Study the Effect of Acupuncture on Migraine Patient Without Aura Via Functional Magnetic Resonance Imaging.
Primary Purpose
Migraine Without Aura
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Migraine Without Aura focused on measuring Acupuncture, Functional magnetic resonance imaging
Eligibility Criteria
Inclusion Criteria:
- Fitting to the standard of migraine without aura in the international classification of headache disease (ICHD-2) issued by the international headache society in 2004.
- Age from 18 to 55, male or female, with right-handedness.
- Having no depression or other serious mental illness.
- Having no psychoactive drugs taken in the past 3 months, or vasoactive drugs in the past 2 weeks.
- Having no habit of taking analgesics from a long time.
Exclusion Criteria:
- Having the first headache attack of migraine after 55 years old.
- Having a history of head injury, cluster headache, or other unclassified headaches.
- Taking medicine to prevent migraine in recent 4 weeks.
- Having the serious asymmetry or definite pathological changes in the anatomical structure of the head through the MRI scan.
- Cannot hold on the times of the MRI scan.
Sites / Locations
- Dongzhimen Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Long term course of migraine patient without aura
Short term course of migraine patient without aura
Arm Description
Patients in this group have the history of migraine without aura more than 5 years.
Patients in this group have the history of migraine without aura equal or less than 5 years.
Outcomes
Primary Outcome Measures
Headache Intensity
The headache intensity is measured by the value of Visual Analogue Scale which limits 1 to 10. The higher value of this scale represents the worse headache.
Headache Days
The days when headache attacked. The increased day represents the worse headache.
Headache Frequency
The maximum times in one day during the headache attacked. The increased time represents the worse headache.
Dataset of functional magnetic resonance imaging on brain
Dataset of functional magnetic resonance imaging on brain includes functional images, structural images and diffusion tensor images.
Secondary Outcome Measures
Pittsburgh Sleep Quality Index
One of the clinical measurement. The higher value represents the worse quality of sleep.
Medical Outcomes Study Short-Form 36 questionnaire
One of the clinical measurement. The value range is 0 to 10, the higher value represents the better quality of life.
Full Information
NCT ID
NCT04636359
First Posted
November 4, 2020
Last Updated
November 19, 2020
Sponsor
Beijing University of Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04636359
Brief Title
Study the Effect of Acupuncture on Migraine Patient Without Aura Via Functional Magnetic Resonance Imaging.
Official Title
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study recruits 30 subjects into three groups, including two experimental groups and one control group. The two experimental groups receive acupuncture treatment for 4 weeks and two times functional magnetic resonance imaging scans as well as clinical symptom assessments. The control group receive one scan without any intervention. The aim of this study is to find the whether the effect of acupuncture treatment have diversity among migraineurs with different disease course.
Detailed Description
This study recruits 10 patients with long course (> 5 years) without aura migraine, 10 patients with short course (< 5 years) without aura migraine and 10 healthy volunteers who meet the inclusion and exclusion criteria. Among the study, two migraine patient groups receive acupuncture treatment for 4 weeks, the frequency is 30 minutes each time, three times a week. According to the national standard of the people's Republic of China (GB / T 12346-2006) acupoint name and location, the acupuncture treatment includes SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral) acupoints. Both migraine patients receive scan in functional magnetic resonance imaging (Siemens 3.0T superconducting magnetic resonance scanner, Germany) and symptom scale assessment before the first acupuncture stimulation and post the last acupuncture stimulation. Healthy volunteers receive only one scanning without intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura
Keywords
Acupuncture, Functional magnetic resonance imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two experimental groups with different condition receive identical intervention, with control group as baseline for comparison.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Long term course of migraine patient without aura
Arm Type
Experimental
Arm Description
Patients in this group have the history of migraine without aura more than 5 years.
Arm Title
Short term course of migraine patient without aura
Arm Type
Experimental
Arm Description
Patients in this group have the history of migraine without aura equal or less than 5 years.
Intervention Type
Behavioral
Intervention Name(s)
Acupuncture stimulation
Intervention Description
The intervention is about acupuncture treatment, which has 4 weeks acupoint stimulation and the frequency is 30 minutes each times for 3 times per week. The acupoints include SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral).
Primary Outcome Measure Information:
Title
Headache Intensity
Description
The headache intensity is measured by the value of Visual Analogue Scale which limits 1 to 10. The higher value of this scale represents the worse headache.
Time Frame
Change from Visual Analogue Scale at 1 months.
Title
Headache Days
Description
The days when headache attacked. The increased day represents the worse headache.
Time Frame
Change from the number of day at 1 months.
Title
Headache Frequency
Description
The maximum times in one day during the headache attacked. The increased time represents the worse headache.
Time Frame
Change from the times of headache attack at 1 months.
Title
Dataset of functional magnetic resonance imaging on brain
Description
Dataset of functional magnetic resonance imaging on brain includes functional images, structural images and diffusion tensor images.
Time Frame
Changes from the dataset of subject's brain area at 1 months.
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
One of the clinical measurement. The higher value represents the worse quality of sleep.
Time Frame
Change from the value of Pittsburgh Sleep Quality Index at 1 months.
Title
Medical Outcomes Study Short-Form 36 questionnaire
Description
One of the clinical measurement. The value range is 0 to 10, the higher value represents the better quality of life.
Time Frame
Change from the value of Medical Outcomes Study Short-Form 36 questionnaire at 1 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fitting to the standard of migraine without aura in the international classification of headache disease (ICHD-2) issued by the international headache society in 2004.
Age from 18 to 55, male or female, with right-handedness.
Having no depression or other serious mental illness.
Having no psychoactive drugs taken in the past 3 months, or vasoactive drugs in the past 2 weeks.
Having no habit of taking analgesics from a long time.
Exclusion Criteria:
Having the first headache attack of migraine after 55 years old.
Having a history of head injury, cluster headache, or other unclassified headaches.
Taking medicine to prevent migraine in recent 4 weeks.
Having the serious asymmetry or definite pathological changes in the anatomical structure of the head through the MRI scan.
Cannot hold on the times of the MRI scan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Ren, Doctor
Organizational Affiliation
Dongzhimen Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongzhimen Hospital
City
Beijing
ZIP/Postal Code
100007
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data of this study includes two aspect, data of brain scans and data of clinical symptom scales. The latter data will be shared to other researchers who contact us via email. The former data, however, is a DICOM format data that hard to analysis in non specialists. Besides, the size of DICOM data is much big that we haven't enough funding to support it in website. Thus, we haven't decided to share this kind of dataset. Except for those data, other data within our study is willing to be share.
Our email: clancy_wu@bucm.edu.cn; clancy_wu@126.com; clancy.wu94@gmail.com.
Learn more about this trial
Study the Effect of Acupuncture on Migraine Patient Without Aura Via Functional Magnetic Resonance Imaging.
We'll reach out to this number within 24 hrs