UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathophysiology of speech and voice disorders in Parkinson's disease patients treated with deep brain stimulation
Title of the study (Brief title)	Speech and voice disorders after deep brain stimulation
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we analyze speech and voice disorders observed during the contact screening test in detail. We aim to reveal the pathophysiology of speech and voice disorders in Parkinson's disease patients treated with deep brain stimulation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The correlation between speech and voice disorders and the electrode positions
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	One month after deep brain stimulation surgery, we perform the contact-screeing test. The correlation between speech and voice disorders and the electrode positions is analyzed.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Parkinson's disease patients who undergo deep barain stimulation in Nagoya university hospital.
Key exclusion criteria	Patients with further neurological disease, severe cognitive impairment or psychiatric disorders that may hinder the assessment.
Target sample size	20

Research contact person
Name of lead principal investigator	Masahisa Katsuno
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Neurology
Address	Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2391
Email	ka2no@med.nagoya-u.ac.jp

Public contact
Name of contact person	Takashi Tsuboi
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Neurology
Address	Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2391
Homepage URL
Email	takashi80@gmail.com

Sponsor
Institute	Nagoya university
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 28 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 06 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 06 Month 07 Day
Last modified on	2018 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026103