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

NCT06604637 | Completed

• 1 other identifier: TTH-VNS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tension-Type Headache

Keywords

Tension-Type Headache; Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (4)

• Pain intensity

  In the headache diary, the severity of the pain will be questioned with a numerical pain scale.

  Change from baseline at 4 weeks

• Pain duration

  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

  The number of days of pain during a month will be questioned in the headache diary.

  Change from baseline at 4 weeks

• Heart rate variability

  Heart rate variability will be measured with an automatic device.

  Change from baseline at 4 weeks

Secondary Outcomes (2)

• Headache Impact Scale

  Change from baseline at 4 weeks

• Depression Anxiety Stress Scale (DASS-21)

  Change from baseline at 4 weeks

Study Arms (2)

VNS Group

EXPERIMENTAL

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)

Control roup

NO INTERVENTION

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

Interventions

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.

VNS Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bitlis Eren Üniversitesi

Bitlis, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)