UMIN-CTR Clinical Trial

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
Email	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
Email	rinsyou@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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016487