UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058559 |
|---|---|
| Receipt number | R000066958 |
| Scientific Title | Experimental Study of Sensory and Motor Modulation Using Non-invasive Electrical Stimulation to Recover Spinal Cord Function |
| Date of disclosure of the study information | 2025/07/23 |
| Last modified on | 2025/07/23 11:55:28 |
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Basic information
Public title
Experimental Study of Sensory and Motor Modulation Using Non-invasive Electrical Stimulation to Recover Spinal Cord Function
Acronym
NIES SC study
Scientific Title
Experimental Study of Sensory and Motor Modulation Using Non-invasive Electrical Stimulation to Recover Spinal Cord Function
Scientific Title:Acronym
NIES SC study
Region
| Japan |
Condition
Condition
Healthy
Spinal Cord Injury
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Transcutaneous spinal cord stimulation (tSCS) applied alone has been shown to increase motor evoked potential (MEP) amplitude, suggesting it enhances corticospinal tract excitability. high-frequency paired associative stimulation (h-PAS), which synchronizes transcranial magnetic stimulation (TMS) with high-frequency peripheral stimulation, is believed to promote neural reorganization by precisely timing the stimulation of motor pathways from the brain to the periphery.
This study aims to compare the effects of tSCS and h-PAS on physiological motor and sensory changes and on limb motor performance (muscle strength and dexterity) in healthy participants and individuals with spinal cord injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
EEG, EMG
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
After setting the stimulation intensity beforehand, we will apply electrical stimulation to the cervical region using transcutaneous spinal cord stimulation (tSCS), and measure electroencephalography (EEG) and electromyography (EMG) before and after the intervention.
Interventions/Control_2
After setting the stimulation intensity beforehand, we will apply electrical stimulation to the cervical region using high-frequency paired associative stimulation (h-PAS), and measure electroencephalography (EEG) and electromyography (EMG) before and after the intervention.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria for Individuals with Spinal Cord Injury
Participants must have obtained permission from their attending physician to receive the electrical stimulation intervention.
Key exclusion criteria
a) Presence of metallic implants in the body (excluding titanium).
b) Presence of implanted electronic or metallic devices, such as a pacemaker.
c) History of epileptic seizures.
d) Current or suspected pregnancy.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Rieko |
| Middle name | |
| Last name | Osu |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1165
Address
210, Frontier Research Center, 135-1, Horinouchi, Tokorozawa, Saitama
TEL
04-2947-7346
r.osu@waseda.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ito |
Organization
Waseda University
Division name
Graduate School of Human Sciences
Zip code
359-1165
Address
210, Frontier Research Center, 135-1, Horinouchi, Tokorozawa, Saitama
TEL
04-2947-7346
Homepage URL
y.ito@moegi.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Waseda University, Ethics Review Procedures concerning Research with Human Subjects
Address
1-104, Totsuka-chou, shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-165
Org. issuing International ID_1
Waseda University, Ethics Review Procedures concerning Research with Human Subjects
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 23 | 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
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 05 | 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
| 2025 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066958
