Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study
BackgroundMild cognitive impairment (MCI) is an intermediary condition between typical cognitive decline that occurs owing to aging and dementia. It is necessary to implement an intervention to slow the progression from MCI to Alzheimer’s disease. This manuscript reports the protocol for a clinical...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-03-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2024.1346858/full |
| _version_ | 1827317428501086208 |
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| author | Jae-Hong Kim Jae-Hong Kim Jeong-Cheol Shin Ae-Ran Kim Bok-Nam Seo Gwang-Cheon Park Byoung-Kab Kang Jeong-Soon Lee |
| author_facet | Jae-Hong Kim Jae-Hong Kim Jeong-Cheol Shin Ae-Ran Kim Bok-Nam Seo Gwang-Cheon Park Byoung-Kab Kang Jeong-Soon Lee |
| author_sort | Jae-Hong Kim |
| collection | DOAJ |
| description | BackgroundMild cognitive impairment (MCI) is an intermediary condition between typical cognitive decline that occurs owing to aging and dementia. It is necessary to implement an intervention to slow the progression from MCI to Alzheimer’s disease. This manuscript reports the protocol for a clinical trial on the effect of acupuncture in patients with MCI.MethodsThe trial will be a randomized, prospective, parallel-arm, active-controlled trial. Sixty-four patients with MCI will be randomized to the Rehacom or acupuncture group (n = 32 each). The participants in the acupuncture group will receive electroacupuncture at GV24 (Shenting) and GV20 (Baihui) and acupuncture at EX-HN1 (Sishencong) once (30 min) a day, twice per week for 12 weeks. The patients in the Rehacom group will receive computerized cognitive rehabilitation using RehaCom software once (30 min) daily, twice weekly for 12 weeks. The primary outcome measure is the change in the Montreal Cognitive Assessment Scale score. The secondary outcome measures are the Geriatric Depression Scale, Alzheimer’s Disease Assessment Scale-Korean version-cognitive subscale-3 scores, and European Quality of Life Five Dimensions Five Level Scale. The safety outcomes will include the incidence of adverse events, blood pressure, blood chemistry parameters, and pulse rate. The efficacy outcome will be assessed at baseline and at six weeks, 13 weeks, and 24 weeks after baseline.DiscussionThe findings of this protocol will provide information regarding the effects of acupuncture on MCI.Clinical trial registrationhttps://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=M&pageSize=10&page=undefined&seq=25579&status=5&seq_group=25579, KCT0008861. |
| first_indexed | 2024-04-24T23:37:40Z |
| format | Article |
| id | doaj.art-17f5ee17d898410fa974478d82e7c9f1 |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-04-24T23:37:40Z |
| publishDate | 2024-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-17f5ee17d898410fa974478d82e7c9f12024-03-15T14:11:31ZengFrontiers Media S.A.Frontiers in Neurology1664-22952024-03-011510.3389/fneur.2024.13468581346858Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical studyJae-Hong Kim0Jae-Hong Kim1Jeong-Cheol Shin2Ae-Ran Kim3Bok-Nam Seo4Gwang-Cheon Park5Byoung-Kab Kang6Jeong-Soon Lee7Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dongshin University, Naju, Republic of KoreaClinical Research Center, Dongshin University Gwangju Korean Medicine Hospital, Gwangju, Republic of KoreaDepartment of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dongshin University, Naju, Republic of KoreaClinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaClinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaClinical Research Center, Dongshin University Gwangju Korean Medicine Hospital, Gwangju, Republic of KoreaKM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaDepartment of Nursing, Christian College of Nursing, Gwangju, Republic of KoreaBackgroundMild cognitive impairment (MCI) is an intermediary condition between typical cognitive decline that occurs owing to aging and dementia. It is necessary to implement an intervention to slow the progression from MCI to Alzheimer’s disease. This manuscript reports the protocol for a clinical trial on the effect of acupuncture in patients with MCI.MethodsThe trial will be a randomized, prospective, parallel-arm, active-controlled trial. Sixty-four patients with MCI will be randomized to the Rehacom or acupuncture group (n = 32 each). The participants in the acupuncture group will receive electroacupuncture at GV24 (Shenting) and GV20 (Baihui) and acupuncture at EX-HN1 (Sishencong) once (30 min) a day, twice per week for 12 weeks. The patients in the Rehacom group will receive computerized cognitive rehabilitation using RehaCom software once (30 min) daily, twice weekly for 12 weeks. The primary outcome measure is the change in the Montreal Cognitive Assessment Scale score. The secondary outcome measures are the Geriatric Depression Scale, Alzheimer’s Disease Assessment Scale-Korean version-cognitive subscale-3 scores, and European Quality of Life Five Dimensions Five Level Scale. The safety outcomes will include the incidence of adverse events, blood pressure, blood chemistry parameters, and pulse rate. The efficacy outcome will be assessed at baseline and at six weeks, 13 weeks, and 24 weeks after baseline.DiscussionThe findings of this protocol will provide information regarding the effects of acupuncture on MCI.Clinical trial registrationhttps://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=M&pageSize=10&page=undefined&seq=25579&status=5&seq_group=25579, KCT0008861.https://www.frontiersin.org/articles/10.3389/fneur.2024.1346858/fullacupuncturecomputerized cognitive rehabilitationRehaCommild cognitive impairmentstudy protocol |
| spellingShingle | Jae-Hong Kim Jae-Hong Kim Jeong-Cheol Shin Ae-Ran Kim Bok-Nam Seo Gwang-Cheon Park Byoung-Kab Kang Jeong-Soon Lee Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study Frontiers in Neurology acupuncture computerized cognitive rehabilitation RehaCom mild cognitive impairment study protocol |
| title | Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study |
| title_full | Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study |
| title_fullStr | Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study |
| title_full_unstemmed | Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study |
| title_short | Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study |
| title_sort | safety and efficacy of acupuncture for mild cognitive impairment a study protocol for clinical study |
| topic | acupuncture computerized cognitive rehabilitation RehaCom mild cognitive impairment study protocol |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2024.1346858/full |
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