UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041690 |
|---|---|
| Receipt number | R000047550 |
| Scientific Title | Effects of stimulation frequency in peripheral nerve stimulation on the primary motor cortex excitability in healthy subjects: a crossover randomized controlled trial |
| Date of disclosure of the study information | 2020/09/05 |
| Last modified on | 2022/03/14 18:12:41 |
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Basic information
Public title
Effects of stimulation frequency in peripheral nerve stimulation on the primary motor cortex excitability in healthy subjects: a crossover randomized controlled trial
Acronym
Effects of stimulation frequency in peripheral nerve stimulation on the primary motor cortex excitability in healthy subjects: a crossover randomized controlled trial
Scientific Title
Effects of stimulation frequency in peripheral nerve stimulation on the primary motor cortex excitability in healthy subjects: a crossover randomized controlled trial
Scientific Title:Acronym
Effects of stimulation frequency in peripheral nerve stimulation on the primary motor cortex excitability in healthy subjects: a crossover randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether stimulation at a frequency of 100 Hz in peripheral electrical stimulation above the sensory threshold can increase the primary motor cortex's excitability earlier than at a frequency of 10 Hz.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor evoked potentials before stimulation, at 15, 30, 45, 60, 65, 70, and 75 minutes after stimulation
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
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Peripheral electrical stimulation
Frequency: 100 Hz
Intensity: above sensory threshold
Pulse width: 250 microsecond
Stimulation time: 60 minutes
Interventions/Control_2
Peripheral electrical stimulation
Frequency: 10 Hz
Intensity: above sensory threshold
Pulse width: 250 microsecond
Stimulation time: 60 minutes
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
1) Age: from 20 to 60 years old
2) Obtaining agreement to this study
Key exclusion criteria
1) A history of orthopedic disease
2) A history of neurological diseases
3) Contraindicated to transcranial magnetic stimulation
4) Contraindications to peripheral electrical stimulation
5) Persons are deemed unsuitable by researchers or physicians
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kubo |
Organization
Tokai university hospital
Division name
Department of rehabilitation services
Zip code
259-1193
Address
143 Shimokasuya, Isehara city, KANAGAWA
TEL
0463-93-1121
d.bokukubo@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kubo |
Organization
Tokai university hospital
Division name
Department of rehabilitation services
Zip code
259-1193
Address
143 Shimokasuya, Isehara city, KANAGAWA
TEL
0463-93-1121
Homepage URL
d.bokukubo@tokai.ac.jp
Sponsor or person
Institute
Tokai university hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara city, KANAGAWA
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
| 2020 | Year | 09 | Month | 05 | 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
13
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
| 2019 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 04 | Day |
Last modified on
| 2022 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047550
