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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011495
Receipt No. R000013450
Scientific Title Effect of spinal magnetic stimulation on camptocormia in Parkinson disease
Date of disclosure of the study information 2013/08/16
Last modified on 2017/06/07

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Basic information
Public title Effect of spinal magnetic stimulation on camptocormia in Parkinson disease
Acronym Effect of spinal magnetic stimulation on camptocormia in Parkinson disease
Scientific Title Effect of spinal magnetic stimulation on camptocormia in Parkinson disease
Scientific Title:Acronym Effect of spinal magnetic stimulation on camptocormia in 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 camptocormia, an often treatment-resistant postural abnormality observed in patients with Parkinson disease (PD).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Thoracolumbar spine flexion angle in the standing position
Key secondary outcomes Thoracolumber spine flexion angle in the seated position

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved 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 rTSMS first group. PD patients with camptocormia were administered a single trial of rTSMS (a train of 40 stimuli) followed one week later by sham treatment.
Interventions/Control_2 Patients were allocated sham first group. PD patients with camptocormia were administered a single trial of sham (a train of 40 stimuli) followed one week later by rTSMS treatment.
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 3-4 on the Hoehn and Yahr scale confirmed camptocormia, 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 40

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
Email tmitsui@tokushima-nh.hosp.go.jp

Public contact
Name of contact person
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
Homepage URL
Email tmitsui@tokushima-nh.hosp.go.jp

Sponsor
Institute Department of Clinical Research, Tokushima National Hospital, National Hospital Organization
Institute
Department

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
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 国立病院機構 徳島病院 (徳島県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 16 Day

Related information
URL releasing protocol http://www.tokusimahosp-nho.jp/iin.html
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24780955
Number of participants that the trial has enrolled
Results Of 320 PD patients examined, 37 had concomitant camptocormia and were randomly assigned to either the rTSMS first group (n=19) or sham first group (n=18). Flexion angle in the standing position decreased by a mean of 10.9 degrees (95% CI 8.1 to 13.65) after rTSMS but remained unchanged after sham stimulation (mean, -0.1 degrees; 95% CI -0.95 to 0.71). The flexion angle while sitting (secondary outcome) decreased by 8.1 degrees (95% CI 5.89 to 10.25) after rTSMS, whereas sham treatment had no significant effect (mean, -0.8 degrees; 95% CI -1.62 to 0.05).
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 Main results already published
Date of protocol fixation
2011 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
2013 Year 11 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 15 Day
Last modified on
2017 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013450

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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