UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052245 |
|---|---|
| Receipt number | R000059638 |
| Scientific Title | Motor tempo tuning via personalized alpha-burst non-invasive brain stimulation |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2023/09/19 18:11:54 |
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Basic information
Public title
Motor tempo tuning via personalized alpha-burst non-invasive brain stimulation
Acronym
rTMS and motor tempo
Scientific Title
Motor tempo tuning via personalized alpha-burst non-invasive brain stimulation
Scientific Title:Acronym
Motor tempo tuning via personalized alpha-burst non-invasive brain stimulation
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a transcranial magnetic stimulation (TMS) device that non-invasively delivers electrical stimulation to the brain through the use of pulsed magnetic fields, different frequencies of pulsed magnetic stimulation are applied to the brain cortex. The objective is to observe the impact of magnetic stimulation in different frequencies on alpha-band brainwaves, which represents motor rhythms and brain oscillator rhythms. This aims to clarify whether magnetic stimulation can be used to control motor ability and motor learning.
Basic objectives2
Others
Basic objectives -Others
Humans naturally possess a inherent pace and tempo in their everyday actions, such as walking and speaking, and they spontaneously adjust this tempo in response to the constantly changing environment around them. This variability is thought to be influenced by the active control exerted by the brain's rhythm generation mechanism (neural oscillators) in response to various stimuli..
Therefore, in this study, we deliver different frequencies of repetitive transcranial pulse magnetic stimulation (rTMS) on to the brain. The stimulation will be applied to cortical regions suggested to be associated with the control of brain oscillators, and observe the impact on alpha-band brainwaves, which represent motor rhythms and brain oscillator rhythms. The objective is to elucidate whether specific rhythm of magnetic stimulation may modify motor abilities and motor learning.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Finger tapping speed, tempo and stability.
Key secondary outcomes
EEG
1) alpha power
2) alpha associated coherence of different cortical regions
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Prior to the examination, structural brain data will be obtained by MRI. The intervention involves four rTMS conditions, including sham stimulation, applied to the dorsolateral prefrontal cortex using a neuronavigation system while maintaining a seated position. The four conditions were as follows: 1) 1Hz, 2) tapping-specific rhythm, 3) 10Hz, and 4) Sham stimulation, each lasting for 20 minutes (continuous for 1Hz, and 20 seconds every 1 second for 2-4). The study will be conducted as a within-subject trial, with one condition per day and a random allocation of conditions within each week.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy adult
2. Right handed
Key exclusion criteria
1) Individuals who have proximity to metallic objects near the stimulation site (such as cochlear implants, magnetic clips, deep brain stimulation or vagus nerve stimulation devices) or are using a cardiac pacemaker.
2) Individuals with implanted medical devices containing metal (such as internally implanted drug pumps, those using metal stents or bone replacement devices made of materials like titanium within the skull, or individuals with metal-containing dentures or implants).
3) Individuals who have a history of epilepsy or seizures.
4) Individuals taking medications that may increase the risk of seizures (such as tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, clozapine, zotepine, etc.).
5) Individuals with alcohol dependence or caffeine dependence.
6) Pregnant individuals or those with severe underlying medical conditions.
7) Individuals with upper limb (hand or arm) motor impairments.
8) Individuals taking the following medications:
(a) Medications to relieve symptoms such as fever, headache, or cough (anti-inflammatory pain relievers, cough suppressants, over-the-counter cold remedies, etc.).
(b) Medications to alleviate nasal congestion or allergy symptoms.
9)Individuals with poor health or feeling unwell on the day of the examination
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
Homepage URL
nagatomi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Ryoichi Nagatomi
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Hospital
Address
Seiryo 1-1, Aoba-ku, Sendai, Japan
Tel
022-728-3965
ec@rinri.hosp.tohoku.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
| 2023 | Year | 09 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059638
