UMIN-CTR Clinical Trial

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
Email	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
Email	d.bokukubo@tokai.ac.jp

Sponsor
Institute	Tokai university hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047550