NCT06191016

Vagal Nerve Stimulation and Pain Frequency, Intensity in Chronic Migraine

Effects of Vagal Nerve Stimulation on Pain Frequency and Intensity in Chronic Migraine

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Riphah International University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to address the need for effective and well-tolerated interventions in preventing chronic migraine attacks. Chronic migraines significantly impact the quality of life for individuals suffering from them, often leading to substantial discomfort and impairment. By evaluating the feasibility, safety, and acceptance of noninvasive vagus nerve stimulation (nVNS), researchers aim to determine if this approach can offer a viable solution for alleviating the frequency and severity of chronic migraine episodes. If successful, this study could potentially introduce a promising new treatment option that enhances the well-being and daily functioning of those affected by chronic migraines.

Detailed description

Neuromodulation is a growing field in headache management. Technology ranges from invasive deep brain stimulation (DBS) of the posterior hypothalamus, to minimally invasive percutaneous electrode implantation for occipital nerve stimulation, and noninvasive transcranial magnetic stimulation and transcranial direct current stimulation. Neurostimulation can be particularly useful to those who failed triptans or other prophylactic treatments. The European Headache Federation positioned that a neurostimulation device should only be used in medically intractable headache patient who has been evaluated at a tertiary headache center. Vagus nerve stimulation (VNS), which has demonstrated its antinociceptive potential, may also provide a relief of pain associated with headache

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Vagal nerve stimulation	Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications
DEVICE	Sham vagal nerve stimulation	control will receive sham stimulation to vagal nerve along with prescribed medications

Timeline

• Start date: 2023-12-26
• Primary completion: 2024-09-30
• Completion: 2024-10-31
• First posted: 2024-01-05
• Last updated: 2024-01-19

Locations

1 site across 1 country: Pakistan