psychiatric Function and Quality of Life - Outcome 10 Years or More After Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy, Temporal Lobe
Keywords: Epilepsy
surgery
temporal lobe
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 102
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in Norway who have undergone temporal lobe epilepsy surgery ten years ago or more (all of these have also had a preoperative evaluation, including neuropsychological assessment), and who were 20 years of age or older at the time of surgery

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.

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

Primary outcomes:
measure: Change in each study group on neuropsychological tests of memory from baseline (preoperative) to current evaluation
timeFrame: During single data collection session, aproximately 2 hours
measure: Change in each study group on neuropsychological tests of language from baseline (preoperative) to current evaluation
timeFrame: During single data collection session, aproximately 2 hours
measure: Change in each study group on neuropsychological tests of visuospatial abilities from baseline (preoperative) to current evaluation
timeFrame: During single data collection session, aproximately 2 hours
measure: Change in each study group on neuropsychological tests of executive function from baseline (preoperative) to current evaluation
timeFrame: During single data collection session, aproximately 2 hours
Secondary outcomes:
measure: Score on depression questionaire
timeFrame: During single data collection session, aproximately 2 hours
measure: Score on anxiety questionaire
timeFrame: During single data collection session, aproximately 2 hours
measure: Score on quality of life inventory
timeFrame: During single data collection session, aproximately 2 hours
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Spesialsykehuset for epilepsi
Study officials:
affiliation: OUS - SSE
name: Eli B Kyte, Cand.psych
role: PRINCIPAL_INVESTIGATOR
References: