Vagal Nerve Stimulation and Pain Frequency, Intensity in Chronic Migraine

Not Applicable

Recruiting

Interventions: Device: Vagal nerve stimulation
Device: Sham vagal nerve stimulation

Brief 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
nVNS Group	Vagal nerve stimulation	Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications
Sham Group	Sham vagal nerve stimulation	control will receive sham stimulation to vagal nerve along with prescribed medications.
nVNS Group	Sham vagal nerve stimulation	Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications
Sham Group	Vagal nerve stimulation	control will receive sham stimulation to vagal nerve along with prescribed medications.

Primary Outcome Measures

Name	Time	Method
Structured Headache Diary Data for frequency of migraine	Week 4	Diaries and calendars make possible to record prospectively the characteristics of every attack and this may reduce the recall bias and increase the accuracy of the description.
Multidimensional Pain Inventory (MPI) for migraine impact	Week 4	The MPI was administered pretreatment. It is a 61-item self-administered questionnaire composed of 12 empirically derived scales designed to measure a patients' experiences of pain, their spouses responses to their pain, and their general activity levels
Numeric Pain Scale (NPS) for intensity of migraine	Week 4	NPS was implemented in clinical practice due to its rapidity both verbally and in writing. Due to its convenience, it is common for hospitals to measure pain using the 0 to 10 NPS scale

Secondary Outcome Measures

Name	Time	Method
Migraine-Specific Quality of Life Survey (MSQ 2.1) for quality of life	Week 4	The MSQOL is a measure to assess the effects of migraine over the longer term on patient well-being over a nonspecified time period, and the MQoLQ is designed to measure the short-term impact of migraine over a 24-hour period following the start of therapy for migraine.

Locations (1): Pakistan Railway General Hospital
🇵🇰
Rawalpindi, Punjab, Pakistan

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