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Peripheral Electrical Stimulation for Migraine Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03900611
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 10, 2019
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Migraine Device: peripheral electrical stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: To Investigate the Effects of Peripheral Electrical Stimulation on Cortical Imagining, Electrophysiology and Clinical Profile in Patients With Migraine
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Active stimulation 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.

Sham Comparator: Sham stimulation 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.

No Intervention: healthy control

Primary Outcome Measures :
  1. change in migraine or headache days of a month in average [ Time Frame: 2 months ]
    change in migraine or headache days of a month in average

  2. responder rate [ Time Frame: 2 months ]
    responder rate (50% pain reduction from baseline)

Secondary Outcome Measures :
  1. change in moderate to severe headache days of a month in average [ Time Frame: 2 months ]
  2. acute headache medication use [ Time Frame: 2 months ]
  3. Beck Depression Inventory [ Time Frame: 2 months ]
  4. modified Migraine Disability Scale [ Time Frame: 2 months ]
    This modified Migraine Disability Scale assesses the migraine related disability in the past 1 month. The total score will be compared and the lower score stands for better outcome.

  5. Patient/Clinical Global Impression of Change [ Time Frame: 2 months ]
    Patient/Clinical Global Impression of Change (PGIC/CGIC) are 7-point scales to assess the improvement by patients themselves and by their clinicians.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Responsible Party: Taipei Veterans General Hospital, Taiwan Identifier: NCT03900611    
Other Study ID Numbers: 2019-01-001C
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases