Alzheimer DiseaseNCT06346275
Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex
A study testing Acupuncture in people with Alzheimer Disease, run by The Third Affiliated hospital of Zhejiang Chinese Medical University.
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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
The inclusion criteria are as follows:
- 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;
- Volunteering to participate in this trial and signing an informed consent form. Exclusion criteria
The exclusion criteria are as follows:
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Acupuncture
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupoints: Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Taixi (KI3), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), and Shenmen (HT7).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Acupuncture |
| Acupuncture group | Experimental | Acupoints: Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Taixi (KI3), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), and Shenmen (HT7). Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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
Measured: 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.
Measured: 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).
Measured: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jul 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenmei Hong, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346275
- Sponsor's protocol ID
- 3rdZhejiangCMU-11
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06346275
- Acronym / sponsor ID
- 3rdZhejiangCMU-11
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: AcupunctureCognitive 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. |
| Acupuncture group | Experimental | Procedure: AcupunctureAcupoints: Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Taixi (KI3), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), and Shenmen (HT7). |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupoints: Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Taixi (KI3), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), and Shenmen (HT7). | Procedure or surgery | Acupuncture group, Control group |
Primary outcome
Three-dimensional gait analysis
Time frame: 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
Time frame: 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.
3 secondary outcomes
Mini-Mental State Examination
Time frame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
Montreal Cognitive Assessment
Time frame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
Barthel Index
Time frame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Alzheimer Disease, run by The Third Affiliated hospital of Zhejiang Chinese Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-dimensional gait analysis (time frame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.