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

NCT06346275 | Not Yet Recruiting

• 1 other identifier: 3rdZhejiangCMU-11
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Mini-Mental State Examination

  Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.

• Montreal Cognitive Assessment

  Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.

• Barthel Index

  Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Acupuncture group

EXPERIMENTAL

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

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

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

Acupuncture group; Control group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40-85 years old;
• Meeting the mentioned-above diagnostic criteria from traditional Chinese medicine and Western medicine;
• With mild to moderate dementia (CDR=0.5, 1.0, or 2.0 points);
• Hachinski Ischemic Scale (HIS) ≤ 4 points;
• Hamilton Depression Rating Scale (HAMD) \< 20 points;
• Without severe bone and joint diseases and able to walk independently;
• Able to conduct vision and hearing tests;

You may not qualify if:

• Dementia caused by other systemic or neurological diseases, such as central nervous system infections, post-traumatic dementia, Parkinson's disease dementia;
• Suffering from acute illness, upper limb extrapyramidal stiffness, neurological or psychiatric disorders (except cognitive impairment);
• 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;
• Afraid of acupuncture and cannot accept acupuncture treatment;
• Currently participating in other clinical trial that affects the outcome evaluation of this trial.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 4, 2024
• Study Start: July 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share