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

Not Applicable

Completed

• Conditions: Tension-Type Headache

• 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

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