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Salivary Inflammatory Markers in Tension Type Headache and Migraine (SalHead)

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ClinicalTrials.gov Identifier: NCT03727672
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Anastasia Bougea, National and Kapodistrian University of Athens

Brief Summary:
Data role of salivary inflammatory markers in migraine and Tension Type headache (TTH) are lacking. Τhe investigators studied whether headache attacks are associated with changes in C reactive protein (CRP), Interleukin -1β and Interleukin -6 in saliva in patients with Tension Type Headache and Migraine and age matched healthy controls . Τhe investigators, also investigated whether these markers could be influenced by comorbidities such as depression and anxiety.

Condition or disease
Migraine Tension-Type Headache

Detailed Description:

Sixty subjects of both genders, aged from 18 to 60 years old, with primary headaches TTH and migraine, according to the International Classification of Headache Disorders, 3rd edition (beta version), were enrolled from the outpatient headache clinic of University Hospital of Athens between January to March 2016. 30 healthy control subjects aged matched were recruited mainly from hospital staff and patients' relatives.

Initially, the participants completed the Hamilton Anxiety (HAM-A), Scale Beck Depression Inventory (BDI). All patients had to keep a headache diary during the four-week run-in period. All headache suffers were instructed to collected salivary headache-free baseline samples at the time of study screening when they had been free of headache for at least 48 hours (time point A). All headache suffers collected additional samples during moderate/severe headache (time point B), and at self-defined resolution phase 24 hours of their headache attack (time point C). Healthy control subjects were instructed to collected samples at the time of study screening (time point D). Every week, until four weeks and one month after the end of the study, participants were contacted, in order to ensure the compliance and the appropriate use of the technique. One year later longitudinal data would also be obtain.

Saliva Sample Collection Detailed instructions for the correct collection of saliva samples were given to all participants. Such instructions include avoiding eating a major meal and teeth brushing 60 minutes prior to sample collection. Also consumption of high sugar and caffeine content foods as well as high acidity foods have to be excluded before saliva sample collection. Mouth rinse with water in order to remove any food residue and saliva sample collection at least 10 minutes after mouth rinse was recommended. Unstimulated whole saliva that pooled on the mouth floor were collected from patients and healthy volunteers in high quality polypropylene vials by the passive drool technique. Finally, all samples were stored in a plastic container at 2-4 ° C until analysis. Saliva was collected from the participants, at 8.00 a.m. in the morning in order to rule out any confounding factor caused by circadian rhythm.

Sample Analysis Morning samples were kept in the refrigerator at 4°C and at the end of the day were brought to the laboratory where they were centrifuged 3000 rpm at 4°C and the supernatant was aliquoted in to polypropylene Cryogenic vials. Vials were frozen in -80°C until analyzed. Saliva transferrin levels were measured by competitive immunoassay kits and Interleukin-6, Interleukin-1β and CRP levels were measured by sandwich ELISA kits. Transferrin levels were used as a screening tool for the presence of blood in saliva samples and samples with transferrin values greater than 1 mg/dl were considered as candidates for exclusion in other salivary assays. Cortisol assay has a sensitivity of < 0.007 μg/ml and an inter-assay coefficient of variation of < 11% while these characteristics are 0.07 pg/ml and 8 for Interleukin-6, 0.37 pg/ml and 7 for Interleukin-1β, 10 pg/ml and 11.2 for CRP as well as 0.08 mg/dl and 7.2 for transferrin respectively.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Salivary Inflammatory Markers (Interleukin -1β, Interleukin -6, C- Reactive Protein) in Tension Type Headache and Migraine
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Group/Cohort
Tension type headache patients
30 subjects of both genders, aged from 18 to 60 years old, with primary headaches (TTH) , according to the International Classification of Headache Disorders, 3rd edition (beta version) , were enrolled from the outpatient headache clinic of the first Neurological Hospital of University of Athens between January to March 2016.
Migraine patients
30 subjects of both genders, aged from 18 to 60 years old, with migraine, according to the International Classification of Headache Disorders, 3rd edition (beta version) , were enrolled from the outpatient headache clinic of the first Neurological Hospital of University of Athens between January to March 2016.
age matched controls
30 healthy control subjects aged matched were recruited mainly from hospital staff and patients' relatives



Primary Outcome Measures :
  1. migraine/Tension type Headache and C reactive protein [ Time Frame: 2 years ]
    establish whether attacks of migraine and Tension type Headache are associated with changes in the concentration of C reactive protein

  2. migraine/Tension type Headache and Interleukin -1β [ Time Frame: 2 years ]
    establish whether attacks of migraine and Tension type Headache are associated with changes in the concentration of Interleukin-1β

  3. migraine/Tension type Headache and Interleukin-6 levels [ Time Frame: 2 years ]
    establish whether attacks of migraine and Tension type Headache are associated with changes in the concentration of Interleukin-6 levels


Secondary Outcome Measures :
  1. C reactive protein concentrations [ Time Frame: 2 years ]
    C reactive protein concentrations as assessed using sandwich ELISA kits

  2. Interleukin-1β concentrations [ Time Frame: 2 years ]
    Interleukin-1β concentrations as assessed using sandwich ELISA kits

  3. Interleukin-6 levels concentrations [ Time Frame: 2,5 years ]
    Interleukin-6 levels concentrations as assessed using sandwich ELISA kits

  4. Anxiety [ Time Frame: 2,5 years ]
    Anxiety as assessed using the Hamilton Anxiety (HAM-A)

  5. Depression [ Time Frame: 2,5 years ]
    Depression as assessed using the Beck Depression Inventory (BDI)


Biospecimen Retention:   Samples Without DNA
Saliva transferrin levels were measured by competitive immunoassay kits and Interleukin-6, Interleukin-1β and CRP levels were measured by sandwich ELISA kits.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects of both genders, aged from 18 to 60 years old, with primary headaches TTH and migraine, according to the International Classification of Headache Disorders, 3rd edition (beta version), were enrolled from the outpatient headache clinic of the first Neurological Hospital of University of Athens between January to March 2016. Fifteen healthy control subjects aged matched were recruited mainly from hospital staff and patients' relatives
Criteria

Inclusion Criteria:

  • aged from 18 to 60 years old
  • Tension type Headache (TTH) and migraine, fulfilling the criteria International Classification of Headache Disorders, 3rd edition (beta version)

Exclusion Criteria:

  • abnormal plasma CRP, Interleukin-1β and Interleukin-6 levels (>10 mg/L)
  • smoking cigarettes > 1 pack/day;
  • current pregnancy, lactation, or hormonal contraceptive use
  • alcohol or substance abuse
  • drug use such as anticoagulants, statins, or hormonal drugs
  • anti-inflammatory therapy
  • other primary or secondary headaches
  • major psychiatric disease
  • oral health problems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727672


Contacts
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Contact: Evangelia Kararizou, Professor 00302107289268 ekarariz@med.uoa.gr

Locations
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Greece
Eginition Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece Recruiting
Athens, Greece, 11528
Contact: EVANGELIA KARARIZOU    00302107289268    ekarariz@med.uoa.gr   
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: ANASTASIA BOUGEA, PHD National and Kapodistrian University of Athens

Publications of Results:
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Responsible Party: Anastasia Bougea, Clinical Researcher, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03727672     History of Changes
Other Study ID Numbers: 638/5.11.2015
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: database

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anastasia Bougea, National and Kapodistrian University of Athens:
Primary headaches
CRP
Interleukin1β
Interleukin6
markers
Additional relevant MeSH terms:
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Migraine Disorders
Tension-Type Headache
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms