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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032499
Receipt No. 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 2018/05/07

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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
Middle name
Last name Yasuyuki Matsushima
Organization University of occupational and environmental health
Division name Department of rehabilitation medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku Kitakyushu
TEL 093-691-7266
Email y-matsu@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuyuki Matsushima
Organization University of occupational and environmental health
Division name Department of rehabilitation medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku Kitakyushu
TEL 093-691-7266
Homepage URL
Email y-matsu@med.uoeh-u.ac.jp

Sponsor
Institute University of occupational and environmental health
Institute
Department

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
Address
Tel
Email

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
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037067

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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