Epilepsy, Temporal LobeNCT04264780
Epilepsy Surgery and Cognitive Outcome
An observational study of Epilepsy, Temporal Lobe, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Epilepsy, Temporal Lobe
- What is being tested?
- Neuropsychological examination
- How many people
- 102 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2019to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Prior temporal lobe epilepsy surgery (10 years ago or more)
Who cannot join
- Intelligence quotient (IQ) less than 70
- Other main language than Norwegian
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Spesialsykehuset for epilepsi
Oslo, 4950 Nydalen
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy, Temporal Lobe
- Being tested
- Neuropsychological examination
- Keywords
- Epilepsy, surgery, temporal lobe
- Medical subject headings
- Epilepsy, Temporal Lobe, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological examinationOther
Also called MRI scan
Neuropsychological follow-up examination, including questionaires
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Neuropsychological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During single data collection session, aproximately 2 hours
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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)
Measured: During single data collection session, aproximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start15 Aug 2019
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Temporal LobeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eli Berit Kyte, Oslo University Hospital
- Investigators
- Eli B Kyte, Cand.psych, Principal investigator, OUS - SSE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264780
- Sponsor's protocol ID
- 651421
- Status last verified
- Oct 2023
- First submitted
- 15 Apr 2019
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy Surgery and Cognition, Psychiatric Function and Quality of Life - Outcome 10 Years or More After Surgery
- ClinicalTrials.gov ID
- NCT04264780
- Acronym / sponsor ID
- 651421
- Conditions
- Epilepsy, Temporal Lobe
- Keywords
- Epilepsy, surgery, temporal lobe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger than 50 years of age | – | Other: Neuropsychological examinationPatients who have undergone epilepsy surgery ten years ago or longer, and are currently less than 50 years of age |
| 50 years of age or older | – | Other: Neuropsychological examinationPatients who have undergone epilepsy surgery ten years ago or longer, and are currently 50 years of age or more |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Prior temporal lobe epilepsy surgery (10 years ago or more)
Key exclusion criteria (2 listed)
- Intelligence quotient (IQ) less than 70
- Other main language than Norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological examinationAlso: MRI scanNeuropsychological follow-up examination, including questionaires | Other | 50 years of age or older, Younger than 50 years of age |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Score on depression questionaire
Time frame: During single data collection session, aproximately 2 hours
Score on anxiety questionaire
Time frame: During single data collection session, aproximately 2 hours
Score on quality of life inventory
Time frame: During single data collection session, aproximately 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Epilepsy, Temporal Lobe
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
Recruiting
Overnight TI in TLE
Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy
RecruitingEarly Phase 1
Pharmacological Modulation of Brain Oscillations in Memory Processing
Epilepsy, Seizures
Not yet recruitingObservational study
Studying Heart Rhythms With a Wearable Sensor to Detect and Predict Seizures in People With Epilepsy
Epilepsy, Temporal Lobe, Drug Resistant Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli B Kyte, Cand.psych principal investigator
OUS - SSE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, Temporal Lobe, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.