臨床研究等提出・公開システム

Date of registration	Jan. 07, 2026
Last modified on	Jan. 07, 2026
Trial ID	jRCTs032250617

Scientific Title	Efficacy of the Functional Improvement Effects of Different Stimulation Methods of Repetitive Transcranial Magnetic Stimulation for Upper Limb Paralysis After Stroke: Randomized Controlled Trial
Public Title	Efficacy of rTMS for upper limb paralysis after stroke

Contact for Scientific Queries	Name	Kikuchi Naohisa
	Affiliation	Chiba Rehabilitation Center
	Address	1-45-2 Hondacho, Midori-ku, Chiba city
	Telephone	+81-43-291-1831
	E-mail	kikuchi@chiba-reha.jp
Contact for Public Queries	Name	Murayama Takashi
	Affiliation	Chiba Rehabilitation Center
	Address	1-45-2 Hondacho, Midori-ku, Chiba city
	Telephone	+81-43-291-1831
	E-mail	takashi.murayama@chiba-reha.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 07, 2026
Target sample size		88
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Study1 (1) Age: 20-80 (2) Under the agreement with written consent form (3) Diagnosed as stroke by a physician (4) Inpatient at Chiba Rehabilitation Center (5) 2 months after onset (6) MEPs appears (7) Fugl-Meyer Assessment for upper extremity item of 20 or more (8) The weekly upper extremity motor score is limited to a change within the standard error for two consecutive weeks Study2 (1) Age: 20-80 (2) Under the agreement with written consent form (3) Diagnosed as stroke by a physician (4) Inpatient at Chiba Rehabilitation Center (5) 2 months after onset (6) MEPs does not appear. (7) Fugl-Meyer Assessment for upper extremity item are 19 points or less (8) The weekly upper extremity motor score is limited to a change within the standard error for two consecutive weeks
	Exclusion Criteria	(1) Fit into following cases History of harmful sides effects due to magnetic or electrical stimulation. History of seizure or epilepsy. Disease or injury of head, brain, peripheral nerves including brain surgery prior to the onset of the current illness or injury. Medical device implantation such as cardiac pacemaker, neurosurgical clips, battery or pumps, non-titanium metal implants in the head or the stimulus target area of trunk. Chronic severe migraine, Suspicion of pregnancy (2) Buried metal cannot be identified as titanium. (3) Inappropriate patient decided by a physician (4) Current participation in clinical trials for an approved drug or clinical device (5) History of botulinum toxin therapy within 3 months (6) Over 57 points the FMA for upper extremity item
	Age Minimum	20age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Stroke
Intervention(s)		repetitive Transcranial Magnetic Stimulation
Primary Outcome(s)		Fugl-Meyer Assessment for upper extremity item
Secondary Outcome(s)		Subtest scores Fugl-Meyer Assessment for upper extremity item, ARAT (Action Research Arm Test), BBT(Box & Block Test), Motor evoked potential elicited by transcranial magnetic stimulation, ipsilateral silent period by transcranial magnetic stimulation *Study2 only, Magnetic resonance imaging, Safety Assessments

Name of Certified Review Board	Yokohama City University Certified Instit
Address	3-9, Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa, Japan, Kanagawa
Telephone	+81-45-370-7627
E-Mail	ycu_crb@yokohama-cu.ac.jp
Approval Status	Approval
Date of approval	Sept. 04, 2025

Plan to share IPD	Yes
Plan description	Data registration and storage will be done using UHCT ACReSS (UHCT Alliance Clinical Research Supporting System).

Countries of Recruitment（Except Japan）	none