UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032499 |
|---|---|
| Receipt number | R000037067 |
| Scientific Title | Effects of transcranial direct current stimulation for patients with post-polio syndrome |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2023/05/16 12:56:33 |
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Basic information
Public title
Effects of transcranial direct current stimulation for patients with post-polio syndrome
Acronym
Transcranial direct current stimulation for patients with post-polio syndrome
Scientific Title
Effects of transcranial direct current stimulation for patients with post-polio syndrome
Scientific Title:Acronym
Transcranial direct current stimulation for patients with post-polio syndrome
Region
| Japan |
Condition
Condition
post-polio syndrome
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study will be to examine the effects of transcranial direct current stimulation (tDCS) for patients with post-polio syndrome (PPS), and to clarify the influence of the brain-derived neurotrophic factor (BDNF) Val66Met polymorphism on the effects of tDCS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the difference in the Multidimensional Fatigue Inventory after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Anodal tDCS over pre-motor areas will be applied with a 2-mA current for 20 min/session for 2 weeks, over 10 sessions
Interventions/Control_2
Sham stimulation over pre-motor areas will be applied for 20 min/session for 2 weeks, over 10 sessions
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Prior paralytic poliomyelitis with evidence of motor neuron loss, as confirmed by history of the acute paralytic illness, signs of residual weakness and atrophy of muscles on neurological examination.
2. A period of partial or complete functional recovery after acute poliomyelitis, followed by an interval (usually 15 years or more) of stable neurological function.
3. Gradual or sudden onset of progressive and persistent new muscle weakness or abnormal fatigability (decreased endurance), with or without generalized fatigue, muscle atrophy, or muscle and joint pain (Sudden onset may follow a period of inactivity, or trauma or surgery). Less commonly, symptoms attribute to post-polio syndrome include new problems with breathing or swallowing.
4. Symptoms persist for at least a year.
5. Exclusion of other neurological, medical, and orthopaedic problems as cause of symptoms.
Key exclusion criteria
History of epilepsy, use of anticonvulsant, implantation of metal device intracranially
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Matsushima |
Organization
University of occupational and environmental health
Division name
Department of rehabilitation medicine
Zip code
8088555
Address
1-1 Iseigaoka, Yahatanishi-ku Kitakyushu
TEL
093-691-7266
y-matsu@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Matsushima |
Organization
University of occupational and environmental health
Division name
Department of rehabilitation medicine
Zip code
8088555
Address
1-1 Iseigaoka, Yahatanishi-ku Kitakyushu
TEL
093-691-7266
Homepage URL
y-matsu@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of occupational and environmental health
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI, MEXT(Japan)
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
Clinical Research Review Board, University of Occupational and Environmental Health, Japan
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, Fukuoka, Japan
Tel
093-691-7127
rinshokenkyu@mbox.clnc.uoeh-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
| 2018 | Year | 05 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037067
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| Registered date | File name |
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