The Study of Mechanism of Alzheimer's Disease Using Acupuncture Based on fMRI

October 4, 2016 updated by: likuncheng, Xuanwu Hospital, Beijing

The Study of Brain Functional Network Modulatory Mechanism of Alzheimer's Disease Using Acupuncture at the "Four-gate" Acupoints

Alzheimer's disease (AD) is one of the major brain diseases which received more attention in recent years. The disconnection syndrome is the main pathophysiological mechanism leading to cognitive decline in AD patients. Both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on AD patients by moderating the neural pathway directly. However, the underlying mechanism remains unclear. By using resting state functional magnetic resonance imaging (fMRI) method, as well as acupuncture and neurology sciences, investigators will explore the multi-modality data analysis; compare brain connectivity and network parameters changes between pre- and post- acupuncture treatment; analyze the correlation between fMRI changes and neuropsychology test. The present study aims to elucidate the neural mechanism of acupuncture therapy on early AD, provide theoretical evidence from the perspective of functional connectivity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
      • Beijing, Beijing, China
        • Not yet recruiting
        • Dongfang Hospital,Beijing University of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical diagnosis of Alzheimer's Disease Clinical diagnosis of MCI due to Alzheimer's Disease Drug therapy regularly

Exclusion Criteria:

Frontotemporal dementia Lewy body dementia Vascular dementia Severe depression Brain vascular disease Metabolic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AD-true acupuncture
True acupuncture at the "four-gate"acupoints will be administered on AD patients
Procedure: true acupuncture
acupuncture at the "four-gate"acupoints, three times per week and last for 6 months
SHAM_COMPARATOR: AD-sham acupuncture
Sham acupuncture at the "four-gate"acupoints will be administered on AD patients
Procedure: sham acupuncture
acupuncture at the places 1cm from the true "four-gate "acupoints,three times per week and last for 6 months
EXPERIMENTAL: Mild Cognitive Impairment(MCI)-true acupuncture
True acupuncture at the "four-gate"acupoints will be administered on MCI patients
Procedure: true acupuncture
acupuncture at the "four-gate"acupoints, three times per week and last for 6 months
SHAM_COMPARATOR: MCI-sham acupuncture
Sham acupuncture at the "four-gate"acupoints will be administered on MCI patients
Procedure: sham acupuncture
acupuncture at the places 1cm from the true "four-gate "acupoints,three times per week and last for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
brain functional connectivity
Time Frame: with in first week after the whole acupuncture treatment
GE750 3.0T gradient-echo single-shot echo plannar imaging TR=2000ms TE=30ms slice=36 slice thickness=3mm gap=1mm volumes=180
with in first week after the whole acupuncture treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (ESTIMATE)

May 3, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81471649

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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