NCT03386903

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

Acupuncture Regulates Emotion-cognitive Network of Chronic Insomnia Patients : A DTI-fMRI Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Beijing Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2018-02-28
• Primary completion: 2018-12-28
• Completion: 2019-06-28
• First posted: 2017-12-29
• Last updated: 2017-12-29

Locations

1 site across 1 country: China