The Study of Mechanism of Chronic Insomnia Disorder Using Acupuncture Based on Changes of Brain GABA and fMRI

The Study of Brain GABA and Brain Functional Modulatory Mechanism of Chronic Insomnia Disorder Using Acupuncture at "Combined Magical-door" Acupoints

Insomnia disorder is one of the major neuropsychiatric diseases which received more attention in recent years. Disturbances in the amino acid neurotransmitter, gama-amino butyric acid (GABA) and hyperarousal of cortex are hypothesized to contribute to the neurobiology of insomnia. Both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on insomnia symptom. However, the underlying mechanism remains unclear. The principal objective of this project is to use magnetic resonance spectroscopy (MRS) as well as acupuncture to provide the first in vivo characterization of cortical GABA levels between pro- and post-acupuncture treatment in individuals with chronic insomnia disorder (CID), and use resting state functional magnetic resonance imaging (fMRI) to determine whether CID patients have altered brain connectivity and network parameter changes. The investigators are also exploring the correlation between cortical GABA levels, fMRI parameter changes and abnormalities in sleep parameters and neuropsychology test in CID patients.

Study Overview

• Status: Unknown
• Conditions: Insomnia Disorder
• Intervention / Treatment: Procedure: ture acupuncture; Procedure: sham acupuncture

Detailed Description

Three groups of subjects (CID accepted true acupuncture, CID accepted sham acupuncture and healthy) will participate in the study. All subjects will undergo a laboratory blood test, physical and neurological examination, polysomnography (PSG) and an extensive battery of neuropsychological assessments. All subjects meeting eligibility criteria for the study will complete a baseline MRS and fMRI to evaluate differences in multi-modality brain GABA and fMRI parameters between the patients and healthy. After randomized acupuncture treatment, investigators will compare brain metabolic and functional parameters to elucidate the neural mechanism of acupuncture therapy on insomnia, provide theoretical evidence from the perspective of neurotransmitters and brain network.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ran Pang, doctor; Phone Number: 861067693481; Email: pangrandf@163.com
• Study Contact Backup: Name: Li Zhang; Phone Number: 861067689644; Email: zhanglidf2017@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
    • Contact: Li Zhang, MD; Phone Number: 861067689644

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of chronic insomnia disorder (CID) met the criteria of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Subject has history of chronic insomnia (difficulty with sleep induction, awakenings during the night, early morning awakening) of at least 3 months
• Must be able to cooperate with cognitive testing and MRI scan

Exclusion Criteria:

• Known pre-existing sleep disorder other than chronic insomnia disorder
• Circadian rhythm sleep disorder determined by sleep-wake cycles of sleep (such as work time at day and night alternation)
• Severe general medical disorders of cardiovascular, endocrine, renal, or hepatic systems
• Clinical diagnosis of AD or Parkinson's neurodegenerative diseases
• Moderate or severe psychological illness
• Clinical history of stroke or other severe cerebrovascular disease
• Clinical history of malignancies disease
• Active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon)
• Alcohol or drug abuse

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Insomnia-ture acupuncture; True acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture	Procedure: ture acupuncture; ture acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks
SHAM_COMPARATOR: Insomnia-sham acupuncture; Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture	Procedure: sham acupuncture; Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline brain GABA level at 24 days	GABA levels in the prefrontal gyrus, occipital gyrus	at the 2 day before acupuncture treatment and the 24th day after acupuncture treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
brain functional connectivity	functional connectivity between the medial prefrontal cortex and other brain regions	at the 24th day after acupuncture treatment
Wake time after sleep onset (WASO)	WASO is the total time of awake occurring between sleep onset and final wake up	at the 24th day after acupuncture treatment

Collaborators and Investigators

• Sponsor: Dongfang Hospital Beijing University of Chinese Medicine
• Collaborators: First Affiliated Hospital Xi'an Jiaotong University; Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 26, 2017
• Primary Completion (ANTICIPATED): August 20, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 30, 2017
• First Posted (ACTUAL): August 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: August 1, 2020

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: 2017-JYB-JS-166

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No