Tension-Type HeadacheNCT06604637
Effectiveness of Vagus Nerve Stimulation in Individuals With Tension-Type Headache
A study testing Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in people with Tension-Type Headache, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2024to 5 Mar 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with tension-type headache according to the International Classification of Headache Disorders (ICHD-3) criteria,
- Individuals between the ages of 18-65,
Who cannot join
- History of trauma or surgery to the head and neck region,
- Presence of lesions or metal implants in the application area,
- Uncontrolled hypertension/abnormal ECG results/history of myocardial infarction/pacemaker and similar cardiovascular disease history/suspicion,
- Pregnancy or suspicion,
- Other primary and secondary headache types,
- Individuals who received physiotherapy in the last 6 months,
Trial locations and contacts
1 site in 1 country.
About this study
It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache.
Read the detailed description
Tension-type headache is the most common primary headache, usually bilateral, characterized by oppressive and squeezing pain of mild or moderate intensity, unchanged by physical activity. It affects approximately 80% of the population and has a point prevalence of 42% in the general population.
There are various pharmacological and non-pharmacological treatment methods for tension-type headache. One of the non-pharmacological treatment methods may be Vagus Nerve Stimulation (VNS). VNS can affect healing processes by regulating the autonomic nervous system and reduce symptoms in tension-type headache.
- Conditions
- Tension-Type Headache
- Being tested
- Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)
- Keywords
- Tension-Type Headache, Vagus Nerve Stimulation
- 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.
Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)Other
taVNS will be applied for a total of 12 sessions, 20 minutes each session, 3 days/week.
| Study group | Role | What they receive |
|---|---|---|
| VNS Group | Experimental | In addition to standard treatment, noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group. Receives: Other: Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) |
| Control roup | No intervention | The control group will receive standard treatment ( patient education+lifestyle recommendations). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
In the headache diary, the severity of the pain will be questioned with a numerical pain scale.
Measured: Change from baseline at 4 weeks
Pain duration
The duration of pain will be questioned in the headache diary.
Measured: Change from baseline at 4 weeks
Number of days of pain for 1 month
The number of days of pain during a month will be questioned in the headache diary.
Measured: Change from baseline at 4 weeks
Heart rate variability
Heart rate variability will be measured with an automatic device.
Measured: Change from baseline at 4 weeks
Secondary outcomes (2)
Headache Impact Scale
It is a 6-item scale assessing vitality, pain, psychological state, social, role and cognitive function. The total score of the scale varies between 36-78; higher scores indicate a higher level of impact on the quality of life of the individual.
Measured: Change from baseline at 4 weeks
Depression Anxiety Stress Scale (DASS-21)
It evaluates the condition of the individual in the last week. It is a 21-question questionnaire consisting of 3 subscales: depression, anxiety and stress. The questionnaire score ranges from 0 to 21 for each subgroup. High scores indicate the presence and severity of depression, anxiety and stress.
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Arslan, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604637
- Sponsor's protocol ID
- TTH-VNS
- Status last verified
- Mar 2025
- First submitted
- 15 Sep 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vagus Nerve Stimulation in Individuals With Tension-Type Headache
- ClinicalTrials.gov ID
- NCT06604637
- Acronym / sponsor ID
- TTH-VNS
- Conditions
- Tension-Type Headache
- Keywords
- Tension-Type Headache, Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 19 Sep 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.
It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache.
Detailed description
Tension-type headache is the most common primary headache, usually bilateral, characterized by oppressive and squeezing pain of mild or moderate intensity, unchanged by physical activity. It affects approximately 80% of the population and has a point prevalence of 42% in the general population.
There are various pharmacological and non-pharmacological treatment methods for tension-type headache. One of the non-pharmacological treatment methods may be Vagus Nerve Stimulation (VNS). VNS can affect healing processes by regulating the autonomic nervous system and reduce symptoms in tension-type headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VNS Group | Experimental | Other: Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)In addition to standard treatment, noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group. |
| Control roup | No intervention | –The control group will receive standard treatment ( patient education+lifestyle recommendations). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals with tension-type headache according to the International Classification of Headache Disorders (ICHD-3) criteria,
- Individuals between the ages of 18-65,
Key exclusion criteria (6 listed)
- History of trauma or surgery to the head and neck region,
- Presence of lesions or metal implants in the application area,
- Uncontrolled hypertension/abnormal ECG results/history of myocardial infarction/pacemaker and similar cardiovascular disease history/suspicion,
- Pregnancy or suspicion,
- Other primary and secondary headache types,
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 |
|---|---|---|
| Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)taVNS will be applied for a total of 12 sessions, 20 minutes each session, 3 days/week. | Other | VNS Group |
Primary outcome
Pain intensity
Time frame: Change from baseline at 4 weeks
In the headache diary, the severity of the pain will be questioned with a numerical pain scale.
Pain duration
Time frame: Change from baseline at 4 weeks
The duration of pain will be questioned in the headache diary.
Number of days of pain for 1 month
Time frame: Change from baseline at 4 weeks
The number of days of pain during a month will be questioned in the headache diary.
Heart rate variability
Time frame: Change from baseline at 4 weeks
Heart rate variability will be measured with an automatic device.
2 secondary outcomes
Headache Impact Scale
Time frame: Change from baseline at 4 weeks
Depression Anxiety Stress Scale (DASS-21)
Time frame: Change from baseline at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in people with Tension-Type Headache, run by Bitlis Eren University at 1 site 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Change from baseline at 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 11 Mar 2025.