Compare the Effectiveness of nVNS and TENS on Pain and Quality of Life in Patients of Migraine

NCT ID: NCT07055776

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-17
• Study Completion Date: 2026-02-28

Brief Summary

Migraine is a genetically influenced complex neurological disorder characterized by episodes of moderate-to-severe headaches, typically unilateral and frequently accompanied by nausea and heightened sensitivity to light and sound. The common type of migraine headaches is migraine without aura. Migraine has an approximate prevalence of 14.7%, making it the third most common disease in the world. This study aims to compare the effectiveness of non-invasive vagus nerve stimulation (nVNS) and non-invasive transcutaneous electrical nerve stimulation (TENS) in managing pain and improving quality of life (QOL) in patients with migraine.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

non-invasive vagus nerve stimulation (nVNS)

Group Type: EXPERIMENTAL

non-invasive vagus nerve stimulation (nVNS)

Intervention Type: COMBINATION_PRODUCT

Group 1 will receive non-invasive vagus nerve stimulation (nVNS) targeting the auricular branch of the vagus nerve (ABVN) using a TENS device with specialized ear clip electrodes. The electrodes will be placed on the cymba conchae or tragus region of the ear, where the ABVN is accessible. The stimulation parameters will be set to a frequency of 1 Hz (significantly reduced migraine headache), pulse width of 200-300 µs, and intensity adjusted to a strong but comfortable level without causing pain, applied for 15-30 minutes per session, 5 days a week for 12 weeks, based on protocols supported by evidence from studies such as Badran et al. (2018) and Yakunina et al. (2017), which demonstrated positive neuromodulatory effects through auricular stimulation. Baseline conventional physiotherapy for both groups will include: thermotherapy (e.g., moist hot packs for 15 minutes), range of motion (ROM) exercises, stretching of involved muscles, and strengthening exercises.

non-invasive transcutaneous electrical nerve stimulation (TENS)

Group Type: EXPERIMENTAL

non-invasive transcutaneous electrical nerve stimulation (TENS)

Intervention Type: COMBINATION_PRODUCT

Group 2 will receive non-invasive transcutaneous electrical nerve stimulation (TENS) applied to the other areas to target other nerves stimulation (e.g., neck, upper trapezius, or occipital area). Surface electrodes will be placed paravertebrally, using a conventional TENS protocol: frequency of 20-25 Hz, pulse width of 200-300 µs, and intensity set to produce a strong but comfortable tingling sensation without muscle contraction. Each session will last 20-30 minutes, administered 5 days a week for 12 weeks. Baseline conventional physiotherapy for both groups will include: thermotherapy (e.g., moist hot packs for 15 minutes), range of motion (ROM) exercises, stretching of involved muscles, and strengthening exercises.

Interventions

non-invasive vagus nerve stimulation (nVNS)

Group 1 will receive non-invasive vagus nerve stimulation (nVNS) targeting the auricular branch of the vagus nerve (ABVN) using a TENS device with specialized ear clip electrodes. The electrodes will be placed on the cymba conchae or tragus region of the ear, where the ABVN is accessible. The stimulation parameters will be set to a frequency of 1 Hz (significantly reduced migraine headache), pulse width of 200-300 µs, and intensity adjusted to a strong but comfortable level without causing pain, applied for 15-30 minutes per session, 5 days a week for 12 weeks, based on protocols supported by evidence from studies such as Badran et al. (2018) and Yakunina et al. (2017), which demonstrated positive neuromodulatory effects through auricular stimulation. Baseline conventional physiotherapy for both groups will include: thermotherapy (e.g., moist hot packs for 15 minutes), range of motion (ROM) exercises, stretching of involved muscles, and strengthening exercises.

Intervention Type: COMBINATION_PRODUCT

non-invasive transcutaneous electrical nerve stimulation (TENS)

Group 2 will receive non-invasive transcutaneous electrical nerve stimulation (TENS) applied to the other areas to target other nerves stimulation (e.g., neck, upper trapezius, or occipital area). Surface electrodes will be placed paravertebrally, using a conventional TENS protocol: frequency of 20-25 Hz, pulse width of 200-300 µs, and intensity set to produce a strong but comfortable tingling sensation without muscle contraction. Each session will last 20-30 minutes, administered 5 days a week for 12 weeks. Baseline conventional physiotherapy for both groups will include: thermotherapy (e.g., moist hot packs for 15 minutes), range of motion (ROM) exercises, stretching of involved muscles, and strengthening exercises.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• People will be eligible for participation of 18-75 years of age.
• Participants are included with previous diagnosis of migraine with aura according to ICHD-3 beta criteria.
• Patients who had 15 headache days per month over the last 6 months will be included in this study.

Exclusion Criteria

• Participants with a history of secondary headaches,
• aneurysms, brain tumors, significant head trauma
• substance abuse, cardiovascular or cerebrovascular disease
• uncontrolled hypertension, psychiatric disorders,
• pregnancy, steroid use, botulinum toxin injections in the past 6 months, or certain other medical conditions were excluded.
• individuals with excessive use of pain medications, recent preventive treatments, or previous surgeries and procedures related to migraines will not be eligible.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall23/829

Identifier Type: -

Identifier Source: org_study_id