Tension-Type Headache, Unspecified, IntractableTTHNCT06562855
Tension-Type Headache Gene Expression and Methylation
A study testing Peripheral blood sampling in people with Tension-Type Headache, Unspecified, Intractable, run by University of Gaziantep at 2 sites in Turkey (Türkiye).
Trial summary
Tension-type headache (TTH) refers to pain radiating from the forehead to the back of the head as a bilateral band. It often occurs without warning and spreads to the neck muscles. Patients describe it as tension, pressure, or dull pain. It is usually triggered by stress. Read more about this study
- Who is it for?
- Ages 17 to 82 years
- Conditions the study is for
- Tension-Type Headache, Unspecified, Intractable
- What is being tested?
- Peripheral blood sampling
- How many people
- Not given
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 82 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- (ICHD)-3 criteria
- Male and female
- 17-82 years
- not diagnosed with tension-type or other primary headaches
Who cannot join
- Tension-type headache not diagnosed
- below 16 ages
- pregnant woman
- subdural hematoma
- intracranial mass
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
- Available
Gaziantep University Şahinbey Research and Application Hospital
Gaziantep, Şehitkamil, 27310
- Available
Medicine
Gaziantep, Şehitkamil, 27310
Şenay Görücü Yılmaz, PhD, +903423601200, gorucu@gantep.edu.tr
Sırma Geyik, MD, +903423606060, geyiks@gmail.com
About this study
Official title: Gene Expression-methylation Profiling
Tension-type headache (TTH) refers to pain radiating from the forehead to the back of the head as a bilateral band. It often occurs without warning and spreads to the neck muscles. Patients describe it as tension, pressure, or dull pain. It is usually triggered by stress. The complexity of the processes is the biggest difficulty in diagnosing and treating TTH. Although there are genetic connections, there are no single responsible genes.
Read the detailed description
130 TTH patients and 117 healthy controls were included in the study. Serum markers of the patients were measured. WNT5A, responsible for the Wnt-B catenin signaling pathway, and its receptor FZD3 were examined in the pathogenesis of TTH. Expression changes and methylation profiles of genes were obtained. Genetic and serum parameters were compared. Diagnostic powers were determined by ROC analyses.
- Being tested
- Peripheral blood sampling
- Keywords
- Tension-Type Headache, Gene expression, Gene methylation
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood samplingGenetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type Headache, Unspecified, IntractableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şenay Görücü Yılmaz, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562855
- Sponsor's protocol ID
- GaziantepUniversity
- Acronym
- TTH
- Status last verified
- Aug 2024
- First submitted
- 13 May 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression-methylation Profiling
- ClinicalTrials.gov ID
- NCT06562855
- Acronym / sponsor ID
- TTH / GaziantepUniversity
- Keywords
- Tension-Type Headache, Gene expression, Gene methylation
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tension-type headache (TTH) refers to pain radiating from the forehead to the back of the head as a bilateral band. It often occurs without warning and spreads to the neck muscles. Patients describe it as tension, pressure, or dull pain. It is usually triggered by stress. The complexity of the processes is the biggest difficulty in diagnosing and treating TTH. Although there are genetic connections, there are no single responsible genes.
Detailed description
130 TTH patients and 117 healthy controls were included in the study. Serum markers of the patients were measured. WNT5A, responsible for the Wnt-B catenin signaling pathway, and its receptor FZD3 were examined in the pathogenesis of TTH. Expression changes and methylation profiles of genes were obtained. Genetic and serum parameters were compared. Diagnostic powers were determined by ROC analyses.
Study design
Who may qualify
- Ages
- 17 to 82 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- (ICHD)-3 criteria
- Male and female
- 17-82 years
- not diagnosed with tension-type or other primary headaches
Key exclusion criteria (5 listed)
- Tension-type headache not diagnosed
- below 16 ages
- pregnant woman
- subdural hematoma
- intracranial mass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood sampling | Genetic | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral blood sampling in people with Tension-Type Headache, Unspecified, Intractable, run by University of Gaziantep at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şenay Görücü Yılmaz, PhD (+903423601200, gorucu@gantep.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024; AzTrials last refreshed its copy on 28 Oct 2026.