UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052351 |
|---|---|
| Receipt number | R000059765 |
| Scientific Title | Investigation of rehabilitation for the dysesthesias by peripheral and central neuropathy |
| Date of disclosure of the study information | 2023/09/29 |
| Last modified on | 2023/09/29 13:18:07 |
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Basic information
Public title
Investigation of rehabilitation for the dysesthesias by peripheral and central neuropathy
Acronym
Investigation of rehabilitation for the dysesthesias by peripheral and central neuropathy
Scientific Title
Investigation of rehabilitation for the dysesthesias by peripheral and central neuropathy
Scientific Title:Acronym
Investigation of rehabilitation for the dysesthesias by peripheral and central neuropathy
Region
| Japan |
Condition
Condition
Peripheral neuropathy including diabetic neuropathy, brachial plexus palsy, Chemotherapy-induced peripheral neuropathy
Central neuropathy including multiple sclerosis, spinal cord injury, cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Short- and long-term intervention effects of dysesthesia-matched transcutaneous electrical nerve stimulation for the dysesthesias caused by peripheral and central neuropathies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS of the dysesthesias
Key secondary outcomes
NRS of the allodynia, Neuropathic pain symptom inventory, Quantitative Sensory Test, SSEP
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Dysesthesia-matched TENS, the stimulus intensity and the frequency of TENS are set to match the intensity and the somatosensory profile of the dysesthesias
1 hour intervention
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The NRS of the dysesthesias >= 3,
Key exclusion criteria
Patients with difficulty in understanding and performing tasks, patients with higher brain dysfunction, patients with recurrent or concurrent central or peripheral neurological disorders, patients with upper limb musculoskeletal disorders, and patients with implanted electrodes such as pacemakers.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nishi |
Organization
Nagasaki university
Division name
Biomedical Sciences (Health Sciences)
Zip code
852-8520
Address
1-7-1,sakamoto,nagasaki
TEL
095-819-7900
ynishi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nishi |
Organization
Nagasaki university
Division name
Biomedical Sciences (Health Sciences)
Zip code
852-8520
Address
1-7-1,sakamoto,nagasaki
TEL
095-819-7900
Homepage URL
ynishi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university
Institute
Department
Personal name
Funding Source
Organization
KAKENHI, JSPS
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
Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee.
Address
1-7-1,sakamoto,nagasaki
Tel
095-819-7900
ynishi@nagasaki-u.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
| 2023 | Year | 09 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 09 | Month | 29 | Day |
Last modified on
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059765
