Clinical trial NCT06346275: Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex
Official title: Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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.

Primary outcomes:
measure: Three-dimensional gait analysis
timeFrame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
measure: Cerebral hemodynamics
timeFrame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
Secondary outcomes:
measure: Mini-Mental State Examination
timeFrame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
measure: Montreal Cognitive Assessment
timeFrame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
measure: Barthel Index
timeFrame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
Other outcomes:
Locations:
Study officials:
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