UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061640 |
|---|---|
| Receipt number | R000070505 |
| Scientific Title | The effects of vibration-based rehabilitation interventions on brain activity and sensory function for neuropathic pain after spinal cord injury |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/05/20 14:04:25 |
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Basic information
Public title
The effects of vibration-based rehabilitation interventions on brain activity and sensory function for neuropathic pain after spinal cord injury
Acronym
The effects of vibration-based rehabilitation interventions on brain activity and sensory function for neuropathic pain after spinal cord injury
Scientific Title
The effects of vibration-based rehabilitation interventions on brain activity and sensory function for neuropathic pain after spinal cord injury
Scientific Title:Acronym
The effects of vibration-based rehabilitation interventions on brain activity and sensory function for neuropathic pain after spinal cord injury
Region
| Japan |
Condition
Condition
healthy person
patients with neuropathic pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By verifying the effectiveness of rehabilitation interventions using vibration stimulation and clarifying the relationship between sensory function recovery and changes in brain activity, we aim to obtain insights that will contribute to establishing effective rehabilitation approaches for neuropathic pain after spinal cord injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
healthy patient
Electroencephalography (EEG) is used as a physiological evaluation to detect EEG activity related to pain during vibration stimulation.
Electroencephalogram (EEG) measurements will be taken at four points in time: before intervention (upon admission) while the subject is at rest with their eyes closed, during the intervention period (while vibration stimulation is being administered) for 10 minutes, immediately after the intervention ends for the same 2 minutes as before the intervention, and during follow-up (one week after the start of the intervention).
Key secondary outcomes
Patients with neuropathic pain
Pain assessment: The Numerical Rating Scale (NRS) is taken orally upon admission and daily before and after vibration stimulation intervention.
In addition, the Short form McGill Pain Questionnaire 2 (SFMPQ2), Pain Catastrophizing Scale (PCS), Neuropathic Pain Symptom Inventory (NPSI), Hamilton Depression Rating Scale (HDRS), SFMPQ2, PCS, NPSI, and HDRS are assessed on paper upon admission and at the end of the one-week intervention period.
Electroencephalography (EEG) is used for physiological assessment to detect EEG activity related to pain during vibration stimulation.
EEG measurements are taken at four time points: 2 minutes at rest with eyes closed before intervention (admission), 10 minutes during the intervention period (during vibration stimulation), 2 minutes immediately after the end of the intervention (same as before), and at follow-up (one week after the start of the intervention).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electroencephalography (EEG) is used for physiological evaluation to detect pain-related EEG activity.
In healthy subjects, vibration stimulation intervention is performed 6-7 times per week for one week within the framework of standard rehabilitation using a customized vibration stimulation device.
Interventions/Control_2
Physiological evaluation is performed using electroencephalography (EEG) to detect pain-related EEG activity.
In patients with neuropathic pain, vibration stimulation intervention is performed 6-7 times per week for one week within the framework of regular rehabilitation using a customized vibration stimulation device. The vibration stimulation site is basically the index and middle finger pads on the side where neuropathic pain is not present (or the side with less pain subjectively if it occurs bilaterally), and is applied for 10 minutes. The stimulation intensity is 10Hz, 20Hz, or a frequency that the patient finds comfortable.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy patients
patients with neuropathic pain
Key exclusion criteria
healthy patients
1.Individuals lacking the capacity to give voluntary consent.
2.Individuals for whom written research consent cannot be obtained.
3.Individuals without neurological or mental disorders or chronic pain.
4.Individuals who have taken analgesics within 12 hours of the experiment.
Patients with neuropathic pain
1.Individuals lacking the capacity to give voluntary consent.
2.Individuals for whom written research consent cannot be obtained.
3.Individuals with severe cognitive impairment, comorbid mental illness, or severe complications that would affect the conduct of the research.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Niizato |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
f6940298@kio.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Niizato |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
f6940298@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio 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
Kio University
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
Tel
0745-54-1601
f6940298@kio.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
| 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 | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | 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 | 05 | Month | 20 | Day |
Last modified on
| 2026 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070505
