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

NCT03237338 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-07-09

No results posted yet for this study

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.

Conditions

  • Insomnia Disorder

Interventions

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

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

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • Dongfang Hospital Beijing University of Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-26
Primary Completion
2021-08-20
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03237338 on ClinicalTrials.gov