UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033202
Receipt number 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 20:10:43

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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 or person

Institute

Tokyo Medical and Dntal University

Institute

Department

Personal name



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

Value
https://center6.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