Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study

Beijing Hospital of Traditional Chinese Medicine

Status: Unknown

Conditions: Chronic Insomnia

Treatments: Device: Sham acupuncture; Device: Ture acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03386903

2016BL-033-01

Details and patient eligibility

About

The purpose of the study is to investigate the underlying central nervous mechanisms of acupuncture treatment in chronic insomnia patients, from observation changes of gray matter and functional connectivity in the default mode network and the salience network by functional magnetic resonance imaging, and combine with clinical efficacy assessment to analyze the association between the results of imaging and behavioristic.

Full description

Chronic insomnia which can cause daytime function impairments like abnormal emotion and hypomnesis is important risk factors for developing cardiovascular disease, neurological disorders or mental disorders. Acupuncture is a widely recognized therapy to treat chronic insomnia in clinical practice. Previous researches presented that sleep-wake dysfunction of patients with chronic insomnia have strong correlation with abnormal of the default mode network and salience network. The project present acupuncture may improve sleep quality by adjusting the abnormal default mode network and the salience network in patients with chronic insomnia.

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Insomnia group: Patients must meet DSM V criteria for chronic insomnia. PSQI>7 、ISI>7、 SAS<50、 SDS<50.
• 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

• History of cardiovascular and respiratory diseases.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Ture acupuncture group

Experimental group

Description:

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.

Treatment:

Device: Ture acupuncture

Sham acupuncture group

Placebo Comparator group

Description:

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.

Treatment:

Device: Sham acupuncture

Healthy group

No Intervention group

Description:

Healthy subjects without intervention except scanned brain image by MRI at the baseline.