Epilepsy Surgery and Cognitive Outcome

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy, Temporal Lobe
• Intervention / Treatment: Other: Neuropsychological examination

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.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 4950 Nydalen
    • Oslo University Hospital, Spesialsykehuset for epilepsi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Younger than 50 years of age; Patients who have undergone epilepsy surgery ten years ago or longer, and are currently less than 50 years of age	Other: Neuropsychological examination; Neuropsychological follow-up examination, including questionaires; Other Names: MRI scan
50 years of age or older; Patients who have undergone epilepsy surgery ten years ago or longer, and are currently 50 years of age or more	Other: Neuropsychological examination; Neuropsychological follow-up examination, including questionaires; Other Names: MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in each study group on neuropsychological tests of memory from baseline (preoperative) to current evaluation	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.	During single data collection session, aproximately 2 hours
Change in each study group on neuropsychological tests of language from baseline (preoperative) to current evaluation	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.	During single data collection session, aproximately 2 hours
Change in each study group on neuropsychological tests of visuospatial abilities from baseline (preoperative) to current evaluation	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.	During single data collection session, aproximately 2 hours
Change in each study group on neuropsychological tests of executive function from baseline (preoperative) to current evaluation	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.	During single data collection session, aproximately 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on depression questionaire	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).	During single data collection session, aproximately 2 hours
Score on anxiety questionaire	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).	During single data collection session, aproximately 2 hours
Score on quality of life inventory	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)	During single data collection session, aproximately 2 hours

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Eli B Kyte, Cand.psych, OUS - SSE

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Epilepsy; surgery; temporal lobe
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsies, Partial; Epilepsy; Epilepsy, Temporal Lobe
• Other Study ID Numbers: 651421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No