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

Not Applicable

Completed

• Conditions: Tension-Type Headache
• Interventions: Other: Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)

• Registration Number: NCT06604637
• Lead Sponsor: Bitlis Eren University

Brief Summary

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 Timeline

• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Study Start: 2024-09-30
• Status Verified: 2025-03
• Primary Completion: 2025-03-05
• Study Completion: 2025-03-05
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VNS Group	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.

Primary Outcome Measures

Name	Time	Method
Pain intensity	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	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	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	Change from baseline at 4 weeks	Heart rate variability will be measured with an automatic device.

Secondary Outcome Measures

Name	Time	Method
Headache Impact Scale	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.
Depression Anxiety Stress Scale (DASS-21)	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.

Trial Locations

Locations (1)

Bitlis Eren Üniversitesi; 🇹🇷 Bitlis, Turkey