UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062062 |
|---|---|
| Receipt number | R000071014 |
| Scientific Title | Somatosensory Evoked Potential Testing: Validation of the Alternating Left-Right Stimulation Method: The Time Limit for Modulating Contralateral Hemispheric Function via Peripheral Sensory Nerve Electrical Stimulation |
| Date of disclosure of the study information | 2026/06/26 |
| Last modified on | 2026/06/26 10:08:29 |
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Basic information
Public title
Elucidation of Interhemispheric Interaction Mechanisms Using Somatosensory Evoked Potential Testing
Acronym
Elucidation of Interhemispheric Interaction Mechanisms Using Somatosensory Evoked Potential Testing
Scientific Title
Somatosensory Evoked Potential Testing: Validation of the Alternating Left-Right Stimulation Method: The Time Limit for Modulating Contralateral Hemispheric Function via Peripheral Sensory Nerve Electrical Stimulation
Scientific Title:Acronym
Somatosensory Evoked Potential Testing: Validation of the Alternating Left-Right Stimulation Method: The Time Limit for Modulating Contralateral Hemispheric Function via Peripheral Sensory Nerve Electrical Stimulation
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Determine the threshold inter-stimulus interval (ISI) at which preceding contralateral stimulation ceases to affect the SEP waveforms (latency, amplitude, and morphology) of the test stimulus.
2. Compare SEPs elicited by upper-limb (median nerve) and lower-limb (tibial nerve) stimulation to examine differences in site-specific characteristics.
3. Validate the alternating left-right stimulation method and contribute to its appropriate application in clinical neurophysiological testing, rehabilitation research, and intraoperative monitoring.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
SEP Latency
UE:P14,N20,P23,N32,P40,N60,N11-N20
LE:P28,N31,P35,N42,P53,N66,N19-P35
Amplitude
UE:P14/N20,N20/P23,P23,N32
LE:P28/N31,N31/P35,P35/N42
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Although this is actually a single-blind randomized trial in which the antecedent stimulus is varied randomly for each subject, data entry is not possible due to a system bug.
The following procedures were performed on the median and tibial nerves (stimulation frequency: 2 Hz)
Upper and lower limbs: 8 conditions
(A) Right only, (A') Left only, (B) Simultaneous,
(C) ISI = 20 ms, (D) 50 ms, (E) 100 ms, (F) 150 ms, (G) 250 ms (alternating left and right)
Additional conditions for lower limbs only: 4 conditions
(B') 10 ms, (B'') 15 ms, (C') 25 ms, (C'') 30 ms
Total: 16 conditions (upper and lower limbs) + 4 conditions (lower limbs only) = 20 conditions
9-5. Stimulation parameters
Median nerve: 10 mA or less (intensity causing slight thumb movement)
Tibial nerve: 20 mA or less (intensity causing slight toe movement)
Analysis time: -110 to 190 ms
Frequency band: 2-2,000 Hz
Signal averaging: 500 trials
Each condition takes approximately 5 minutes, resulting in a total measurement time of approximately 90 minutes (proceeding from left to right in the figure below).
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults aged 18-50
2. Right-handed (LQ equal or more than 40 on the Edinburgh Handedness Inventory)
3. Individuals capable of voluntarily consenting to participate in the study
4. Individuals with no history of neurological abnormalities
Key exclusion criteria
History of central nervous system disorders or peripheral neuropathy
Metal plates implanted at the stimulation site
Implanted medical devices such as pacemakers
Use of medications affecting the nervous system
Pregnancy or potential pregnancy
Skin conditions making it difficult to attach stimulation electrodes
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Syoichi |
| Middle name | |
| Last name | Tashiro |
Organization
Kyorin University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1818611
Address
Shinkawa 6-20-2, Mitaka city, Tokyo
TEL
+81-422-47-5511
s-tashiro@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Syoichi |
| Middle name | |
| Last name | Tashiro |
Organization
Kyorin University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
181-8611
Address
Shinkawa 6-20-2, Mitaka city, Tokyo
TEL
+81-422-47-5511
Homepage URL
s-tashiro@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyorin University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Kyorin University School of Medicine
Address
Shinkawa 6-20-2, Mitaka city, Tokyo
Tel
+81-422-47-5511
irb@ks.kyorin-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
NA
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
IRB ID:R07-169
IRB approval number:900
Management information
Registered date
| 2026 | Year | 06 | Month | 26 | Day |
Last modified on
| 2026 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071014
