UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051793 |
|---|---|
| Receipt number | R000059093 |
| Scientific Title | Evaluating of Brain Activity through Transcranial Magnetic Stimulation on the Primary Auditory Cortex |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/02/02 10:40:16 |
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Basic information
Public title
Evaluating of Brain Activity through Transcranial Magnetic Stimulation on the Primary Auditory Cortex
Acronym
Evaluating of Brain Activity through Transcranial Magnetic Stimulation on the Primary Auditory Cortex
Scientific Title
Evaluating of Brain Activity through Transcranial Magnetic Stimulation on the Primary Auditory Cortex
Scientific Title:Acronym
Evaluating of Brain Activity through TMS on the Primary Auditory Cortex
Region
| Japan |
Condition
Condition
Sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Transcranial Magnetic Stimulation is utilized to non-invasively modulate auditory cortical activity, independent of the inner ear, and quantitatively evaluate the functional connectivity of central auditory neural circuits in individuals with hearing impairment through Electroencephalogram analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Latency and Amplitude of Transcranial Evoked Potential, and Time Frequency Analysis Power
Key secondary outcomes
Amplitude and Time-Frequency Analysis Power of Resting-state and Auditory Stimulus Task-elicited Brain Waves, Latency of Evoked Brain Waves during Auditory Stimulus Task, and Changes in these Measures before and after Cochlear Implant Surgery.
Correlation between Brain Wave Examination Results and Speech Discrimination Ability, Correlation between Cochlear Implant Thresholds and Speech Discrimination Ability at the Postoperative Six-month Mark, and Brain Wave Results.
Functional Connectivity of Various Cortical Regions in Resting-state MRI and Changes in Connectivity before and after Cochlear Implant Surgery.
Cognitive Function Evaluation (assessed with TMT, MMSE, and React Kyoto).
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
On the first day, an MRI measurement will be conducted, followed by brainwave (EEG) recording and transcranial magnetic stimulation with EEG recording in the primary auditory cortex within two months. The MRI measurement is expected to take approximately 30 minutes. For the EEG recording and TMS-EEG sessions, the process will include the attachment of the EEG cap (15 minutes), recording of brainwaves during task and rest conditions (40 minutes), and TMS-EEG recording (80 minutes, including conditions with TMS pulses and skin stimulation only). The total time required for the EEG and TMS-EEG recordings is estimated to be around 2 hours. There will be no observation period before or after the measurements.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
For individuals with normal hearing, there should be no self-awareness of hearing impairment and no indication of hearing loss in the past five years of health checkups.
For individuals with hearing impairment, they will be classified into one of the following categories based on their hearing test results: mild hearing loss (25 dB or more and less than 40 dB), moderate hearing loss (40 dB or more and less than 70 dB), severe hearing loss (70 dB or more and less than 90 dB), or profound hearing loss (90 dB or more).
No history of neurological disorders.
Must have a physique that allows for wearing headgear.
Key exclusion criteria
Have difficulty understanding explanations or instructions due to cognitive impairments.
Have a history of organic brain disorders or neurological diseases in the family.
Have a pacemaker implanted.
Already have a cochlear implant.
Have non-ferromagnetic materials in the body that cannot be confirmed to be non-magnetic (such as aneurysm clips, mechanical heart valves, neural stimulation devices, insulin pumps, intraocular metals, etc.).
If deemed unsuitable based on the "Transcranial Magnetic Stimulation (TMS) Examination Pre-checklist" and the "MRI Examination Pre-checklist."
Any other individuals deemed inappropriate as research subjects by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Oe |
Organization
Kyoto University
Division name
Graduate School of Medicine, Dept. of ORL-HNS
Zip code
606-8507
Address
54, Shogoin Kawaharacho, Sakyoku, Kyoto city, Kyoto Prefecture
TEL
075-751-3346
k_ooe@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Oe |
Organization
Kyoto University
Division name
Graduate School of Medicine, Dept. of ORL-HNS
Zip code
606-8391
Address
54, Shogoin Kawaharacho, Sakyoku, Kyoto city, Kyoto Prefecture
TEL
09066477514
Homepage URL
ent-hearing-brain@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Kyoto University
Address
54, Shogoin Kawaharacho, Sakyoku, Kyoto city, Kyoto Prefecture
Tel
075-751-3346
ent-hearing-brain@ent.kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 01 | 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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2027 | 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 | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059093
