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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009406
Receipt No. 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 2012/11/27

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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
Email

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
Email

Sponsor
Institute Kawasaki Medical School Hospital
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2012 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2012 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011053

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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