UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053101 |
|---|---|
| Receipt number | R000060599 |
| Scientific Title | Proof-of-Concept Study on Home-Based EEG Systems as Alternatives to Long-term Electroencephalogram Monitoring. |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/12/15 14:23:56 |
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Basic information
Public title
Proof-of-Concept Study for Home-Based EEG as an Alternative to Hospital-Grade Brainwave Recording Devices.
Acronym
Home-Based EEG Proof-of-Concept Study
Scientific Title
Proof-of-Concept Study on Home-Based EEG Systems as Alternatives to Long-term Electroencephalogram Monitoring.
Scientific Title:Acronym
Home-Based EEG Systems Proof-of-Concept Study
Region
| Japan |
Condition
Condition
epilepsy
Classification by specialty
| Neurology | Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The developed at-home EEG device can be worn and measured by individuals other than clinical laboratory technicians. Additionally, it is necessary to verify whether the acquired EEG data is of equivalent quality to that obtained from existing long-term simultaneous EEG-video recordings, and if it can distinguish the EEG of epilepsy patients, potentially serving as an alternative method to long-term simultaneous EEG-video recording tests.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of whether EEG data acquired with the at-home EEG device is of equivalent quality to existing long-term simultaneous EEG-video recordings for distinguishing the EEG of epilepsy patients.
Key secondary outcomes
Evaluation of whether it can be worn and measured by individuals other than clinical laboratory technicians.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Home-Based EEG Recording
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
| 19 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Disease Name: Healthy individuals, and epilepsy patients.
(2) Disease/Stage: Patients requiring hospitalization for diagnosis and determination of treatment plan for epilepsy.
(3) Age: 19 years or older, under 60 years old.
(4) Gender: Male.
(5) Eligibility Criteria: Healthy individuals with no history of brain disease, and patients who are currently hospitalized at Tohoku University or the National Center of Neurology and Psychiatry for comprehensive diagnosis of epilepsy, including long-term simultaneous EEG-video recording, who have recorded abnormal waves in their EEGs, and whose head circumference is between 570mm and 600mm, making them suitable for wearing the at-home EEG device.
Key exclusion criteria
(1) Patients who cannot give consent to participate in the study.
(2) Patients with severe intellectual disabilities or neurodevelopmental disorders.
(3) Patients exhibiting severe psychiatric symptoms due to depression, bipolar disorder, etc.
(4) Patients with a history of status epilepticus.
(5) Others whom the principal investigator deems inappropriate for the study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | JinJin |
Organization
Tohoku University School of Medicine
Division name
Department of Epileptology
Zip code
980-8575
Address
Miyagi Prefecture, Sendai City, Aoba-ku, Seiryo-cho 2-1
TEL
0227177343
kazutaka.jin.e8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kazushi |
| Middle name | |
| Last name | Ukishiro |
Organization
Tohoku University School of Medicine
Division name
Department of Epileptology
Zip code
980-0875
Address
Miyagi Prefecture, Sendai City, Aoba-ku, Seiryo-cho 2-1
TEL
0227177343
Homepage URL
ukishirokazushi@gmail.com
Sponsor or person
Institute
Tohoku University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Bakelite Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
ed-kenkyo@grp.tohoku.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
| 2023 | Year | 12 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 12 | Month | 14 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060599
