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

S

Superior University

Status

Active, not recruiting

Conditions

Migraine

Treatments

Combination Product: non-invasive transcutaneous electrical nerve stimulation (TENS)
Combination Product: non-invasive vagus nerve stimulation (nVNS)

Study type

Interventional

Funder types

Other

Identifiers

NCT07055776
MSRSW/Batch-Fall23/829

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

non-invasive vagus nerve stimulation (nVNS)
Experimental group
Treatment:
Combination Product: non-invasive vagus nerve stimulation (nVNS)
non-invasive transcutaneous electrical nerve stimulation (TENS)
Experimental group
Treatment:
Combination Product: non-invasive transcutaneous electrical nerve stimulation (TENS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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