UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057645 |
|---|---|
| Receipt number | R000065863 |
| Scientific Title | Investigation on the Discrimination of Stimulus Propagation to the Ulnar Nerve During Palmar Stimulation of the Median Nerve |
| Date of disclosure of the study information | 2025/05/15 |
| Last modified on | 2025/04/17 17:42:32 |
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Basic information
Public title
Investigation on the Discrimination of Stimulus Propagation to the Ulnar Nerve During Palmar Stimulation of the Median Nerve
Acronym
Investigation on the Discrimination of Stimulus Propagation to the Ulnar Nerve During Palmar Stimulation of the Median Nerve
Scientific Title
Investigation on the Discrimination of Stimulus Propagation to the Ulnar Nerve During Palmar Stimulation of the Median Nerve
Scientific Title:Acronym
Investigation on the Discrimination of Stimulus Propagation to the Ulnar Nerve During Palmar Stimulation of the Median Nerve
Region
| Japan |
Condition
Condition
Recurrent Branch of Median Nerve Palsy, Carpal Tunnel Syndrome
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In nerve conduction studies, palmar stimulation of the median nerve is valuable for evaluating carpal tunnel syndrome and recurrent branch of median nerve palsy. However, during palmar stimulation, stimulus may propagate to the deep branch of the ulnar nerve, potentially causing conduction block-like findings in the median nerve recording from the abductor pollicis brevis muscle between the palm and wrist. This phenomenon risks misdiagnosis of recurrent branch of median nerve palsy. The purpose of this study is to establish a simple method to distinguish stimulus propagation to the ulnar nerve during palmar stimulation. Specifically, we will examine whether median nerve stimulation can be differentiated from ulnar nerve stimulation by observing thumb movement patterns in healthy individuals, cases of recurrent branch of median nerve palsy, and cases of carpal tunnel syndrome.
Basic objectives2
Others
Basic objectives -Others
If this study establishes a simple method to distinguish stimulus propagation to the ulnar nerve during median nerve stimulation, it will improve the diagnostic accuracy of carpal tunnel syndrome and recurrent branch of median nerve palsy, preventing misdiagnosis. Additionally, it will contribute to improving the quality of nerve conduction studies and help determine appropriate treatment plans for patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Attempting to distinguish between median nerve stimulation and ulnar nerve stimulation by thumb movement patterns during wrist and palmar stimulation
Key secondary outcomes
Comparing waveforms produced by median and ulnar nerve stimulation at the wrist and palm to attempt electrophysiological differentiation between recurrent branch of median nerve palsy cases and stimulus propagation to the ulnar nerve
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
In 10 healthy subjects, the median and ulnar nerves at the wrist and palm will be stimulated while the fingers are in a resting position with mild flexion, and thumb movements will be observed and recorded. Stimulation conditions: Using a nerve conduction study device (Neuropack X), with a duration of 0.2ms, the stimulation intensity will be set to a level that produces visibly obvious thumb movement. The pattern of thumb movement (abduction, adduction, flexion, extension) will be recorded on video as an observation item, and differences between median and ulnar nerve stimulation will be compared. For the disease group, nerve conduction studies are necessary examinations in clinical practice, and videos will be recorded during these examinations. Videos will also be recorded during examinations performed as part of clinical care. Information will be collected from electronic medical records. Note that the conduction testing intervention is performed only once.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals suspected of having carpal tunnel syndrome and recurrent branch of median nerve palsy, as well as healthy individuals
Key exclusion criteria
Those who lack sufficient capacity to consent to research participation. Others whom the research director determines to be unsuitable
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Isamu |
| Middle name | |
| Last name | Yamakawa |
Organization
Shiga University of Medical Science
Division name
Department of Neurology
Zip code
520-2192
Address
Seta, Tsukinowa-Cho, Otsu-shi, Shiga, Japan
TEL
0775482160
isamu136@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Isamu |
| Middle name | |
| Last name | Yamakawa |
Organization
Shiga University of Medical Science
Division name
Department of Neurology
Zip code
520-2192
Address
Seta, Tsukinowa-Cho, Otsu-shi, Shiga, Japan
TEL
0775482160
Homepage URL
isamu136@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta, Tsukinowa-Cho, Otsu-shi, Shiga, Japan
Tel
0775482160
isamu136@belle.shiga-med.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
滋賀医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | 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
| 2025 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | 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
| 2025 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065863
