UMIN-CTR Clinical Trial

Basic information
Public title	A study on the clinical effect of intensive intensive therapy and recurrent transcranial magnetic stimulation for upper limb dysfunction in patients with chronic stroke hemiplegia
Acronym	A study on the clinical effect of intensive intensive therapy and recurrent transcranial magnetic stimulation for upper limb dysfunction in patients with chronic stroke hemiplegia
Scientific Title	A study on the clinical effect of intensive intensive therapy and recurrent transcranial magnetic stimulation for upper limb dysfunction in patients with chronic stroke hemiplegia
Scientific Title:Acronym	A study on the clinical effect of intensive intensive therapy and recurrent transcranial magnetic stimulation for upper limb dysfunction in patients with chronic stroke hemiplegia
Region	Japan

Condition
Condition	Stroke hemiplegia
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Although the safety and usefulness of repetitive transcranial magnetic stimulation (rTMS) for stroke hemiplegia have been established, the clinical effects of combination therapy have not been sufficiently investigated. In this study, 40 patients with chronic hemiplegia including the elderly were treated with 90% stimulation of rTMS threshold and 10% with the purpose of clarifying the synergistic effect, the duration of the effect, and the usefulness in the elderly. Randomly assign to stimulation groups, perform intensive intensification therapy and prescribed rTMS to verify clinical effect.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fugl-Meyer assessment Wolf Motor Function Test Motor Activity Log FIM,BI
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The subject is admitted to the hospital, and 90% of the rTMS motor threshold is stimulated in the healthy motor area using the Magstim Super Rapid with 1,200 1Hz rTMS at a given stimulus intensity. Immediately perform intensive reinforcement training (20 minutes for robot-assisted training for upper limbs using MA2, 40 minutes for goal-oriented repetitive training by an occupational therapist, and 60 minutes for self-training instructed by OT). During the other hours, 60 minutes of voluntary physical therapy (walking training to suspend the trunk by using a suspended walker to prevent falls and continuous extension of the ankles) is performed. These interventions will be conducted for 10 days on weekdays, and will be instructed to perform only voluntary training on weekends and festivals.
Interventions/Control_2	The subject is admitted to the hospital, and 10% rTMS motor threshold stimulation is applied to the motor area on the unaffected side using Magstim Super Rapid with 1,200 1Hz rTMS at a predetermined stimulation intensity. Immediately perform intensive reinforcement training (20 minutes for robot-assisted training for upper limbs using MA2, 40 minutes for goal-oriented repetitive training by an occupational therapist, and 60 minutes for self-training instructed by OT). During the other hours, 60 minutes of voluntary physical therapy (walking training to suspend the trunk by using a suspended walker to prevent falls and continuous extension of the ankles) is performed. These interventions will be conducted for 10 days on weekdays, and will be instructed to perform only voluntary training on weekends and festivals.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic stroke hemiplegia who have mild to moderate paralysis in the upper limbs, who wish to improve upper limb paralysis, have no history of epileptic seizures, and have no epileptic discharge on EEG.
Key exclusion criteria	Patients with contraindication of rTMS
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yousuke Middle name Last name Nagano
Organization	Kyushu Rosai Hospital Moji Medical Center
Division name	Central rehabilitation department
Zip code	801-0853
Address	3-1 Higashiminato-cho, Moji-ku, Kitakyushu City, Fukuoka Prefecture
TEL	09074442673
Email	terasama74@gmail.com

Public contact
Name of contact person	1st name Naoki Middle name Last name Matsumura
Organization	Kyushu Rosai Hospital Moji Medical Center
Division name	Central rehabilitation department
Zip code	801-0853
Address	3-1 Higashiminato-cho, Moji-ku, Kitakyushu City, Fukuoka Prefecture
TEL	093-331-3461
Homepage URL
Email	terasama74@gmail.com

Sponsor
Institute	Incorporated Administrative Agency Workers Health and Safety Organization Kyushu Rosai Hospital Moji Medical Center
Institute
Department

Funding Source
Organization	Incorporated Administrative Agency Workers Health and Safety Organization Kyushu Rosai Hospital Moji Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Incorporated Administrative Agency Workers Health and Safety Organization Kyushu Rosai Hospital Moji Medical Center
Address	3-1 Higashiminato-cho, Moji-ku, Kitakyushu City, Fukuoka Prefecture
Tel	093-331-3461
Email	terasama74@gmail.com

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	2020 Year 07 Month 21 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	2020 Year 02 Month 20 Day
Date of IRB	2020 Year 03 Month 04 Day
Anticipated trial start date	2020 Year 03 Month 04 Day
Last follow-up date	2023 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 21 Day
Last modified on	2020 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047025