Peripheral Electrical Stimulation for Migraine Prevention

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03900611
• Other study ID #: 2019-01-001C
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in migraine or headache days of a month in average	change in migraine or headache days of a month in average	2 months
Primary	responder rate	responder rate (50% pain reduction from baseline)	2 months
Secondary	change in moderate to severe headache days of a month in average		2 months
Secondary	acute headache medication use		2 months
Secondary	Beck Depression Inventory		2 months
Secondary	modified Migraine Disability Scale	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.	2 months
Secondary	Patient/Clinical Global Impression of Change	Patient/Clinical Global Impression of Change (PGIC/CGIC) are 7-point scales to assess the improvement by patients themselves and by their clinicians.	2 months
Secondary	Sensory threshold change after treatment	Using quantitative sensory testing (QST) to evaluate the sensory threshold before and after treatment	2 months
Secondary	EEG change after treatment (1) Linear analysis of EEG before and after treatment	power spectal density change of EEG before and after treatment	2 months
Secondary	EEG change after treatment (2) Nonlinear analysis of EEG before and after treatment	functional connectivity change of EEG before and after treatment	2 months
Secondary	fMRI change after treatment	functional connectivity change of fMRI before and after treatment	2 months
Secondary	MRI change after treatment	VBM changes of MRI before and after treatment	2 months