UMIN-CTR Clinical Trial

Basic information
Public title	Cognitive function assessed by recording of brain activity using multimodal methods
Acronym	Cognitive function assessed by recording of brain activity using multimodal methods
Scientific Title	Cognitive function assessed by recording of brain activity using multimodal methods
Scientific Title:Acronym	Cognitive function assessed by recording of brain activity using multimodal methods
Region	Japan

Condition
Condition	Epilepsy, Parkinson's disease, dystonia, stroke, brain tumor, cerebrovascular disease
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The goal of the study is to explore the neural representations of sensory stimuli and cognitive processes by measuring neural activity and stimulating the cortex and subcorticalareas.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The neural activities during cognitive tasks and the behavioral performances of the cognitive tasks by stimulation of the cortex will be evaluated. The evaluation will be performed before epileptogenic focus resection surgery (~4 weeks).
Key secondary outcomes	1. The neural activities during cognitive tasks and the behavioral performances of the cognitive tasks by stimulation of subcortical areas will be evaluated. The evaluation will be performed before the implantation of the stimulation device used in deep brain stimulation therapy (~2 week). 2. In patients undergoing epileptic focal resection, device implantation for deep brain stimulation therapy, brain tumors, or cerebrovascular disease surgery, functional magnetic resonance imaging are used to assess the activity of cortical and subcortical areas during cognitive tasks and at rest. Evaluations will be performed before the surgery, and 1 month and 6 month after the surgery.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Participants: Patients with epilepsy implanted with chronic subdural or depth electrodes for epileptogenic focus surgery. Duration: 2 ~ 4 weeks (1~3 hours / day) Study: Measuring neural activities from the cortex and subcortical area during cognitive tasks (visual, auditory, and tactile stimuli). Furthermore, evaluating the changes of cognitive performances by stimulating the cortical and subcortical areas. The parameters of stimulation are based on the conventional clinical functional mapping protocol.
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	16 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. In a good condition after the surgery. 2. Obtained informed consent from the patient
Key exclusion criteria	1. When the patient seems unfit to participate in the study such as restlessness and disturbance of consciousness. 2. a pacemaker is implanted. 3. the metal is in the body for use in surgery or drug injection. 4. there is a possibility that a piece of metal has been accidentally introduced into the body from working in the metal processing industry. 5. Claustrophobia; 6. Severe shortness of breath when lying down.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kensuke Middle name Last name Kawai
Organization	Jichi Medical University
Division name	Department of Neurosurgery
Zip code	329-0498
Address	3311-1, Yakushiji, Shimotsuke, Tochigi
TEL	0285-58-7373
Email	kenkawai-tky@jichi.ac.jp

Public contact
Name of contact person	1st name Kensuke Middle name Last name Kawai
Organization	Jichi Medical University
Division name	Department of Neurosurgery
Zip code	329-0498
Address	3311-1, Yakushiji, Shimotsuke, Tochigi
TEL	0285-58-7373
Homepage URL
Email	kenkawai-tky@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science (Grants-in-Aid for Scientific Research)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Jichi Medical University
Address	3311-1, Yakushiji, Shimotsuke, Tochigi
Tel	0285-58-7576
Email	rinri@jichi.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

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 12 Month 11 Day
Date of IRB	2020 Year 03 Month 24 Day
Anticipated trial start date	2020 Year 04 Month 06 Day
Last follow-up date	2025 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 06 Day
Last modified on	2020 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045685

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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