Migraine
Conditions
Keywords
chronic migraine, vagal nerve stimulation, pain intensity and frequency
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
Interventions
DEVICEVagal nerve stimulation
Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications
control will receive sham stimulation to vagal nerve along with prescribed medications
Sponsors
Riphah International University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Contacts
Primary ContactRabia Nasir, DPT
Backup ContactMirza Obaid Baig, MSPT
Outcome results
None listed