UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040073 |
|---|---|
| Receipt number | R000045685 |
| Scientific Title | Cognitive function assessed by recording of brain activity using multimodal methods |
| Date of disclosure of the study information | 2020/04/06 |
| Last modified on | 2022/11/04 10:02:12 |
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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 using electric stimulation to 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
| 8 | 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
3. Patients whose ages are more than 8 years old.
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
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
kenkawai-tky@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
| 2022 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045685
