Epilepsy Surgery and Cognitive Outcome

NCT04264780 | Completed

• 1 other identifier: 651421
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Temporal Lobe

Keywords

Epilepsy; surgery; temporal lobe

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Score on depression questionaire

  During single data collection session, aproximately 2 hours

• Score on anxiety questionaire

  During single data collection session, aproximately 2 hours

• Score on quality of life inventory

  During single data collection session, aproximately 2 hours

Study Arms (2)

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

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

Interventions

Neuropsychological examination OTHER

Neuropsychological follow-up examination, including questionaires

Also known as: MRI scan

50 years of age or older; Younger than 50 years of age

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Spesialsykehuset for epilepsi

Oslo, 4950 Nydalen, Norway

Location

MeSH Terms

Conditions

Epilepsy, Temporal Lobe; Epilepsy

Interventions

Neuropsychological Tests; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Eli B Kyte, Cand.psych

  OUS - SSE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: February 11, 2020
• Study Start: August 15, 2019
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

NO (1)