Vagal Nerve Stimulation and Pain Frequency, Intensity in Chronic Migraine

Riphah International University

Status: Enrolling

Conditions: Migraine

Treatments: Device: Vagal nerve stimulation; Device: Sham vagal nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06191016

REC01746 Rabia Nasir

Details and patient eligibility

About

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.

Full 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

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic migraine (headache for 15 or more days/month for more than three months), Migraine with/without aura

Exclusion criteria

• Mental illness, Photophobic individual, Presence of shunt and/or implant at the cranial region

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

nVNS Group

Experimental group

Description:

Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications

Treatment:

Device: Sham vagal nerve stimulation

Device: Vagal nerve stimulation

Sham Group

Active Comparator group

Description:

control will receive sham stimulation to vagal nerve along with prescribed medications.

Treatment:

Device: Sham vagal nerve stimulation

Device: Vagal nerve stimulation