China HeadAche DIsorders RegiStry

Migraine Clinical Trial

— CHAIRS  

Official title:

China HeadAche DIsorders RegiStry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05334927
• Other study ID #: KY2022-tt02
• Status: Not yet recruiting
• Start date: August 29, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: June 2022
• Source: Beijing Tiantan Hospital
• Contact: Yong Gang Wang, Doctor
• Phone: 15010066622
• Email: w100yg[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

It is planned to include 10000 patients. In the China HeadAche DIsorders RegiStry CHAIRS）, patients aged over 12 years with primary headache and medication-overuse headache(MOH) were collected. The biomarkers, imaging features, cognition, genetic characteristics, ocial and demographic data, medical data, therapeutics used, and outcome of headache-related diseases were studied, and long-term follow-up was planned.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Age = 12 years old,Any gender;

2. The first onset age of primary headache was less than 50 years old(Age <65 years at first diagnosis of chronic migraine);

3. patients with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3;

4. Sign the informed consent form.

Exclusion Criteria:

1. According to the ICHD-3 diagnostic criteria, there are still headaches directly related to secondary factors (except drug overuse) at the time of enrollment;

2. Those who cannot be diagnosed as primary headache or primary headache combined with medication overuse headache according to ICHD-3;

3. According to DSM-V diagnostic criteria, patients with severe mental diseases (such as schizophrenia, mental disorders associated with mental retardation, etc.);

4. Patients with severe organic diseases, such as malignant tumors, and the expected survival time is less than 1 year;

5. Pregnant,planning pregnancy or Lactating women;

6. Subjects participating in other clinical trials;

7. Unable to cooperate to complete the follow-up due to geographical or other reasons

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Headache Disorders, Secondary
• Medication Overuse Headache
• Migraine
• New Daily Persistent Headache
• Tension-Type Headache

Intervention

Behavioral:
• Medicine Overuse Headache/New Daily Persistent Headache
At the end of the 24th month visit, the patient is free to choose whether to conduct a face-to-face visit once a year until death.
• Chronic Migraine
long-term follow-up
• Patients with other types of primary headache
No collection Brain imaging?Cognitive function test?Biological sample

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Days	The number of days of headache is the number of days in which headache occurs.	long term: 10 years
Primary	MRI change	Patients will accept MRI scans will be done at baseline and once per year.	long term: 10 years
Primary	Genetic analysis of familial headache	Blood samples will be collected from all participants who consent to participate in the study, for the purposes of genetic analysis of familial headache.	1 year
Primary	Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) will be used to assess changes in cognitive functions.	long term: 10 years
Primary	Mini-Mental State Exam (MMSE)	The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used in clinical and research settings to assess cognitive function.	long term: 10 years
Primary	Migraine Disability Assessment (MIDAS)	The MIDAS is a 7-item questionnaire designed to quantify headache-related disability over a 3- month period. The MIDAS score is the sum of missed work or school days, days at work or school plus days of household work where productivity was reduced by half or more, missed household work days, and missed non-work activity days due to headaches in the last 3 months.	long term: 10 years
Primary	Generalized Anxiety Disorder (GAD-7)	GAD-7 is a proven, self-administered and concise tool for screening and diagnosing mental health disorders, which has been tested in the field in office practice. The GAD-7 scale score ranges from 0 to 21.	long term: 10 years
Primary	Patient Health Questionnaire (PHQ)-9	The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.	long term: 10 years
Secondary	Social and demographic data, medical history	Social and demographic data, medical and medication history will be collected at initial screening.	long term: 10 years
Secondary	Use of Rescue Medication	Frequency of Rescue medication will be collected by eDiary.	long term: 10 years
Secondary	Moderate / Severe Headache Days	Moderate / severe headache days are defined as a day in which moderate or severe pain persists for at least 4 hours, or headache lasts for one day after successful medication for acute headache. These definitions allow the use of relatively simple headache diaries. Subjects were required to indicate whether headache was present (yes / no), peak (mild / moderate / severe) severity and duration (< 4h or 4h), type of acute drug intake, and response to treatment should also be recorded.	long term: 10 years
Secondary	Pain severity	Pain severity were captured through Visual analogue scale (VAS) for pain, a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).	long term: 10 years
Secondary	MEG	Patients will accept MEG.	long term: 10 years
Secondary	PET	Patients will accept PET scan.	long term: 10 years
Secondary	EEG	Patients will accept EEG scan.	long term: 10 years
Secondary	Proteomics	Blood, urine and Cerebrospinal fluid samples will be collected from all participants who consent to participate in the study, for the purposes of Proteomics at baseline and month 12.	1 year
Secondary	Microbiome	Saliva samples will be collected from all participants who consent to participate in the study, for the purposes of Microbiome at baseline and month 12.	1 year
Secondary	Headache Impact Test (HIT-6)	The HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function.	long term: 10 years
Secondary	European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)	EQ-5D-3L is a generic instrument for use as a measure of health status. The EQ-5D-3L consists of 2 components-the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.; The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labelled "Best imaginable health state" and "Worst imaginable health state." The scoring range of the EQ VAS is from 0 (worst imaginable health) to 100 (best imaginable health).	long term: 10 years
Secondary	Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1)	The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive assesses how migraines limit one's daily social and work-related activities; Role Function Preventive assesses how migraines prevent these activities; and the Emotional Function domain assesses the emotions associated with migraines.	long term: 10 years
Secondary	Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep.	long term: 10 years
Secondary	Columbia-Suicide Severity Rating Scale	C-SSRS will be administered to study subjects at each study visit to assess possible suicidal ideation and behavior. Reports of suicidal ideation with intent to act (endorse item 4 or 5) and reports of actual, aborted, or interrupted suicide attempts or a behavior preparatory for making an attempt indicate subjects at high risk for suicide.	long term: 10 years