Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626828
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
The Effect of Electroacupuncture Treatment on Cognitive Function in Adults with Amnestic Mild Cognitive Impairment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Acupuncture and Acupressure Treatment for Amnestic Mild Cognitive Impairment a Pilot Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Amnestic mild cognitive impairment aMCI is a prevalent condition often regarded as the transitional phase between normal cognitive aging and early Alzheimeramp39s disease Conventional treatments for aMCI remain limited with pharmacological interventions showing mixed results and often failing to halt disease progression Electroacupuncture EA is believed to improve cognitive function in various neurodegenerative disorders including aMCI Randomized controlled trials have also reported that acupuncture can positively influence cognitive function by promoting cerebral blood flow and modulating neurotransmitter activity potentially offering a non-pharmacological approach to managing aMCI However robust clinical trials are lacking and there is a need to assess the feasibility and efficacy of EA in treating aMCI This pilot study aims to determine the preliminary efficacy of EA in improving cognitive function and to evaluate the feasibility of the study design for future large-scale trials
Methods
This trial will be a multicenter assessor- and data analyst-blind pilot randomized controlled trial A total of 24 participants aged 55-75 years diagnosed with aMCI will be recruited and randomly assigned in a 11 ratio into either the EA treatment group or a control group Participants in the EA group will receive electroacupuncture at specific acupoints while the control group will not undergo any intervention The intervention will last 4 weeks with two EA sessions per week a total of 8 sessions Assessments will be conducted at three time points baseline post-treatment Week 4 and follow-up Week 6 All participants will continue their standard medical care throughout the trial
The primary outcome will be the change in cognitive function as measured by the Hong Kong version of the Montreal Cognitive Assessment HK-MoCA Secondary outcomes will include changes in the Clinical Dementia Rating CDR and verbal fluency test focusing on the memory domain Safety and adverse events will be monitored throughout the study via follow-up assessments and questionnaires Statistical analyses including linear mixed models LMM will be performed using R and SPSS software adhering to the intention-to-treat principle
Expected Outcomes
This pilot study is expected to provide preliminary data on the efficacy and safety of electroacupuncture in improving cognitive function in patients with aMCI It will also assess the feasibility of conducting a larger-scale trial including participant recruitment adherence to the intervention and the acceptability of outcome measures Findings from this study will offer insights into the therapeutic potential of acupuncture and inform the design of future trials aimed at exploring its role as an alternative or complementary treatment for aMCI
Amnestic mild cognitive impairment aMCI is a prevalent condition often regarded as the transitional phase between normal cognitive aging and early Alzheimeramp39s disease Conventional treatments for aMCI remain limited with pharmacological interventions showing mixed results and often failing to halt disease progression Electroacupuncture EA is believed to improve cognitive function in various neurodegenerative disorders including aMCI Randomized controlled trials have also reported that acupuncture can positively influence cognitive function by promoting cerebral blood flow and modulating neurotransmitter activity potentially offering a non-pharmacological approach to managing aMCI However robust clinical trials are lacking and there is a need to assess the feasibility and efficacy of EA in treating aMCI This pilot study aims to determine the preliminary efficacy of EA in improving cognitive function and to evaluate the feasibility of the study design for future large-scale trials
Methods
This trial will be a multicenter assessor- and data analyst-blind pilot randomized controlled trial A total of 24 participants aged 55-75 years diagnosed with aMCI will be recruited and randomly assigned in a 11 ratio into either the EA treatment group or a control group Participants in the EA group will receive electroacupuncture at specific acupoints while the control group will not undergo any intervention The intervention will last 4 weeks with two EA sessions per week a total of 8 sessions Assessments will be conducted at three time points baseline post-treatment Week 4 and follow-up Week 6 All participants will continue their standard medical care throughout the trial
The primary outcome will be the change in cognitive function as measured by the Hong Kong version of the Montreal Cognitive Assessment HK-MoCA Secondary outcomes will include changes in the Clinical Dementia Rating CDR and verbal fluency test focusing on the memory domain Safety and adverse events will be monitored throughout the study via follow-up assessments and questionnaires Statistical analyses including linear mixed models LMM will be performed using R and SPSS software adhering to the intention-to-treat principle
Expected Outcomes
This pilot study is expected to provide preliminary data on the efficacy and safety of electroacupuncture in improving cognitive function in patients with aMCI It will also assess the feasibility of conducting a larger-scale trial including participant recruitment adherence to the intervention and the acceptability of outcome measures Findings from this study will offer insights into the therapeutic potential of acupuncture and inform the design of future trials aimed at exploring its role as an alternative or complementary treatment for aMCI
Detailed Description:
Ethical Considerations
Ethical approval for this study has been obtained from the Research Ethics Committee of Hong Kong Baptist University REC23-240234 All participants will provide written informed consent before enrollment and their confidentiality and safety will be prioritized throughout the study
Ethical approval for this study has been obtained from the Research Ethics Committee of Hong Kong Baptist University REC23-240234 All participants will provide written informed consent before enrollment and their confidentiality and safety will be prioritized throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None