UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009406 |
|---|---|
| Receipt number | R000011053 |
| Scientific Title | Study of electrophysiological change caused by botulinum toxin injections |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2024/06/07 13:00:45 |
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Basic information
Public title
Study of electrophysiological change caused by botulinum toxin injections
Acronym
Study of electrophysiological change caused by botulinum toxin injections
Scientific Title
Study of electrophysiological change caused by botulinum toxin injections
Scientific Title:Acronym
Study of electrophysiological change caused by botulinum toxin injections
Region
| Japan |
Condition
Condition
Stroke, head trauma, spinal cord disease, cerebral palsy
Classification by specialty
| Neurology | Pediatrics | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmed electrophysiological changes caused by botulinum toxin injections. Appearance and disappearance of the findings confirm denervation, neuromuscular junction whether full recovery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Needle EMG performed before and after botulinum toxin injections.
To confirm the denervation,polyphasic action potential, recruitment and interference pattern of motor unit potential.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with botulinum toxin injections for the treatment of spasticity for the first time.
Key exclusion criteria
Radiculopathy, peripheral neuropathy, neuromuscular disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Yasunaga |
Organization
Kawasaki Medical School Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
577 Matsushima, Kurashiki, Okayama Prefecture
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kawasaki Medical School Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
TEL
086-462-1111
Homepage URL
Sponsor or person
Institute
Kawasaki Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2013 | Year | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 06 | Month | 07 | Day |
Other
Other related information
Needle EMG performed before and after botulinum toxin injections.
To confirm the denervation,polyphasic action potential, recruitment and interference pattern of motor unit potential.
Management information
Registered date
| 2012 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011053
