UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retention effect of transcranial direct current stimulation and sensorimotor training on writer's cramp: a case report
Title of the study (Brief title)	Neuromodulation and sensorimotor training for writer's cramp
Region	Japan

Condition
Condition	Writer's cramp
Classification by specialty	Neurology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the retention effect of transcranial direct current stimulation and sensorimotor training in a patient with writer's cramp
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Severity of writer's cramp(Writer's cramp rating scale)
Key secondary outcomes	Muscle activity of forearm and shoulder during writing

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 Maneuver
Interventions/Control_1	transcranial direct current stimulation, relaxation and EMG biofeedback(four weeks)
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	40 years-old <
Age-upper limit	60 years-old >=
Gender	Female
Key inclusion criteria	diagnosis of writer's cramp
Key exclusion criteria	1. History of other neurological disorders and cardiovascular disease 2. presense of cardiac pacemaker 3. Family history of epilepsy
Target sample size	1

Research contact person
Name of lead principal investigator	Yohei Okada
Organization	Kio university
Division name	Department of physical therapy, Faculty of health science
Address	4-2-2 umimi-naka koryo-cho, kitakatsuragigun, Nara, 635-0832 Japan
TEL	+81-745-54-1601
Email	y.okada@kio.ac.jp

Public contact
Name of contact person	Yohei Okada
Organization	Kio university
Division name	Department of physical therapy, Faculty of health science
Address	4-2-2 umimi-naka koryo-cho, kitakatsuragigun, Nara, 635-0832 Japan
TEL	+81-745-54-1601
Homepage URL
Email	y.okada@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 21 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 10 Month 01 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 09 Month 21 Day
Last modified on	2016 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027769