UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014159 |
|---|---|
| Receipt number | R000016487 |
| Scientific Title | Effect of repetitive trans-spinal magnetic stimulation on Parkinson disease |
| Date of disclosure of the study information | 2014/06/05 |
| Last modified on | 2021/08/23 15:27:38 |
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Basic information
Public title
Effect of repetitive trans-spinal magnetic stimulation on Parkinson disease
Acronym
Effect of rTSMS on Parkinson disease
Scientific Title
Effect of repetitive trans-spinal magnetic stimulation on Parkinson disease
Scientific Title:Acronym
Effect of rTSMS on Parkinson disease
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assessed the benefits of repetitive trans-spinal magnetic stimulation (rTSMS) on motor/mental function and postural abnormality in patients with Parkinson disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
UPDRS
Key secondary outcomes
Walking time, TUG, FAB, MMSE, Thoracolumber spine flexion angle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients were allocated to rTSMS group. PD patients were treated with rTSMS (a train of 40 stimuli) twice a week for 4 weeks.
Interventions/Control_2
Patients were allocated to sham group. PD patients were treated with sham stimulation (a train of 40 stimuli) twice a week for 4 weeks.
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria included a clinical diagnosis of PD with a disease severity rating of stage 3 to 4 on the Hoehn and Yahr scale,stable medication use, medical clearance for participation, and willingness to participate in treatment and outcome testing.
Key exclusion criteria
Exclusion criteria were current participation in any other behavioral or pharmacologic study or debilitating conditions that would impede full participation.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Mitsui |
Organization
Tokushima National Hospital, National Hospital Organization
Division name
Department of Clinical Research
Zip code
Address
1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031 Japan
TEL
0883-24-2161
tmitsui@tokushima.-nh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayaka Miyake |
Organization
Tokushima National Hospital, National Hospital Organization
Division name
Department of Clinical Research
Zip code
Address
1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031 Japan
TEL
0883-24-2161
Homepage URL
http://www.hosp.go.jp/~tokusimahosp-nho/profession/cnt0_000071.html
rinsyou@tokushima.-nh.hosp.go.jp
Sponsor or person
Institute
Department of Clinical Research, Tokushima National Hospital, National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
http://www.hosp.go.jp/~tokusimahosp-nho/profession/cnt0_000071.html
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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 04 | Day |
Last modified on
| 2021 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016487
