UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008943 |
|---|---|
| Receipt number | R000010486 |
| Scientific Title | Prospective Randomized Controlled Study for Clinical Application of the Hanger Reflex to Treat Cervical Dystonia |
| Date of disclosure of the study information | 2012/09/24 |
| Last modified on | 2021/10/01 15:32:42 |
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Basic information
Public title
Prospective Randomized Controlled Study for Clinical Application of the Hanger Reflex to Treat Cervical Dystonia
Acronym
RCT Study for Hanger Reflex
Scientific Title
Prospective Randomized Controlled Study for Clinical Application of the Hanger Reflex to Treat Cervical Dystonia
Scientific Title:Acronym
RCT Study for Hanger Reflex
Region
| Japan |
Condition
Condition
Cevical dystonia
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess a portable device which induces the hanger reflex and to evaluate the efficacy of it for the cervical dystonia patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Toronto Western Spasmodic Torticollis Rating Scale and modified Tsui score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Put the device on the subject's head by proper way for 10 minutes during the study.
Interventions/Control_2
Put the device on the subject's head by ineffective way for 10 minutes during the study.
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
Patients with mainly rotational cervical dystonia.
Key exclusion criteria
1. Unstable symptom
2. Patients who cannnot understand the purpose of the study
3. Patients who are deemed to be disqualified by PI or co-investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Genko Oyama |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
+81-3-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Genko Oyama |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
+81-3-3813-3111
Homepage URL
g_oyama@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2012 | Year | 09 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2014 | Year | 12 | 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
| 2012 | Year | 09 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010486
