UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of endoscopic microvascular decompression for trigeminal neuralgia and hemifacial spasm
Title of the study (Brief title)	Evaluation of endoscopic microvascular decompression
Region	Japan

Condition
Condition	trigeminal neuralgia, hemifacial spasm
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The object of this study is to evaluate efficacy and safety of endoscopic microvascular decompression for trigeminal neuralgia and hemihfacial spasm
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Barrow Neurological Institute pain intensity score and Kondo score at 6 months later of surgery
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	Maneuver
Interventions/Control_1	Endoscopic microvascular decompression is performed.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Medical management have failed prior to surgery. The patient hope to have surgical management.
Key exclusion criteria	General anesthesia is impossible. Affected nerve is compressed by an aneurysm or an brain tumor.
Target sample size	20

Research contact person
Name of lead principal investigator	Fuminari Komatsu
Organization	Tokai University Hachioji Hospital
Division name	Department of Neurosurgery
Address	1838 Ishikawa-machi, Hachioji, Tokyo, Japan
TEL	042-639-1111
Email	fuminarikomatsu@gmail.com

Public contact
Name of contact person	Fuminari Komatsu
Organization	Tokai University Hachioji Hospital
Division name	Department of Neurosurgery
Address	1838 Ishikawa-machi, Hachioji, Tokyo, Japan
TEL	042-639-1111
Homepage URL
Email	fuminarikomatsu@gmail.com

Sponsor
Institute	Department of Neurosurgery, Tokai University School of Medicine, Kanagawa, Japan
Institute
Department

Funding Source
Organization	Department of Neurosurgery, Tokai University School of Medicine, Kanagawa, Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Neurosurgery, Tokai University School of Medicine, Kanagawa, Japan
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	東海大学医学部付属八王子病院 東海大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 09 Day
Anticipated trial start date	2016 Year 04 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 04 Month 01 Day
Last modified on	2017 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025065