UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007772
Receipt number R000009153
Scientific Title Clinical Application of the Hanger Reflex to the Treatment of Cervical Dystonia
Date of disclosure of the study information 2012/04/16
Last modified on 2015/10/16 15:38:00

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Basic information

Public title

Clinical Application of the Hanger Reflex to the Treatment of Cervical Dystonia

Acronym

Treatment of Cervical Dystonia by Hanger reflex

Scientific Title

Clinical Application of the Hanger Reflex to the Treatment of Cervical Dystonia

Scientific Title:Acronym

Treatment of Cervical Dystonia by Hanger reflex

Region

Japan


Condition

Condition

Spasmodic torticolli (Cervical dystonia)

Classification by specialty

Neurology Neurosurgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will apply a portable device which induces the hanger reflex and 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

Phase I


Assessment

Primary outcomes

Evaluate by Toronto Western Spasmodic Torticollis Rating Scale and modified Tsui score after applying the portable device for 3 months.

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

Put on the device for more than 30 minutes per day
For three months

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients diagnosed as the cervical dystonia with mainly rotated symptom.

Key exclusion criteria

Patients who don't have the Hanger reflex.
Patients whose medication might be changed due to unstableness of their clinical condition.

Target sample size

54


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Asahi

Organization

University of Toyama

Division name

Department of Neurosurgery

Zip code


Address

2630 Sugitani, Toyama, Japan

TEL

076-434-7348

Email

takashi-tym@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Asahi

Organization

Toyama university hospital

Division name

Department of Neurosurgery

Zip code


Address

2630 Sugitani, Toyama, Japan

TEL

076-434-7348

Homepage URL


Email

takashi-tym@umin.ac.jp


Sponsor or person

Institute

University of Toyama

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


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

富山大学附属病院(富山県)、山口大学附属病院(山口県)、順天堂大学医学部附属浦安病院(千葉県)、順天堂大学医学部附属順天堂医院(東京都)、済生会松山病院(愛媛県)、長崎川棚医療センター(長崎県)


Other administrative information

Date of disclosure of the study information

2012 Year 04 Month 16 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

Completed

Date of protocol fixation

2012 Year 04 Month 09 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2015 Year 06 Month 01 Day

Date of closure to data entry

2015 Year 06 Month 01 Day

Date trial data considered complete

2015 Year 06 Month 01 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 04 Month 16 Day

Last modified on

2015 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009153


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name