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

NCT ID: NCT06604637

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-03-05

Brief Summary

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

Detailed Description

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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

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Tension-Type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VNS Group

In addition to standard treatment, noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group.

Group Type EXPERIMENTAL

Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS)

Intervention Type OTHER

taVNS will be applied for a total of 12 sessions, 20 minutes each session, 3 days/week.

Control roup

The control group will receive standard treatment ( patient education+lifestyle recommendations).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitlis Eren University

OTHER

Sponsor Role lead

Responsible Party

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Mesut Arslan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bitlis Eren Üniversitesi

Bitlis, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TTH-VNS

Identifier Type: -

Identifier Source: org_study_id

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