Epilepsy Surgery and Cognitive Outcome

Epilepsy, Temporal Lobe Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264780
• Other study ID #: 651421
• Status: Completed
• Start date: August 15, 2019
• Est. completion date: October 30, 2023

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe

Intervention

Other:
• Neuropsychological examination
Neuropsychological follow-up examination, including questionaires

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Spesialsykehuset for epilepsi	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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