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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346275
• Other study ID #: 3rdZhejiangCMU-11
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Procedure:
• Acupuncture
Acupoints: Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Taixi (KI3), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), and Shenmen (HT7).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.