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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000033202
Receipt No. R000037809
Scientific Title Altered brain volume in neuropathic pain patients
Date of disclosure of the study information 2018/07/01
Last modified on 2020/02/05

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Basic information
Public title Altered brain volume in neuropathic pain patients
Acronym Altered brain volume in neuropathic pain patients
Scientific Title Altered brain volume in neuropathic pain patients
Scientific Title:Acronym Altered brain volume in neuropathic pain patients
Region
Japan

Condition
Condition Classiccal trigeminal neuralgia and neuropathic pain due to facial trauma (painful post-traumatic trigeminal neuropathy)
Classification by specialty
Neurology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the study of changes in brain volume, there are still few studies targeting pain in the oral facial pain region, and reports on the extent of changes in brain volume and areas with changes are also not consistent. In the report by Gustin et al., classical trigeminal neuralgia and neuropathic pain due to facial trauma are analyzed as the same group, but thease groups have clinical and etiologially differences. In this study, we examine the characteristics of changes in brain volume and cortical thickness of grey matter of typical trigeminal neuralgia group, neuropathic pain due to facial trauma (painful post-traumatic trigeminal neuropathy) group, control graoup of healthy subjects.
Basic objectives2 Others
Basic objectives -Others Presence or absence of brain volume change when having a disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in brain volume and cortical thickness of grey matter obtained from MRI images are compared in typical trigeminal neuralgia group, painful post-traumatic trigeminal neuropathy group, control group of healthy subjects.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 MRI examination is done once during the study period.
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 1. Control group: Sixty males and female healthy adults aged 20 to 80.
2. Trigeminal neuralgia group:Sixty males and female patients with classical trigeminal neuralgia aged 20 to 80 years visited the Orofacia Pain Clinic at the Tokyo Medical and Dntal University, Dental Hosipital.
3. Neuropathic pain due to facial trauma(painful post-traumatic trigeminal neuropathy)group: Sixty males and female patients with neuropathic pain due to injury of the facial area aged 20 to 80 years who visited the Orofacia Pain Clinic at the Tokyo Medical and Dntal University, Dental Hosipital.
Key exclusion criteria 1. Persons who have had some sort of pain in the maxillofacial area other than neuropathic pain due to trigeminal neuralgia or damage to the facial area by 4 weeks in advance. (In the control group, those who have had a history of some kind of pain in the maxillofacial area by 4 weeks before are excluded.)
2. Persons who have a history of neuraldia or psychiatric disorders in other parts. 3. Persons who have acute or chronic disease (multiple sclerosis, diabetes, herpes zoster etc.) causing pain.
4. Persons who are alcohol-dependent.
5. Persons wearing cardiac pacemakers.
6. Persons who have metals (arterial clips, intravascular stents, plates and bolts for repair and fixation, etc.) in the body.
7. Persons who are claustrophobic.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Shimada
Organization Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Division name Orofacial Pain Management
Zip code 113-8548
Address 1-5-45 Yushima Bunkyo-ku Tokyo
TEL 03-5803-4563
Email mshimada.ofpm@tmd.ac.jp

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Yamazaki
Organization Tokyo Medical and Dntal University, Dental Hosipital
Division name Orofacial Pain Clinic
Zip code 113-8549
Address 1-5-45 Yushima Bunkyo-ku Tokyo
TEL 03-5803-5762
Homepage URL
Email yamazaki-yo.ofpm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dntal University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Dental Research Ethics Committee of Tokyo Medical and Dental University
Address 1-5-45 Yushima Bunkyo-ku Tokyo
Tel 03-5803-5404
Email d-hyoka.adm@tmd.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 D2014-127-02
Org. issuing International ID_1 Dental Research Ethics Committee of Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学歯学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 90
Results
We observed a significantly smaller GMV in the right inferior temporal gyrus of both CTN and PPTN patients compared with HC. In addition, a significant GMV deficit was found in the right middle temporal gyrus in PPTN patients compared with HC. We also observed a smaller GMV in PPTN compared with CTN in the temporal and parietal cortices. Pain duration was negatively correlated with GMV in PPTN patients. 
Results date posted
2020 Year 02 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2014 Year 09 Month 17 Day
Date of IRB
2015 Year 03 Month 13 Day
Anticipated trial start date
2015 Year 03 Month 13 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 29 Day
Last modified on
2020 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037809

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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