UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040431 |
|---|---|
| Receipt number | R000046140 |
| Scientific Title | An exploratory study on optimal conditions for the effects of peripheral sensory nerve electrical stimulation on excitation of the corticospinal tract |
| Date of disclosure of the study information | 2020/05/18 |
| Last modified on | 2023/05/23 15:22:04 |
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Basic information
Public title
A study to examine the effect of electrical stimulation of sensory nerves in the arm on motor nerve excitation
Acronym
A study to examine the effect of electrical stimulation of sensory nerves in the arm on motor nerve excitation
Scientific Title
An exploratory study on optimal conditions for the effects of peripheral sensory nerve electrical stimulation on excitation of the corticospinal tract
Scientific Title:Acronym
An exploratory study on optimal conditions for the effects of peripheral sensory nerve electrical stimulation on excitation of the corticospinal tract
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the optimal conditions for the effects of peripheral sensory nerve electrical stimulation (PES) on corticospinal tract excitation in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor evoked potential ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
9
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical stimulation is performed by changing the stimulation conditions (frequency and stimulation time).
Three random conditions are selected out of nine combinations of frequency (1, 10, and 50 Hz) and stimulation time (20, 40, and 60 min) for every case.
Interventions/Control_2
Three random conditions are selected out of nine combinations of frequency (1, 10, and 50 Hz) and stimulation time (20, 40, and 60 min) for every case.
Interventions/Control_3
Three random conditions are selected out of nine combinations of frequency (1, 10, and 50 Hz) and stimulation time (20, 40, and 60 min) for every case.
Interventions/Control_4
Three random conditions are selected out of nine combinations of frequency (1, 10, and 50 Hz) and stimulation time (20, 40, and 60 min) for every case.
Interventions/Control_5
Three random conditions are selected out of nine combinations of frequency (1, 10, and 50 Hz) and stimulation time (20, 40, and 60 min) for every case.
Interventions/Control_6
Three random conditions are selected out of nine combinations of frequency (1, 10, and 50 Hz) and stimulation time (20, 40, and 60 min) for every case.
Interventions/Control_7
Three random conditions are selected out of nine combinations of frequency (1, 10, and 50 Hz) and stimulation time (20, 40, and 60 min) for every case.
Interventions/Control_8
Three random conditions are selected out of nine combinations of frequency (1, 10, and 50 Hz) and stimulation time (20, 40, and 60 min) for every case.
Interventions/Control_9
Three random conditions are selected out of nine combinations of frequency (1, 10, and 50 Hz) and stimulation time (20, 40, and 60 min) for every case.
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who gave voluntary written informed consent after receiving an adequate explanation regarding their participation in the study.
Key exclusion criteria
Left-handed person.
People with muscle weakness in the right upper limb (less than 4 with Manual Muscle Testing).
People with limited range of motion in the right upper limb.
People with sensory disorder and abnormal sensation in the right upper limb.
People who use a pacemaker.
People who have otherwise been determined to be ineligible as a subject by the principal investigator.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2405
hitmutai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2405
Homepage URL
hitmutai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
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
Shinshu University Medical Ethics Review Committee
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2020 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2076-3425/12/12/1637
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-3425/12/12/1637
Number of participants that the trial has enrolled
21
Results
Each participant experienced three different stimulation frequencies (1, 10 and 50 Hz) and durations (20, 40 and 60 min). The outcome measure was the change in primary motor cortex excitability using the MEP ratio. We defined the optimal combination within nine different settings inducing more satisfying responses. The combination of stimulation frequency and stimulation time that maximized the desirability value was 10 Hz and 40 min, respectively.
Results date posted
| 2023 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 29 | Day |
Baseline Characteristics
The participants included 21 healthy individuals (5 men and 16 women; mean age, standard deviation, 21.7, 0.6 years). The inclusion criteria were age > 18 years and right-handedness. Individuals with a history of neurological or orthopedic disorders were excluded.
Participant flow
Twenty-one participants experienced three different stimulus settings randomly decided in advance. No participants dropped out, and all participants were included in the analysis.
Adverse events
There were no adverse events.
Outcome measures
Motor evoked potential ratio
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 10 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046140
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