UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061342 |
|---|---|
| Receipt number | R000070187 |
| Scientific Title | Exploratory study on the neuromodulatory effects of transcutaneous vagus nerve stimulation and repetitive peripheral magnetic stimulation on upper extremity function in patients with cervical spinal cord injury |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/16 15:16:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Ear and magnetic stimulation therapy for hand paralysis in spinal cord injury
Acronym
tVNS-rPMS study
Scientific Title
Exploratory study on the neuromodulatory effects of transcutaneous vagus nerve stimulation and repetitive peripheral magnetic stimulation on upper extremity function in patients with cervical spinal cord injury
Scientific Title:Acronym
tVNS-rPMS OT
Region
| Japan |
Condition
Condition
cervical spinal cord injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy and safety of occupational therapy combined with tVNS and rPMS on cervical spinal cord injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment for Upper Extremity scores
Key secondary outcomes
Motor activity log, grip strength and pinch strength, clinical apathy scale, arousal level monitoring(heart rate, skin conductance), upper extremity motor score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
rPMS and tVNS
Interventions/Control_2
Standard occupational therapy
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Aged 20 years or older and less than 85 years
2)Within 1 month of injury onset
3)ASIA impairment scale A-C and severe key muscles disabilities of upper extremity correspond to MMT 1-2/5
4)JCS level I
5)Patients with no cognitive impairment (Mini-Mental State Examination [MMSE] > 24) who provide written informed consent voluntarily based on a full understanding of the study after receiving a detailed explanation regarding participation.
6)Stable physical state, and normal blood pressure
7)No fracture of target extremities
Key exclusion criteria
1)Metallic implants in the body (including pacemakers, etc.)
2)Severe cardiac disease (myocardial infarction, angina pectoris, valvular disease, arrhythmia, etc.)
3)History of epilepsy
4)Pregnant or may be pregnant
5)Psychiatric or neurological disorders, or unstable general condition
6)Individuals who did not provide written informed consent or who withdrew consent
7)Individuals deemed unsuitable for the study by the principal investigator
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Anazawa |
Organization
Saitama medical center Saitama medical university
Division name
department of rehabilitation medicine
Zip code
350-8550
Address
1981 kamoda kawagoe-city, saitama, Japan
TEL
049-228-3529
anzwt@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Anazawa |
Organization
Saitama medical center Saitama medical university
Division name
department of rehabilitation medicine
Zip code
350-8550
Address
1981 kamoda kawagoe-city, saitama, Japan
TEL
049-228-3529
Homepage URL
anzwt@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama medical center Saitama medical university
Address
1981 kamoda kawagoe-city, saitama, Japan
Tel
049-228-3529
anzwt@saitama-med.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
埼玉医科大学総合医療センター(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 01 | 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
| 2026 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070187
