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

March 7, 2025 updated by: Mesut Arslan, Bitlis Eren University
It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bitlis, Turkey
        • Bitlis Eren Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VNS Group
In addition to standard treatment, noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group.
Other: 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.
No Intervention: Control roup
The control group will receive standard treatment ( patient education+lifestyle recommendations).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 4 weeks
Heart rate variability
Time Frame: Change from baseline at 4 weeks
Heart rate variability will be measured with an automatic device.
Change from baseline at 4 weeks
Pain duration
Time Frame: Change from baseline at 4 weeks
The duration of pain will be questioned in the headache diary.
Change from baseline at 4 weeks
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.
Change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 4 weeks
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.
Change from baseline at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitlis Eren University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Actual)

March 5, 2025

Study Completion (Actual)

March 5, 2025

Study Registration Dates

First Submitted

September 15, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTH-VNS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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