Background:Mild cognitive impairment(MCI) is the clinical stage of cognition impairment between normal aging and Alzheimer’s disease(AD). It is important to find early and available interventions to delay the development from MCI to AD. Feasible complementary and alternative therapies, such as electroacupuncture(EA), exercise, and cognitive training have shown some benefits to treat MCI and AD. The aim of this study is to investigate the efficacy of EA on MCI by comparing  EA and computerized cognitive rehabilitation(CCR).

Methods/Design: This study is a prospective, outcome assessor-blinded, parallel-arm, randomized, controlled single center(DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), clinical trial with a 1:1allocation ratio. Participants(n=64) with MCI will be randomly assigned to either a CCR group(n=32)or an EAgroup(n=32).The CCR group will receive Rehacom cognitive rehabilitation once(30 minutes) per day, twice a week  for 12 weeks.  The EA group will receive  electroacupuncture treatment at Baihui(GV20) and  Shenting(GV24)(EX-HN1), and acupuncture at Fengchi(GB20) and  Sishencong(EX-HN1) once per day twice a week for 12 weeks. The primary outcome will be improvement of cognitive function assessed according to Korean version of the Montreal Cognitive Assessment(MoCA-K), while , Korean version of Alzheimer’s Disease Assessment Scale – cognitive subscale 3(ADAS-K-cog 3), Geriatric Depression scale(GDS), and European Quality of Life Five Dimension-Five Level Scale(EQ-5D-5L) score will be considered as secondary outcome measures. MoCA-K, ADAS-K-cog 3, GDS, and EQ-5D-5L measurements will be performed at baseline(before intervention), after 12th treatments, 1 week after the the end of intervention, and 12 weeks after the completion of intervention.

Treatment

- Computerized cognitive rehabilitation(CCR) group: Computerized cognitive rehabilitation (Rehacom) software treatment tasks are performed  for 30 minutes once daily, twice a week for 12 weeks
- Electroacupuncture(EA) group: - Electroacupuncture at Baihui(GV20) and Shenting(GV24), and  acupuncture at Sishencong(EX-HN1) for 30 minutes once daily, twice a week for 12 weeks

Arm Label

Target Number of Participant

Arm Type

Arm Description

CCR group: Computerized cognitive rehabilitation (Rehacom) software treatment tasks are performed  for 30 minutes  once daily twice a week for 12 weeks

Arm Label

Target Number of Participant

Arm Type

Arm Description

Electroacupuncture(EA) group: - Electroacupuncture at Baihui(GV20) and Shenting(GV24), and  acupuncture at Sishencong(EX-HN1) for 30 minutes once daily twice a week for 12 weeks

Gender

Age

Description

1. an elderly aged between 55 and 85 years
2. impaired memory lasting for at least 3 months meeting the diagnostic criteria for MCI 
3. Global Deterioration scale score of 2 or 3
4. Korean version of Mini-Mental State Examination(K-MMSE) score of 20–23
5. Korean version of Montreal Cognitive Assessment scale (MoCA-K) score of 0-22
6. Geriatric Depression Scale (GDS) score of 0-18
7. at least six years of education or adequate Korean language proficiency for reliable study assessments
8. voluntary provision of informed consent.

1. Diagnosis of vascular dementia according to the NINDS-AIREN criteria or diagnosis of AD according to the NINCDS-ADRDA criteria
2. a history of structural brain lesions that could cause cognitive decline, such as congenital mental retardation, stroke, traumatic brain injury, or intracranial space-occupying lesions
3. presence of a serious illness (e.g., Huntington disease, Parkinson's disease, cancer, central nervous system, liver, cardiovascular, and kidney diseases, and multiple sclerosis) 
4. a history of brain diseases confirmed on brain magnetic resonance imaging or computed tomography within 12 months
5. history of treatment for drug or alcohol dependency or mental illness (schizophrenia, serious anxiety, or depression) within 6 months prior to screening
6.current treatment for MCI, such as Korean medicine treatment, medication, or cognitive training within 4 weeks before screening
7. difficulties in undergoing outcome measurement due to visual and hearing impairments
8. unfitness for electroacupuncture (e.g., blood-clotting abnormalities such as hemophilia, scalp infection, and presence of a pacemaker)
9. pregnancy or breastfeeding
10. A people who is participating in other trials or has participated in other trials within 8 weeks prior to screening

Korean version of the Montreal Cognitive Assessment(MoCA-K)

baseline, after 12th treatment(week7), a week after end of intervention(week13), 12 weeks after end of intervetion(week24)

Alzheimer's Disease Asessment Scale-Korean version-cognitive subscale-3(ADAS-K-cog-3)

baseline, after 12 treatment(week7), a week after end of intervention(week13), 12 weeks after end of intervetion(week24)

Geriatric Depression scale(GDS)

baseline, after 12 treatment(week7), a week after end of intervention(week13), 12 weeks after end of intervetion(week24)

European Quality of Life Five Dimension. Five Level Scale(EQ-5D-5L)

baseline, after 12 treatment(week7), a week after end of intervention(week13), 12 weeks after end of intervetion(week24)