UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002464 |
|---|---|
| Receipt number | R000003016 |
| Scientific Title | Effect of the interception of the skin somatic sensations on the sensation of movement which is produced by the mechanical vibration to tendons. |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2010/05/21 16:55:54 |
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Basic information
Public title
Effect of the interception of the skin somatic sensations on the sensation of movement which is produced by the mechanical vibration to tendons.
Acronym
Illusion of motion sensation under local anesthesia
Scientific Title
Effect of the interception of the skin somatic sensations on the sensation of movement which is produced by the mechanical vibration to tendons.
Scientific Title:Acronym
Illusion of motion sensation under local anesthesia
Region
| Japan |
Condition
Condition
amputee of upper limb(s)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An artificial limb system which patients (who equipped with the system) is able to move voluntarily exactly as the intend will significantly increase their "Quality of Life".
In order to develop such an artificial limb system, feedback of motion sensation from the artificial limb system to the patient is essential.
It has been reported that stimulation of muscle spindles by giving mechanical vibration to the tendon transcutaneously induces illusions of movement (Goodwin et al. 1972; Roll et al. 1982; Collins et al. 1996). We also succeeded in evoking illusory sensation of arm movements by stimulation to muscle spindles. However, evoked illusions are limited to slow ones, and moreover, sometimes failed to evoke such illusory sensation.
It is suspected that activities of cutaneous mechanoreceptors by the vibration have some relation with this phenomena, and therefore, in these experiments, we try to block the effect of cutaneous mechanoreceptors by local anesthesia so that the relationship between the activation of muscle spindles and movement sensation should be evaluated properly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Velocity of the illusory movement which is evoked by giving vibration to the concerned tendon is to be evaluated. (Changes in the mean value and the standard deviation with respect to condition of tendon vibration are investigated.)
Ratio of the number of cases in which illusion of arm movement is evoked by the tendon vibration to that of the total trials is also to be studied.
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
First, tendons are vibrated mechanically by a vibrator under the conditions that cutaneous mechanoreceptors are not blocked.
Then local anesthetic agent (Carbocaine (1%):not more than 2ml) is injected subcutaneously so that cutaneous mechanoreceptors are anesthetized but muscle spindles are not anesthetized, and tendons are again vibrated mechanically under the conditions that cutaneous mechanoreceptors are inhibited.
The experiment is conducted once or twice per each subject, and if a subject joins the experiment twice, an interval from a week to a month is taken between each experiments. Injection of anesthesic agent is restricted to once at a experiment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To have been injected anesthetics and have neither had an allergic nor anaphylactic reactions
Key exclusion criteria
-Having a disease or disorder of motor function of the upper limb
-To have experienced allergic and/or anaphylactic reactions by the injection of local anesthetics
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiko Mabuchi |
Organization
Graduate School of Information Science and Technology,
The University of Tokyo
Division name
Dept. Information Physics and Computing, Graduate School of Information Science and Technology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8656 Japan
TEL
03-5841-6880
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiko Mabuchi |
Organization
Graduate School of Information Science and Technology, The University of Tokyo
Division name
Dept. Information Physics and Computing, Graduate School of Information Science and Technology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8656 Japan
TEL
03-5841-6880
Homepage URL
Kunihiko_Mabuchi@ipc.i.u-tokyo.ac.jp
Sponsor or person
Institute
7th Laboratory, Department of Information Physics and Computing, Graduate School of Information Science and Technology, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
Ministry of Health Labour and Welfare
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 07 | Day |
Last modified on
| 2010 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003016
