UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021301
Receipt number R000024565
Scientific Title Evaluation of Clinical Effects for the Treatment of Cervical Dystonia Using Devices Induce the Hanger Reflex
Date of disclosure of the study information 2016/03/02
Last modified on 2017/07/30 22:45:26

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Basic information

Public title

Evaluation of Clinical Effects for the Treatment of Cervical Dystonia Using Devices Induce the Hanger Reflex

Acronym

Effects for Cervical Dystonia Using Devices Induce the Hanger Reflex

Scientific Title

Evaluation of Clinical Effects for the Treatment of Cervical Dystonia Using Devices Induce the Hanger Reflex

Scientific Title:Acronym

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

1st name
Middle name
Last name Takashi Asahi

Organization

Kanazawa Neurosurgical Hospital

Division name

Department of Neurosurgery

Zip code


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

1st name
Middle name
Last name Yukio Mukai

Organization

Administrative department

Division name

Administration section

Zip code


Address

262-2 Goumachi, Nonoichi city, Kanazawa city, Ishikawa

TEL

076-246-5600

Homepage URL


Email

kn-spd@med.email.ne.jp


Sponsor or person

Institute

Kanazawa Neurosurgical Hospital

Institute

Department

Personal name



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)



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

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


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

Suspended

Date of protocol fixation

2015 Year 07 Month 28 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024565


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name