NCT03900611

Peripheral Electrical Stimulation for Migraine Prevention

To Investigate the Effects of Peripheral Electrical Stimulation on Cortical Imagining, Electrophysiology and Clinical Profile in Patients With Migraine

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Migraine is a common and disabling disease that affects more than 10% of the population worldwide. The prevalence of migraine in Taiwan is around 9.1%. The migraineurs missed 2 workdays due to migraine per year, that is 3.7 million estimated missed workdays in total and an estimated cost of 4.6 billion New Taiwan dollars. In addition, some migraineurs have poor response to the medications or suffer from adverse effects, and may further develop medication-overuse headache. Therefore, in recent years, efforts have been made to develop non-medication treatments, and the number of studies using neuromodulation as an intervention has increased dramatically. Among them, peripheral electrical stimulation has long been a routine treatment for pain in the clinic, and research has also shown its good evidence. In addition, recent studies have shown that peripheral electrical stimulation can also alter the cortical activities. Compared with the proximal brain stimulation, the remote electrical stimulation is safer, more convenient, less expensive and suitable for home use. To date, only one research had focused on the immediate anesthetic effect of remote electrical stimulation whereas the research for migraine prevention is still absent. Therefore, we expect to utilize a more remote electrical stimulation than trigeminal nerve electrical stimulation, which is the commonly used research method nowadays, as an interventional model. In three years, we will recruit 80 migraineurs along with 40 healthy controls and investigate the effects of 8-week home-based remote electrical stimulation on the prevention of migraine and the mechanisms using brain imaging, electrophysiological and biochemical examinations. We also aim to identify the predictors of the responders to remote electrical stimulation. If the effects of remote electrical stimulation are confirmed, as a non-drug neuromodulation management with features of non-invasive, low adverse effects and high accessibility, it will greatly lower the cost of social health care and better improve the quality of life and clinical status of the migraineurs.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	peripheral electrical stimulation	The subjects will undergo 8-week home-based peripheral electrical simulation on the median nerve. The peripheral electrical simulation will be performed once a day for 30 minutes. The stimulation will be active or sham depend on the group assignment.

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2019-04-03
• Last updated: 2021-01-29