UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020000 |
|---|---|
| Receipt number | R000023089 |
| Scientific Title | Neural correlates of pain relief by tactile stimulation: An MEG study |
| Date of disclosure of the study information | 2015/11/30 |
| Last modified on | 2022/06/29 05:19:21 |
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Basic information
Public title
Neural correlates of pain relief by tactile stimulation: An MEG study
Acronym
Neural correlates of pain relief by tactile stimulation: An MEG study
Scientific Title
Neural correlates of pain relief by tactile stimulation: An MEG study
Scientific Title:Acronym
Neural correlates of pain relief by tactile stimulation: An MEG study
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the differences between the pain and tactile processing and clarify mechanism of the pain relief by tactile stimulation using MEG
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
source location, amplitude and waveform
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
pain by intra-epidermal electric stimulation
mechanical tactile stimulation
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers with written informed consent
Key exclusion criteria
1. history of neurological conditions or chronic pain.
2. current or prior history of traumatic events or surgery involving the right arm
3. on any medication
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shozo |
| Middle name | |
| Last name | Tobimatsu |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Clinical Neurophysiology
Zip code
8128582
Address
3-1-1, Maidashi, HIgashi-ku, Fukuoka, Japan
TEL
092-642-5541
tobi@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Hayamiu |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Clinical Neurophysiology
Zip code
8128582
Address
3-1-1, Maidashi, HIgashi-ku, Fukuoka, Japan
TEL
092-642-5541
Homepage URL
hayamizu@med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Clinical Neurophysiology, Neurological Institute, Faculty of Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid for Scientists from the Ministry of Education, Culture, Sports, Science, and Technology in Japan.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Ethical Comitte
Address
3-1-1 Maidashi Higashi-ku Fukuoka city Fukuoka
Tel
092-642-5774
byskenkyu@jimu.kyushu-u.ac.jp
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
九州大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S1053811916000951
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S1053811916000951
Number of participants that the trial has enrolled
11
Results
Source localization using minimum norm estimates demonstrated that pain-related activity was located in the posterior insula, whereas tactile-related activity was estimated in the parietal operculum. Significant inhibition of pain-related activity in the posterior insula due to cortical modulation. Spinal modulation was observed both in the posterior insula and parietal operculum. Subjective pain, as evaluated by the visual analog scale, also showed significant reduction in both conditions.
Results date posted
| 2022 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eleven healthy right-handed volunteers participated in this study. The subjects had no history of neurological conditions or chronic pain. They also had no current or prior history of traumatic events or surgery involving the right arm, and were not on any medication.
Participant flow
Written informed consent was obtained from all subjects.
Adverse events
None
Outcome measures
Brain activity related to noxious and tactile stimulation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 30 | Day |
Last modified on
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023089
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