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

Insomnia Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03237338
• Other study ID #: 2017-JYB-JS-166
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2020
• Source: Dongfang Hospital Beijing University of Chinese Medicine
• Contact: Ran Pang, doctor
• Phone: 861067693481
• Email: pangrandf[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

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 acupuncture
Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks

Locations

Country	Name	City	State
China	Dongfang Hospital Affiliated to Beijing University of Chinese Medicine	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Dongfang Hospital Beijing University of Chinese Medicine	First Affiliated Hospital Xi'an Jiaotong University, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	brain functional connectivity	functional connectivity between the medial prefrontal cortex and other brain regions	at the 24th day after acupuncture treatment
Secondary	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