UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Clinical Effects for the Treatment of Cervical Dystonia Using Devices Induce the Hanger Reflex
Title of the study (Brief title)	Effects for Cervical Dystonia Using Devices Induce the Hanger Reflex
Region	Japan

Condition
Condition	Cervical Dystonia
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate change of Toronto Western Spasmodic Torticollis Rating Scale after applying the device inducing the hanger reflex.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate changes between Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores before and 3 months after the trial
Key secondary outcomes

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Toronto Western Spasmodic Torticollis Rating Scale
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	(1)Patients diagnosed as cervical dystonia, and having restrection of head rotation. (3)Patients can visit hospital.
Key exclusion criteria	(1)Patients who don't have hanger reflex (2)Patients having a unstable disease, and possibility to change medicines during study (3)Patient ruled unfit by a doctor responsible for the study.
Target sample size	50

Research contact person
Name of lead principal investigator	Takashi Asahi
Organization	Kanazawa Neurosurgical Hospital
Division name	Department of Neurosurgery
Address	262-2 Goumachi, Nonoichi city, Kanazawa city, Ishikawa
TEL	076-246-5600
Email	takashi-tym@umin.ac.jp

Public contact
Name of contact person	Yukio Mukai
Organization	Administrative department
Division name	Administration section
Address	262-2 Goumachi, Nonoichi city, Kanazawa city, Ishikawa
TEL	076-246-5600
Homepage URL
Email	kn-spd@med.email.ne.jp

Sponsor
Institute	Kanazawa Neurosurgical Hospital
Institute
Department

Funding Source
Organization	The University of Electro-Communications
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	金沢脳神経外科病院（石川県）、済生会松山病院（愛媛県）、富永病院（大阪府）、福岡大学付属病院（福岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 02 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2015 Year 07 Month 28 Day
Anticipated trial start date	2015 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 02 Day
Last modified on	2017 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024565