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Study protocol
Effects of different acupuncture treatment methods on post-stroke cognitive impairment: study protocol for a multicenter randomized controlled trial
Kai-Qi Su
Henan University of Traditional Chinese Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7362-3482
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Cognitive impairment is a common dysfunction after stroke that seriously affects the overall recovery of patients. Cognitive rehabilitation training is currently the main treatment to improve cognitive function, but its curative effect is limited. Acupuncture is a core component of traditional Chinese medicine (TCM), and some previous clinical studies have shown that it might be effective in treating post-stroke cognitive impairment (PSCI), but further evidence from large-sample studies is needed. The overall objective of this trial is to obtain further data to develop an optimized acupuncture treatment for PSCI by comparing the effects of different acupuncture treatment methods on cognitive function in PSCI patients.
Methods/Design: In this multicenter, prospective, randomized controlled trial, 206 eligible stroke inpatients who meet the trial criteria will be randomly assigned to 2 groups: an electroacupuncture (EA) plus needle retention (NR) group and an EA group. Both groups of patients will undergo the same routine cognitive rehabilitation treatments. All treatments will be given 5 times per week for 8 weeks. The primary outcomes will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment scale (MOCA). The secondary outcome will be measured by the Barthel Index (BI). All outcomes will be evaluated at baseline, and week 4, week 8 and at the third and sixth month after the end of treatment.
Discussion: Our aim is to evaluate the effects of two different acupuncture treatment methods for treating PSCI patients. This study is expected to provide data to be used in developing an optimized acupuncture treatment method for PSCI treatment.
Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027849. Registered on 30 November 2019, http://www.chictr.org.cn/showproj.aspx?proj=46316
Keywords
Acupuncture, Cognitive impairment, Stroke, Clinical trial
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Additional file 1: SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents.
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CURRENT STATUS: Published
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Posted 30 Dec, 2020
Published
On 06 Jan, 2021
No community comments so far
Editorial decision: Accept
On 08 Dec, 2020
Reviewers invited
Invitations sent on 03 Dec, 2020
Reviewer #1 agreed
On 03 Dec, 2020
Review #1 received
Received 03 Dec, 2020
Editor assigned
On 29 Nov, 2020
Submission checks complete
On 29 Nov, 2020
No comments provided
Review #3 received
Received 08 Nov, 2020
Editorial decision: Minor revision
On 08 Nov, 2020
Review #4 received
Received 07 Nov, 2020
Review #1 received
Received 03 Nov, 2020
Review #2 received
Received 03 Nov, 2020
Reviewer #4 agreed
On 30 Oct, 2020
Reviewer #3 agreed
On 25 Oct, 2020
Reviewer #2 agreed
On 24 Oct, 2020
Reviewers invited
Invitations sent on 23 Oct, 2020
Reviewer #1 agreed
On 23 Oct, 2020
Editor assigned
On 10 Sep, 2020
Submission checks complete
On 05 Aug, 2020
First submitted
On 29 May, 2020
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Effects of different acupuncture treatment methods on post-stroke cognitive impairment: study protocol for a multicenter randomized controlled trial
Kai-Qi Su
Henan University of Traditional Chinese Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7362-3482
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 30 Dec, 2020
Published
On 06 Jan, 2021
No community comments so far
Editorial decision: Accept
On 08 Dec, 2020
Reviewers invited
Invitations sent on 03 Dec, 2020
Reviewer #1 agreed
On 03 Dec, 2020
Review #1 received
Received 03 Dec, 2020
Editor assigned
On 29 Nov, 2020
Submission checks complete
On 29 Nov, 2020
No comments provided
Review #3 received
Received 08 Nov, 2020
Editorial decision: Minor revision
On 08 Nov, 2020
Review #4 received
Received 07 Nov, 2020
Review #1 received
Received 03 Nov, 2020
Review #2 received
Received 03 Nov, 2020
Reviewer #4 agreed
On 30 Oct, 2020
Reviewer #3 agreed
On 25 Oct, 2020
Reviewer #2 agreed
On 24 Oct, 2020
Reviewers invited
Invitations sent on 23 Oct, 2020
Reviewer #1 agreed
On 23 Oct, 2020
Editor assigned
On 10 Sep, 2020
Submission checks complete
On 05 Aug, 2020
First submitted
On 29 May, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Cognitive impairment is a common dysfunction after stroke that seriously affects the overall recovery of patients. Cognitive rehabilitation training is currently the main treatment to improve cognitive function, but its curative effect is limited. Acupuncture is a core component of traditional Chinese medicine (TCM), and some previous clinical studies have shown that it might be effective in treating post-stroke cognitive impairment (PSCI), but further evidence from large-sample studies is needed. The overall objective of this trial is to obtain further data to develop an optimized acupuncture treatment for PSCI by comparing the effects of different acupuncture treatment methods on cognitive function in PSCI patients.
Methods/Design: In this multicenter, prospective, randomized controlled trial, 206 eligible stroke inpatients who meet the trial criteria will be randomly assigned to 2 groups: an electroacupuncture (EA) plus needle retention (NR) group and an EA group. Both groups of patients will undergo the same routine cognitive rehabilitation treatments. All treatments will be given 5 times per week for 8 weeks. The primary outcomes will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment scale (MOCA). The secondary outcome will be measured by the Barthel Index (BI). All outcomes will be evaluated at baseline, and week 4, week 8 and at the third and sixth month after the end of treatment.
Discussion: Our aim is to evaluate the effects of two different acupuncture treatment methods for treating PSCI patients. This study is expected to provide data to be used in developing an optimized acupuncture treatment method for PSCI treatment.
Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027849. Registered on 30 November 2019, http://www.chictr.org.cn/showproj.aspx?proj=46316
Figure 1