Alzheimer Disease
Conditions
Brief summary
Background: Alzheimer's disease (AD) is characterized by cognitive impairment and behavioral impairment, and increasing attention is paid in the gait of AD patients. The aim of this randomized controlled trial (RCT) is to explore the effect of acupuncture on the cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices. Methods: In this RCT, a total of 108 AD patients will be randomly assigned into acupuncture group or control group for 8 weeks. The primary outcome will be Three-dimensional gait analysis and cerebral hemodynamics using functional near-infrared spectroscopy (fNIRS). Secondary outcomes include Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Barthel Index (BI). Discussion: This trial is expected to explore the effect of acupuncture on cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices for AD patients.
Detailed description
This study aims to assess the clinical effect of acupuncture on gait performance in AD patients and to examine the acupuncture effect on cerebral cortices by identifying hemodynamic changes that occur in the prefrontal cortices using the fNIRS technique.
Interventions
PROCEDUREAcupuncture
Acupoints: Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Taixi (KI3), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), and Shenmen (HT7).
Sponsors
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria are as follows: 1. Aged 40-85 years old; 2. Meeting the mentioned-above diagnostic criteria from traditional Chinese medicine and Western medicine; 3. With mild to moderate dementia (CDR=0.5, 1.0, or 2.0 points); 4. Hachinski Ischemic Scale (HIS) ≤ 4 points; 5. Hamilton Depression Rating Scale (HAMD) \< 20 points; 6. Without severe bone and joint diseases and able to walk independently; 7. Able to conduct vision and hearing tests; 8. Volunteering to participate in this trial and signing an informed consent form.
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Three-dimensional gait analysis | Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments. | Vicon's Nexus system detects gait parameters and kinematic parameters, including step length, stride, pace, step width, step frequency, single/double stand phase, turning (time and number of steps required for turning), swing phase. |
| Cerebral hemodynamics | Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments. | A total of 22 channels are configured using 8 emitters and 8 detectors, with each light source emitting three wavelengths (780 nm, 805 nm, and 830 nm) of light, and the original intensity signal is recorded at a sampling frequency of 13.33Hz. Patients need to try to keep the head fixed during the walking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination | Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments. | MMSE is a 30-point questionnaire, and 1 point is assigned for each correct answer. Testing scores are closely related to education level, and the standard for dividing the normal threshold is \>17 points for patients with illiteracy, \>20 points for patients with primary school, \>22 points for patients with secondary school, and \>23 points for patients with junior college |
| Montreal Cognitive Assessment | Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments. | Total score of this scale is 30 points, and patients with a score of ≥ 26 points are defined as normal. |
| Barthel Index | Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments. | The functional impairment is divided into mild (\> 60 points), moderate (40-60 points), and severe level (≤ 40 points). |
Outcome results
None listed