UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The intervention study of the swallowing exercise in patients with SBMA(spinal and bulbar muscular atrophy)
Title of the study (Brief title)	swallowing exercise in SBMA
Region	Japan

Condition
Condition	spinal and bulbar muscular atrophy (SBMA)
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of the head lift exercise (Shaker Exercise) in patients with spinal and bulbar muscular atrophy (SBMA)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	severity score of the laryngeal penetration in videofluorography
Key secondary outcomes	1)Pharyngeal and oral barium residue (%) in videofluorography 2)stage transition duration, duration of opening upper esophageal sphincter, laryngeal elevation duration, times of swallowing in videofluorography 3)Dysphagia Function Questionnaire 4)motor functional scales 5)serum examination(serum substance P) 6)measurment of tongue pressure 7)Tongue MRI

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Shaker Exercise
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	1)Patients (males) in a genetic test with number of the CAG repeat of the androgen receptor gene more than 38 2)Patients with muscle weakness due to a lower motor neuron 3)Patients are between20 and 80 years old at the time of the agreement acquisition 4)Patients who are capable of ambulatory hospital visits 5)Patient with written informed consent
Key exclusion criteria	1)Patients who have taken LH-RH agonists, an LH-RH antagonists, testosterone drugs, anti-androgen drugs, estrogen drugs or unapproved drugs within 48 weeks before agreement acquisition and patients who have taken 5-alpha-reductase inhibitors within 24 weeks before agreement acquisition. 2)Patient who have undergone operations(eg. orchiectomy), which reduce serum testosterone levels. 3)Patients who have severe complications. 4)Patients who can not do neck flexion in a decubitus. 5)Patients who have undergone operations of the head and neck including cervical spine. 6)Patients who are not appropriate to participate to the trial. 7)Patients who are unable to undergo videofluorography. 8)Patient who are unable to undergo MRI inspection.
Target sample size	10

Research contact person
Name of lead principal investigator	Gen Sobue
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Neurology
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550 Japan
TEL	052-744-2390
Email

Public contact
Name of contact person	Tomoo Mano
Organization	Department of Neurology
Division name	JASMITT clinical trial office
Address
TEL	052-744-2390
Homepage URL
Email

Sponsor
Institute	JASMITT clinical trial office, Department of Neurology, Nagoya University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	grants from the Ministry of Health, Labor and Welfare of Japan; and Core Research for Evolutional Science and Technology (CREST) from the Japan Science and Technology Agency (JST)
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	名古屋大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 28 Day
Anticipated trial start date	2012 Year 06 Month 28 Day
Last follow-up date	2013 Year 06 Month 28 Day
Date of closure to data entry	2013 Year 10 Month 01 Day
Date trial data considered complete	2013 Year 11 Month 01 Day
Date analysis concluded	2013 Year 12 Month 01 Day

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

Management information
Registered date	2013 Year 03 Month 19 Day
Last modified on	2016 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011208