UMIN-CTR Clinical Trial

Basic information
Public title	The combined effects of motor imagery in lower extremity and peripheral nerve electrical stimulation on neural plasticity
Acronym	The combined effects of motor imagery and electrical stimulation
Scientific Title	The combined effects of motor imagery in lower extremity and peripheral nerve electrical stimulation on neural plasticity
Scientific Title:Acronym	The combined effects of motor imagery and electrical stimulation
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of motor imagery combined with peripheral nerve electrical stimulation on corticospinal excitability and spinal reciprocal inhibition
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Motor evoked potential, spinal reciprocal inhibition
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Motor imagery alone (20 minutes)
Interventions/Control_2	Electrical stimulation alone (20 minutes)
Interventions/Control_3	Motor imagery combined with electrical stimulation (20 minutes)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Agreement to participate in the study
Key exclusion criteria	1. Medical history of orthopedic disease of leg 2. Medical history of neurological disease 3. Implanted electronic pacing or defibrillation devices 4. Medical history of epilepsy and febrile convulsion (including family history)
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Yoko Middle name Last name Takahashi
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Department of Rehabilitation
Zip code	275-0026
Address	4-1-1 Yatsu, Narashino-shi, Chiba
TEL	047-453-9000
Email	matsuda_y@a6.keio.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Takahashi
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Department of Rehabilitation
Zip code	275-0026
Address	4-1-1 Yatsu, Narashino-shi, Chiba
TEL	047-453-9000
Homepage URL
Email	matsuda_y@a6.keio.jp

Sponsor
Institute	Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	Tokyo Bay Rehabilitation Hospital
Address	4-1-1 Yatsu, Narashino-shi, Chiba
Tel	0474539000
Email	matsuda_y@a6.keio.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	2017 Year 07 Month 05 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	17
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 02 Month 21 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 05 Day
Date of IRB	2017 Year 07 Month 05 Day
Anticipated trial start date	2017 Year 07 Month 05 Day
Last follow-up date	2019 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 05 Day
Last modified on	2020 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032152