UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008508 |
|---|---|
| Receipt number | R000009997 |
| Scientific Title | Exploratory research of the effect of single dose of medication on the motor cortical excitability induced by repetitive transcranial magnetic stimulation in healthy volunteers |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2023/08/01 14:00:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory research of the effect of single dose of medication on the motor cortical excitability induced by repetitive transcranial magnetic stimulation in healthy volunteers
Acronym
Effects of single dose medicine on cortical excitability
Scientific Title
Exploratory research of the effect of single dose of medication on the motor cortical excitability induced by repetitive transcranial magnetic stimulation in healthy volunteers
Scientific Title:Acronym
Effects of single dose medicine on cortical excitability
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of medication on plastic changes in the motor cortex elicited by quadri-pulse transcranial magnetic stimulation in healthy volunteers
Basic objectives2
Others
Basic objectives -Others
To elucidate the pathophysiological mechanisms of neurodegenerative disorders in terms of the cortical excitability induced by repetitive TMS
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Amplitude of the motor evoked potentials(MEP)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Effects of single dose LDOPA/Carbidopa or zonisamide on neural plasticity
Participants come three times separated by 1-4 weeks and are assigned to one medicine randomly chosen among LDOPA/Carbidopa, zonisamide or placebo at one time. After 2 hours, transmagnetic stimulation (TMS) study starts. Before, quadripulse magnetic stimulation (QPS) for 30 min, MEPs are measured as the baseline activity. MEPs are also measured after QPS for 1hours to evaluate cortical excitability change.
Interventions/Control_2
Comparison of effects by LDOPA/Carbidopa pulse zonisamide with those of LDOPA/Carbidopa pulse placebo.
This study is performed on two separate days.
Participants take the two medicines in random order. A TMS study Similar to Trial 1 is performed.
Interventions/Control_3
Effects of single dose LDOPA/Carbidopa or caffeine.
Participants take one medicine of LDOPA/Carbidopa, caffeine or placebo each day. Similar TMS study is performed to Trial 1.
Interventions/Control_4
Comparison of effects by LDOPA/Carbidopa pulse caffeine from those of LDOPA/Carbidopa pulse placebo.
This study consists of two separate days.
Participants take the two medicines in random order. Similar TMS study is performed to Trial 1.
Interventions/Control_5
Comparison of effects by LDOPA/Carbidopa with those by placebo.
This study is performed on two separate days.
Participants take the two medicines in random order. A TMS study Similar to Trial 1 is performed.
Interventions/Control_6
Comparison of effects by LDOPA/Carbidopa (100mg) with those of placebo.
This study is performed on two separate days.
A TMS study Similar to Trial 2 is performed.
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
Healthy adult volunteers from whom we obtained informed consent
Key exclusion criteria
In case of gastric ulcer, duodenum ulcer, internal metal such as cardiac pace maker, drug delivery pump or DBS, severe cardiac disease, hepatic disease, renal disease, pulmonary disease, ileus, bronchial asthma, uncontrolled diabetic mellitus, chronic open angle glaucoma, cerebral stroke, brain injury, brain tumor, epilepsy, psychiatric disorder, pregnant females, or those contemplating pregnancy. And people whom the investigators evaluate as approved.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Ritsuko |
| Middle name | |
| Last name | Hanajima |
Organization
University of Tokyo Hospital
Division name
Neurology
Zip code
113
Address
7-3-1 Hongo, Bunkyo-ku
TEL
03-3815-5411
hanajima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ritsuko |
| Middle name | |
| Last name | Hanajima |
Organization
University of Tokyo Hospital
Division name
Neurology
Zip code
1138655
Address
-3-1 Hongo, Bunkyo-ku
TEL
03-3815-5411
Homepage URL
hanajima-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
neurology
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tokyo
Address
Hongo, Bubkyoku
Tel
03-3815-5411
hsatonak-tky@umin.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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000008508
Publication of results
Published
Result
URL related to results and publications
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000008508
Number of participants that the trial has enrolled
64
Results
Zonizamide enhanced LTP in non-responders.
Results date posted
| 2023 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy volunteers
Participant flow
We requit healthy volinteers. They came to the hospital twice with targeted drug and placebo intakes.
Adverse events
none
Outcome measures
size of MEP
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009997
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
