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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Scalp acupuncture and electromagnetic convergence stimulation for patients with cerebral infarction: study protocol for a randomized controlled trial

Authors: Jae-Young Han, Jae-Hong Kim, Ju-Hyung Park, Min-Yeong Song, Min-Keun Song, Dong-Joo Kim, Young-Nim You, Gwang-Cheon Park, Jin-Bong Choi, Myung-Rae Cho, Jeong-Cheol Shin, Ji-Hyun Cho

Published in: Trials | Issue 1/2016

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Abstract

Background

Scalp acupuncture (SA) and repetitive transcranial magnetic stimulation (rTMS) are effective for treating cerebral infarction. This study aims to examine the efficacy and safety of SA and electromagnetic convergence stimulation (SAEM-CS), which was developed through collaboration between conventional medical physicians and doctors who practice traditional Korean medicine. SAEM-CS was designed to improve function in patients with cerebral infarction, compared to the improvement after conventional stroke rehabilitation, SA, and rTMS therapeutic approaches.

Methods/design

This study is a prospective, outcome assessor-blinded, randomized controlled clinical trial with a 1:1:1:1 allocation ratio. Participants with motion or sensory disabilities caused by a first-time cerebral infarction (n = 60) that had occurred within 1 month of the study onset will be randomly assigned to control, SA, rTMS, or SAEM-CS groups. All groups will receive two sessions of conventional rehabilitation treatment per day. The SA group will receive SA on the upper limb area of MS6 and MS7 (at the lesional hemisphere) for 20 min, the rTMS group will receive low-frequency rTMS (LF-rTMS) treatment on the hot spot of the M1 region (motor cortex at the contralesional hemisphere) for 20 min, and the SAEM-CS group will receive LF-rTMS over the contralesional M1 region hot spot while receiving simultaneous SA stimulation on the lesional upper limb area of MS6 and MS7 for 20 min. SA, rTMS, and SAEM-CS treatments will be conducted once/day, 5 days/week (excluding Saturdays and Sundays) for 3 weeks, for a total of 15 sessions. The primary outcome will be evaluated using the Fugl‐Meyer Assessment, while other scales assessing cognitive function, activities of daily living, walking, quality of life, and stroke severity are considered secondary outcome measures. Outcome measurements will be conducted at baseline (before intervention), 3 weeks after the first intervention (end of intervention), and 4 weeks after intervention completion.

Discussion

This study aims to explore the efficacy and safety of SAEM-CS on cerebral infarction. Collaborative research combined traditional Korean and conventional medicines, which can be useful in developing new treatment technologies.

Trial registration

KCT0001768. Registered on 14 January 2016.
Appendix
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Metadata
Title
Scalp acupuncture and electromagnetic convergence stimulation for patients with cerebral infarction: study protocol for a randomized controlled trial
Authors
Jae-Young Han
Jae-Hong Kim
Ju-Hyung Park
Min-Yeong Song
Min-Keun Song
Dong-Joo Kim
Young-Nim You
Gwang-Cheon Park
Jin-Bong Choi
Myung-Rae Cho
Jeong-Cheol Shin
Ji-Hyun Cho
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1611-y

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