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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Insomnia
• Intervention / Treatment: Device: Ture acupuncture; Device: Sham acupuncture

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu c zhi, M.D; Phone Number: 010-52176043; Email: lcz623780@126.com
• Study Contact Backup: Name: zhou ping, Postgraduate Student; Phone Number: 13261306969; Email: hzyyzp@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.; Other Names: Experimental
PLACEBO_COMPARATOR: 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.	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.; Other Names: Placebo Comparator
NO_INTERVENTION: Healthy group; Healthy subjects without intervention except scanned brain image by MRI at the baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality obtained by questionnaire:Pittsburgh Sleep Quality Index	Change in Pittsburgh sleep quality index scores at the baseline and the end of 12 weeks stimulation with acupuncture.Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)	baseline,12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain gray matter	The changes of gray matter volume in default network before and after treatment	baseline,12 weeks
Total sleep time obtained by questionnaire:Pittsburgh Sleep Quality Index		baseline,12 weeks
Sleep efficiency obtained by questionnaire:Pittsburgh Sleep Quality Index		baseline,12 weeks
Sleep latency obtained by questionnaire:Pittsburgh Sleep Quality Index		baseline,12 weeks
Wake after sleep onset obtained by questionnaire:Pittsburgh Sleep Quality Index		baseline,12 weeks
Sleep problem obtained by questionnaire:Insomnia Severity Index		baseline,12 weeks
Emotional state of anxiety obtained by questionnaire:Self-Rating Anxiety Scale		baseline,12 weeks
Emotional state of depression obtained by questionnaire:Self-Rating Depression Scale		baseline,12 weeks
Daytime function obtained by questionnaire:Epworth Sleepiness Score		baseline,12 weeks
Daytime function obtained by questionnaire:Flinders Fatigue Scale		baseline,12 weeks
resting-state functional magnetic resonance imaging	Resting state intrinsic connectivity within the default network by MRI	baseline,12 weeks

Collaborators and Investigators

• Sponsor: Beijing Hospital of Traditional Chinese Medicine
• Investigators: Study Director: Liu cun zhi, M.D, Beijing Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 28, 2018
• Primary Completion (ANTICIPATED): December 28, 2018
• Study Completion (ANTICIPATED): June 28, 2019

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (ACTUAL): December 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2016BL-033-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No