UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Lomg-term postoperative evaluation of results after micro-vascular decompression
Title of the study (Brief title)	Long-term evaluation
Region	Japan

Condition
Condition	trigeminal neuralgia, hemi-facial spasm, glossopharyngeal neuralgia
Classification by specialty	Neurosurgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of efficacy and complication after micro-vascular decompression
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effect of operative therapy, complication
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	95 years-old >=
Gender	Male and Female
Key inclusion criteria	trigeminal neuralgia, facial spasm, glossopharyngeal neuralgia
Key exclusion criteria	non-typical facial pain, dystonia, non-typical glossopharyngeal neuralgia
Target sample size	200

Research contact person
Name of lead principal investigator	Hidetoshi Kasuya
Organization	Tokyo Women's Medical University Medical Center East
Division name	Department of Neurosurgery
Address	2-1-10 Nishiogu Arakawa-ku Tokyo
TEL	03-3810-1111
Email	hkasuya@twmu.ac.jp

Public contact
Name of contact person	Shigeru Tani
Organization	Tokyo Women's Medical University Medical Center East
Division name	Department of Neurosurgery
Address	2-1-10 Nishiogu Arakawa-ku Tokyo
TEL	03-3810-1111
Homepage URL
Email	stani@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University Medical Center East
Institute
Department

Funding Source
Organization	none
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	2024 Year 04 Month 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2012 Year 09 Month 21 Day
Anticipated trial start date	2018 Year 09 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	symptom, complication

Management information
Registered date	2018 Year 09 Month 19 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035815