Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex

Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex: Study Protocol for a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Procedure: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 exclusion criteria are as follows:

1. Dementia caused by other systemic or neurological diseases, such as central nervous system infections, post-traumatic dementia, Parkinson's disease dementia;
2. Suffering from acute illness, upper limb extrapyramidal stiffness, neurological or psychiatric disorders (except cognitive impairment);
3. With medical history that interferes with cognitive function assessment, such as past history of psychiatric drug abuse, drug addiction within the past 5 years, and alcohol abuse;
4. Afraid of acupuncture and cannot accept acupuncture treatment;
5. Currently participating in other clinical trial that affects the outcome evaluation of this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Cognitive rehabilitation therapy: The cognitive training system (JZ-RZ-1020, Extreme Medical Technology, Hangzhou, China) will be used to help develop personalized rehabilitation plans for one-on-one training based on the cognitive function of each patient. The trainings include memory, hand eye reinforcement, attention, reaction. Patients are treated for 30 minutes each time and 5 times a week for 8 weeks.	Procedure: Acupuncture; Acupoints: Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Taixi (KI3), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), and Shenmen (HT7).
Experimental: Acupuncture group; Acupoints: Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Taixi (KI3), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), and Shenmen (HT7).	Procedure: Acupuncture; Acupoints: Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Taixi (KI3), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), and Shenmen (HT7).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three-dimensional gait analysis	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.	Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
Cerebral hemodynamics	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.	Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination	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	Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
Montreal Cognitive Assessment	Total score of this scale is 30 points, and patients with a score of ≥ 26 points are defined as normal.	Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
Barthel Index	The functional impairment is divided into mild (> 60 points), moderate (40-60 points), and severe level (≤ 40 points).	Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.

Collaborators and Investigators

• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 3rdZhejiangCMU-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No