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Completed

NCT Number: NCT06604637

Effectiveness of Vagus Nerve Stimulation in Individuals With Tension-Type Headache

It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache.

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Key information

Conditions

Tension-type Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bitlis Eren Üniversitesi

Bitlis, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with tension-type headache according to the International Classification of Headache Disorders (ICHD-3) criteria,
  • Individuals between the ages of 18-65,

Exclusion criteria

  • 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,

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Pain duration

    Time frame: Change from baseline at 4 weeks

    The duration of pain will be questioned in the headache diary.

  3. 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.

  4. Heart rate variability

    Time frame: Change from baseline at 4 weeks

    Heart rate variability will be measured with an automatic device.

Secondary outcomes

  1. Headache Impact Scale

    Time frame: Change from baseline at 4 weeks

    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.

  2. Depression Anxiety Stress Scale (DASS-21)

    Time frame: Change from baseline at 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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