Clinical trial NCT03900611: Peripheral Electrical Stimulation for Migraine Prevention
Official title: To Investigate the Effects of Peripheral Electrical Stimulation on Cortical Imagining, Electrophysiology and Clinical Profile in Patients With Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-04-03
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Migraine:

  1. Diagnosed as migraine by International Classification of Headache Disorder (ICHD-III) criteria
  2. onset before 50 years old
  3. 20-65 yrs.
  4. 4 or more migraine days per month in average
* Healthy control:

  1. devoid of any systemic or neurological diseases

Exclusion Criteria:

1. history of major systemic illness, including uncontrolled hypertension, diabetes, chronic renal insufficiency, autoimmune diseases or malignancies
2. history of neurological disorders which might affect sensation such as previous stroke or peripheral neuropathy
3. pregnancy or lactation
4. epilepsy
5. moderate depressed (BDI\>20)
6. using prophylactics for migraine
7. other remote electrical stimulation contraindications, such as open wound, sensory impairment, metal implant
8. other transcranial magnetic stimulation contraindications, such as, high intracranial pressure, cochlear implant, cranial metal implant
9. other magnetic resonance imaging contraindications, such as, pacemaker, stent, metal implant, claustrophobia

Primary outcomes:
measure: change in migraine or headache days of a month in average
timeFrame: 2 months
measure: responder rate
timeFrame: 2 months
Secondary outcomes:
measure: change in moderate to severe headache days of a month in average
timeFrame: 2 months
measure: acute headache medication use
timeFrame: 2 months
measure: Beck Depression Inventory
timeFrame: 2 months
measure: modified Migraine Disability Scale
timeFrame: 2 months
measure: Patient/Clinical Global Impression of Change
timeFrame: 2 months
measure: Sensory threshold change after treatment
timeFrame: 2 months
measure: EEG change after treatment (1) Linear analysis of EEG before and after treatment
timeFrame: 2 months
measure: EEG change after treatment (2) Nonlinear analysis of EEG before and after treatment
timeFrame: 2 months
measure: fMRI change after treatment
timeFrame: 2 months
measure: MRI change after treatment
timeFrame: 2 months
Other outcomes:
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