UMIN-CTR Clinical Trial

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
Email

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
Email	g_oyama@juntendo.ac.jp

Sponsor
Institute	Juntendo University, Department of Neurology
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010486