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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027324
Receipt No. R000031307
Scientific Title Nagoya City University
Date of disclosure of the study information 2017/05/15
Last modified on 2017/05/12

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Basic information
Public title Nagoya City University
Acronym Non-invasive closed-circuit brain stimulation for gait rehabilitation:
Clinical application of oscillology in Parkinson patients
Scientific Title Nagoya City University
Scientific Title:Acronym Non-invasive closed-circuit brain stimulation for gait rehabilitation:
Clinical application of oscillology in Parkinson patients
Region
Japan

Condition
Condition Parkinsonian syndrome
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Patients with Parkinson disease show disturbance of gait such as freezing of gait, festination and shuffling gait. Although they are performed by dopamine replacement therapy, the effect for these gait disorder is limited. Furthermore, the usefulness of rehabilitative therapy has not been sufficiently verified. In recent years, non-invasive brain stimulation methods have been reported to modify brain oscillations and clinically applied in rehabilitation field. Our study was aimed to develop a new rehabilitative method for disturbance of gait in patients with Parkinson disease, which was walking training with transcranial alternating current stimulation (tACS) that it matches the optimum walking rhythm (frequency) of individual patients.
Basic objectives2 Others
Basic objectives -Others effectiveness of new gait rehabilitaion
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes speed during 10m gait
Key secondary outcomes motor function
cortical excitability by TMS
functional connectivity by fMRI
neurophysiological evaluation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 gait rehabilitation with tACS
Interventions/Control_2 gait rehabilitation with sham stimulation
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. diagnosed as Parkinson disease or Parkinsonian syndrome
2. age 40-60
3. normal communication
Key exclusion criteria 1. with other neuropsychological disorders
2. with intracranial clip
3. with pacemaker
4. with epilepsy
5. operation of spine
6. AMI, angina, hypertention, DM, DVT and chronic pulmonary disorders
7. with neurostimulation device, clip, insulin pomp, stent and so on
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuo Wada
Organization Nagoya city university
Division name rehabilitation medicine
Zip code
Address 1, Kawasumi, Mizuho-cho, Mizuho-ku
TEL 052-853-8733
Email i.wada@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshino Ueki
Organization Nagoya city university
Division name rehabilitation medicine
Zip code
Address 1, Kawasumi, Mizuho-cho, Mizuho-ku
TEL 052-853-8733
Homepage URL
Email yueki@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya city university, Department of rehabilitation medicine
Institute
Department

Funding Source
Organization Nagoya city university, Department of rehabilitation medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2017 Year 05 Month 15 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
2016 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 10 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 12 Day
Last modified on
2017 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031307

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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