title: Scalp acupuncture and electromagnetic convergence stimulation for patients with cerebral infarction: study protocol for a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  KCT0001768 . Registered on 14 January 2016.
authors.affiliation: Department of Physical and Rehabilitation Medicine, Chonnam National University Medical School and Hospital, 42, Jebong-ro, Dong-gu, Gwangju City, 61469, Republic of Korea.
authors.forename: Jae-Young
authors.initials: JY
authors.lastname: Han
authors.affiliation: Department of Acupuncture and Moxibustion Medicine, College of Traditional Korean Medicine, Dong-Shin University, 185, Geonjae-ro, Naju City, 58245, Republic of Korea. nahonga@hanmail.net.|Clinical Research Center, Gwangju Traditional Korean Medicine Hospital of Dong-Shin University, 141, Wolsan-ro, Nam-gu, Gwangju City, 61619, Republic of Korea. nahonga@hanmail.net.
authors.forename: Jae-Hong
authors.identifier: 0000-0002-4806-3401
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Clinical Research Center, Gwangju Traditional Korean Medicine Hospital of Dong-Shin University, 141, Wolsan-ro, Nam-gu, Gwangju City, 61619, Republic of Korea.
authors.forename: Ju-Hyung
authors.initials: JH
authors.lastname: Park
authors.affiliation: Department of Korean Medicine Rehabilitation, College of Traditional Korean Medicine, Dong-Shin University, 185, Geonjae-ro, Naju City, 58245, Republic of Korea.
authors.forename: Min-Yeong
authors.initials: MY
authors.lastname: Song
authors.affiliation: Department of Physical and Rehabilitation Medicine, Chonnam National University Medical School and Hospital, 42, Jebong-ro, Dong-gu, Gwangju City, 61469, Republic of Korea.
authors.forename: Min-Keun
authors.initials: MK
authors.lastname: Song
authors.affiliation: Department of Physical and Rehabilitation Medicine, Chonnam National University Medical School and Hospital, 42, Jebong-ro, Dong-gu, Gwangju City, 61469, Republic of Korea.
authors.forename: Dong-Joo
authors.initials: DJ
authors.lastname: Kim
authors.affiliation: Clinical Research Center, Gwangju Traditional Korean Medicine Hospital of Dong-Shin University, 141, Wolsan-ro, Nam-gu, Gwangju City, 61619, Republic of Korea.
authors.forename: Young-Nim
authors.initials: YN
authors.lastname: You
authors.affiliation: Clinical Research Center, Gwangju Traditional Korean Medicine Hospital of Dong-Shin University, 141, Wolsan-ro, Nam-gu, Gwangju City, 61619, Republic of Korea.
authors.forename: Gwang-Cheon
authors.initials: GC
authors.lastname: Park
authors.affiliation: Department of Korean Medicine Rehabilitation, College of Traditional Korean Medicine, Dong-Shin University, 185, Geonjae-ro, Naju City, 58245, Republic of Korea.
authors.forename: Jin-Bong
authors.initials: JB
authors.lastname: Choi
authors.affiliation: Department of Acupuncture and Moxibustion Medicine, College of Traditional Korean Medicine, Dong-Shin University, 185, Geonjae-ro, Naju City, 58245, Republic of Korea.
authors.forename: Myung-Rae
authors.initials: MR
authors.lastname: Cho
authors.affiliation: Department of Acupuncture and Moxibustion Medicine, College of Traditional Korean Medicine, Dong-Shin University, 185, Geonjae-ro, Naju City, 58245, Republic of Korea.
authors.forename: Jeong-Cheol
authors.initials: JC
authors.lastname: Shin
authors.affiliation: Department of Social Welfare, College of Health and Welfare, Dong-Shin University, 185, Geonjae-ro, Naju City, 58245, Republic of Korea.
authors.forename: Ji-Hyun
authors.initials: JH
authors.lastname: Cho
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects; D002544:Cerebral Infarction / Q000628:therapy*; D002985:Clinical Protocols; D006801:Humans; D055670:Medicine, Korean Traditional; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D018401:Sample Size; D012535:Scalp; D016037:Single-Blind Method; D050781:Transcranial Magnetic Stimulation / Q000009:adverse effects
keywords: Cerebral infarction; Collaborative study; Randomized controlled trial; Repetitive transcranial magnetic stimulation; Scalp acupuncture; Study protocol