jRCT ロゴ

臨床研究等提出・公開システム

Top

Japanese

June. 12, 2015

Nov. 12, 2021

jRCT1091220215

The Comparison of Treatment Sequence of Parallel rTMS and Rehabilitation and Rehabilitation Only
(Effects of rTMS therapy in assessing stroke hemiparesis)

The Comparison of Treatment Sequence of Parallel rTMS and Rehabilitation and Rehabilitation Only

Mar. 31, 2020

47

https://www.ncbi.nlm.nih.gov/pubmed/26335615

Naoki Yamada

The Jikei University School of Medicine

4-11-1, Izumihontyo-komaeshi,
Tokyo, Japan

+81-70-3914-2190

n-yamada@jikei.ac.jp

Naoki Yamada

The Jikei University School of Medicine

4-11-1 komae city Tokyo

+81-3-3480-1151

n-yamada@jikei.ac.jp

COMPLETED

April. 03, 2015

50

Interventional

Experimental Study

open(masking not used)

Yes

N/A

1) motor-dominant aphasia caused by left hemispheric stroke in a right-handed subject; 2) age at intervention between 20-80 years; 3) time between the onset of stroke and treatment of more than 12 months; 4) history of a single stroke only (no bilateral cerebrovascular lesion); 5) no cognitive impairment with a pretreatment Mini Mental State Examination score of more than 26; 6) clinical confirmation of a plateau state (no increases in the WAB and Token Test scores as measured by a speech therapist from the institution in the last 3 months); 7) no active physical or mental illness requiring medical management; 8) no contraindications to atomoxetine administration (serious cardiovascular disturbance, pheochromocytoma, closed angle glaucoma and impaired liver function); and 9) sufficient understanding of the study contents.

contraindications to atomoxetine administration (serious cardiovascular disturbance, pheochromocytoma, closed angle glaucoma and impaired liver function)

20age old over
85age old under

Both

post-stroke hemiparesis

Intervention type:DRUG Name of intervention:Effects of rTMS therapy in assessing stroke hemiparesis Dose form / Japanese Medical Device Nomenclature:DEVICE Route of administration / Site of application:ORAL Dose per administration:2400 2400 stim Dosing frequency / Frequency of use:QD once per day Planned duration of intervention:four weeks Intended dose regimen:Group A consisted of 16 patients who underwent NEURO first, and Group B consisted of 21 patients who underwent OT first for 2 weeks. After 2 weeks of hospitalization, the treatment for Group A and Group B were reversed and continued for an additional two weeks of treatment. detailes of teratment arms:Group A consisted of 16 patients who underwent NEUROR first, and Group B consisted of 21 patients who underwent OT first for 2 weeks. After 2 weeks of hospitalization, the treatment for Group A and Group B were reversed and continued for an additional two weeks of treatment. Comparative intervention name:none Dose form / Japanese Medical Device Nomenclature:DEVICE Route of administration / Site of application:NOT APPLICABLE Dose per administration:2400 2400 stimulation stimulation Dosing frequency / Frequency of use:QD once per day Planned duration of intervention:4week Intended dose regimen:low-frequency rTMS applied to a healthy cerebrum

safety, feasibility, and efficacy

Japanese version of WAB and the Token Test

The Jikei University School of Medicine
The Jikei University School of Medicine
the study funding of the rehabilitation department of Jikei University School of Medicine
the ethics committee of The Jikei University School of Medicine

Yes

June. 30, 2014

-->
JMA-IIA00215
Japan

History of Changes

No Publication date
2 Nov. 12, 2021 (this page) Changes
1 June. 12, 2015 Detail