UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029570 |
|---|---|
| Receipt number | R000033755 |
| Scientific Title | Investigation for clinical factors contributing to accelerated long-term forgetting in epilepsy patients |
| Date of disclosure of the study information | 2017/10/26 |
| Last modified on | 2022/08/04 11:43:41 |
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Basic information
Public title
Investigation for clinical factors contributing to accelerated long-term forgetting in epilepsy patients
Acronym
Contributing factors for accelerated long-term forgetting in epilepsy
Scientific Title
Investigation for clinical factors contributing to accelerated long-term forgetting in epilepsy patients
Scientific Title:Acronym
Contributing factors for accelerated long-term forgetting in epilepsy
Region
| Japan |
Condition
Condition
Localization Related Epilepsy
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of interictal epileptic discharges and morphometric changes of brain on accelerated long-term forgetting(ALF) in patients with temporal lobe epilepsy
Basic objectives2
Others
Basic objectives -Others
Pathological mechanism
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between ALF and interictal epileptic discharges(IEDs) in non-REM sleep, or temporal lobe lesions in patients with temporal lobe epilepsy
Key secondary outcomes
Prevalence of ALF in temporal lobe epilepsy and extra-temporal lobe epilepsy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Neuropsychological exams(day1 & day7)
Brain MRI
Sleep EEG
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with clinically diagnosed localization related epilepsy
2. Patients are evaluated by board certified epileptologists. Localization related epilepsy is defined as follows;
(A) at least two unprovoked seizures occurring greater than 24 hours apart
(B) localization is evidenced by at least one of the following examinations; EEG recording, MRI, FDG-PET, SPECT or MEG
(C) ictal semiology is compatible to the lesions detected by examinations
3. Fluent in written and spoken Japanese
Key exclusion criteria
1. Estimated full scale IQ <70
2. Suspected aphasia with a screening test
3. History of epilepsy surgery
4. Neurological and psychiatric comorbidities
5. Any contraindications to MRI
6. History of residency in specific cities(Yanagawa city, Yukuhashi city and Beppu city) where movies for original neuropsychological examination were filmed
Target sample size
155
Research contact person
Name of lead principal investigator
| 1st name | Jun-ichi |
| Middle name | |
| Last name | Kira |
Organization
Graduate School of Medicine,
Kyushu University
Division name
Department of Neurology, Neurological Institute
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
092-642-5340
kira@neuro.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Taira |
| Middle name | |
| Last name | Uehara |
Organization
Graduate School of Medicine, Kyushu University
Division name
Department of Clinical Neurophysiology, Neurological Institute
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
092-642-5340
Homepage URL
tuehara@neuro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Neurological Institute,
Graduate School of Medicine,
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fukuoka Sanno Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital Institutional Review Board
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学病院（福岡県）、福岡山王病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/abs/10.1111/epi.17378
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1111/epi.17378
Number of participants that the trial has enrolled
80
Results
Multiple regression analyses showed a significant association between the left CA1 volume and the 1-week story retention, but this was not found for the whole hippocampus or other subfield volumes. Hippocampal shape analyses revealed that atrophy of the superior-lateral, superior-central, and inferior-medial regions of the left hippocampus, corresponding to CA1 and CA2/3, was associated with the verbal retention rate.
Results date posted
| 2022 | Year | 08 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
80 patients with focal epilepsy (61 with temporal lobe epilepsy and 19 with extratemporal lobe epilepsy) and 30 healthy controls.
Patients with focal epilepsy had lower intelligence quotients and route recall scores at 10 minutes than controls. The focal epilepsy group had smaller volumes of both the right and left hippocampal tails than the control group, but there were no significant group differences for the volumes of the whole hippocampus or other hippocampal subfields.
Participant flow
The patients underwent assessment of long-term memory, magnetic resonance imaging, and electroencephalography recording. Verbal and visuospatial memory was tested 30 seconds, 10 minutes, and 1 week after learning.
Adverse events
None
Outcome measures
We assessed the volumes of the whole hippocampus and seven subfields and deformation of the hippocampal shape.
The contributions of the hippocampal volumes and shape deformation to long-term forgetting, controlling for confounding factors, including the presence of interictal epileptiform discharges, were assessed by multiple regression analyses.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033755
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