UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049531 |
|---|---|
| Receipt number | R000056399 |
| Scientific Title | Effects of transcranial random noise stimulation on the cerebellum on motor learning and brain activity. |
| Date of disclosure of the study information | 2022/11/25 |
| Last modified on | 2024/11/17 18:32:48 |
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Basic information
Public title
Effects of transcranial random noise stimulation on the cerebellum on motor learning and brain activity.
Acronym
Effects of transcranial random noise stimulation on the cerebellum on motor learning and brain activity.
Scientific Title
Effects of transcranial random noise stimulation on the cerebellum on motor learning and brain activity.
Scientific Title:Acronym
Effects of transcranial random noise stimulation on the cerebellum on motor learning and brain activity.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effects of transcranial random noise stimulation on the cerebellum on motor learning and brain activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The performance of the visual tracking task is assessed before and during the intervention.
Key secondary outcomes
The Motor evoked potentials ane Cerebellar brain inhibition are measured before and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The condition is transcranial random noise stimulation on the cerebellum at 1 mA for 20 minutes.
Interventions/Control_2
This is sham stimulation, the transcranial random stimulation on the cerebellum for 30 seconds.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have an interest in this research and voluntarily apply to participate in it
Key exclusion criteria
Persons with a history of neurological or psychiatric disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Saki |
| Middle name | |
| Last name | Kawakami |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
hwd22005@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Kawakami |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
Homepage URL
hwd22005@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
Tel
025-257-4455
rinri@nuhw.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.bbr.2024.115209
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.bbr.2024.115209
Number of participants that the trial has enrolled
34
Results
Transcranial random noise stimulation (tRNS) to the cerebellum did not alter cerebellar brain inhibition and affect motor learning.
Results date posted
| 2024 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 10 | Month | 18 | Day |
Baseline Characteristics
The 34 subjects age 21.7 1.0 years 17 females and 17 males participated in the study.
No participant had a history of neurological or psychiatric disorders were taking any medication or had any metal on their head.
Participant flow
This study employed a randomized, single-blind, Sham-controlled experimental design, and subjects were assigned to either the tRNS group or the Sham group (17 participants each).
Adverse events
none
Outcome measures
For motor learning, a visual tracking task using isometric contraction of the index finger was performed.
One set consisted of 10 trials, and one set was performed in each of the early and the late stage.
The motor learning rate in the early state, late stage, and overall was calculated.
Cerebellar Brain Inhibition (CBI) and Motor Evoked Potentials (MEP) were evaluated using transcranial magnetic stimulation (TMS) at baseline, after early learning stage, and after late learning stage.
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 31 | Day |
Other
Other related information
The paper on this research is being submitted to an international journal. Additional experiments may be conducted.
This study was terminated because it was accepted for publication in an international journal.
Management information
Registered date
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2024 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056399
