Effects of Vagal Nerve Stimulation on Pain Frequency and Intensity in Chronic Migraine
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Migraine
- Sponsor
- Riphah International University
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Structured Headache Diary Data for frequency of migraine
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Structured Headache Diary Data for frequency of migraine
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Migraine-Specific Quality of Life Survey (MSQ 2.1) for quality of life(Week 4)