UMIN-CTR Clinical Trial

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
Email	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
Email	tuehara@neuro.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Neurology, Neurological Institute, Graduate School of Medicine, Kyushu University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033755