UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060479 |
|---|---|
| Receipt number | R000065475 |
| Scientific Title | Electrophysiological Evaluation of Neuromuscular Diseases Using Piezoelectric Sensors |
| Date of disclosure of the study information | 2026/01/27 |
| Last modified on | 2026/01/27 09:52:37 |
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Basic information
Public title
Electrophysiological Evaluation of Neuromuscular Diseases Using Piezoelectric Sensors
Acronym
Electrophysiological Evaluation of Neuromuscular Diseases Using Piezoelectric Sensors
Scientific Title
Electrophysiological Evaluation of Neuromuscular Diseases Using Piezoelectric Sensors
Scientific Title:Acronym
Electrophysiological Evaluation of Neuromuscular Diseases Using Piezoelectric Sensors
Region
| Japan |
Condition
Condition
Neuromuscular diseases (such as motor neuron diseases, peripheral nerve disorders, neuromuscular junction disorders, and muscle diseases) and patients without neuromuscular diseases
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of a clinical testing method using piezoelectric sensors for patients with neuromuscular diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Outcome Measure: Movement-related potentials (MRPs) (in the case of repetitive stimulation, the rate of change in MRPs)
Key secondary outcomes
Secondary Outcome Measure: Excitation-contraction coupling time (ECCT) (in the case of repetitive stimulation, the rate of change in ECCT)
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
Nerve conduction study
Examination using piezoelectric sensors
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study participants will include patients with neuromuscular diseases or those suspected of having neuromuscular abnormalities who are either outpatients or inpatients at our hospital, as well as patients without neuromuscular diseases.
Key exclusion criteria
1. When the study participant does not wish to undergo the examination.
2. When the principal investigator or co-investigator determines that the participant is not suitable for the study (e.g., patients with insufficient medical records).
3. Patients under 20 years of age.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Hisahara |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Neurology
Zip code
060-8543
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
neurol@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Bungo |
| Middle name | |
| Last name | Hirose |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Neurology
Zip code
060-8543
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
hirosebungo@gmail.com
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical 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
Sapporo Medical University School of Medicine
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Japan
Tel
011-611-2111
ji-rskk@sapmed.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
| 2026 | Year | 01 | Month | 27 | 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
| 2025 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065475
