Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study
NCT ID: NCT03386903
Last Updated: 2017-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2018-02-28
2019-06-28
Brief Summary
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Detailed Description
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The investigators are assigned the ninety eligible participants in three groups: thirty chronic insomnia patients by true acupuncture treatment (Zhoushi coordinated points), thirty chronic insomnia patients by sham acupuncture stimulation (non-acupoint points) and thirty healthy subjects, Treatment will be given 3 times per week for 3 months. Additionally, two methods include functional magnetic resonance imaging (fMRI) and clinical scales evaluation as the outcome measures to evaluate the effectiveness and security of acupuncture. Outcomes will be evaluated at baseline and 3 month post-treatment.
The aim of this project is to investigate effect of acupuncture treatment on gray matter and functional connectivity of the default network and the salience network in chronic insomnia patients, and to analyze the association between sleep quality, emotion, day function with imaging results. The central nervous mechanisms underlying acupuncture treatment are discussed by this finding which may provide scientific basis for acupuncture treatment in chronic insomnia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ture acupuncture group
After recruiting, patients are assigned to the ture acupuncture group by randomization,and then receive ture acupuncture treatment. patients are scanned by MRI at the baseline and 3 month post-treatment respectively.
Ture acupuncture
Patients receive true acupuncture treatment by Zhoushi coordinated points at the "Bai-hui" (DU20), "Shen-ting" (DU24), bilateral "Ben-shen" (BG13), "Shen-men" (HT7), "San-yin-jiao" (SP6) with "Deqi" sensation. The needles are retained for 20 minutes in every course, three times per week and last for 3 months.
Sham acupuncture group
After recruiting, patients are assigned to the sham acupuncture group by randomization,and then receive sham acupuncture stimulation. patients are scanned by MRI at the baseline and 3 month post-treatment respectively.
Sham acupuncture
Patients receive sham acupuncture stimulation by non-acupoint points (superficial insertion, 0.2 cun, No needle sensation (de qi) is elicited) at the bilateral mid-point between Shuaigu(GB8) and Touwei(ST8), Touwei(ST8) and Yangbai(GB14), front tibia, the junction of biceps and triceps.
Healthy group
Healthy subjects without intervention except scanned brain image by MRI at the baseline.
No interventions assigned to this group
Interventions
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Ture acupuncture
Patients receive true acupuncture treatment by Zhoushi coordinated points at the "Bai-hui" (DU20), "Shen-ting" (DU24), bilateral "Ben-shen" (BG13), "Shen-men" (HT7), "San-yin-jiao" (SP6) with "Deqi" sensation. The needles are retained for 20 minutes in every course, three times per week and last for 3 months.
Sham acupuncture
Patients receive sham acupuncture stimulation by non-acupoint points (superficial insertion, 0.2 cun, No needle sensation (de qi) is elicited) at the bilateral mid-point between Shuaigu(GB8) and Touwei(ST8), Touwei(ST8) and Yangbai(GB14), front tibia, the junction of biceps and triceps.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* control group: no self-reported sleep problems in the last 1 months. PSQI≤5 、SAS\<50、 SDS\<50，MMSE≥27.
* 30-60 years old.
* Male or female.
* Dextromanuality.
* Having given written informed consent to participate in the research project.
Exclusion Criteria
* Other diagnoses of the nerve or mental disorders.
* Other sleep disorders.
* The long history of smoking, drinking and abusing drugs, or taking psychotropic drugs in last month, and treatment in other clinical trials at the same time.
* The body carrying pacemakers, defibrillators, implantable vascular clamp, implantable electric or magnetic device, mechanical heart valve, artificial cochlear, el., fMRI taboo and the claustrophobic.
* MRI scans have been used to identify patients with a definite organic lesion or severe head anatomical asymmetry
* Pregnancy, lactation and peri menopausal women.
* An allergy history of syncope, alcohol, and metal needle.
* The body Mass Index\>32 or \<19.8.
30 Years
60 Years
ALL
Yes
Sponsors
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Beijing Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Ping Zhou
Principal Investigator
Principal Investigators
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Liu cun zhi, M.D
Role: STUDY_DIRECTOR
Beijing Hospital of Traditional Chinese Medicine
Locations
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Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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2016BL-033-01
Identifier Type: -
Identifier Source: org_study_id