MigraineNCT03900611
Peripheral Electrical Stimulation for Migraine Prevention
A study testing peripheral electrical stimulation in people with Migraine, run by Taipei Veterans General Hospital, Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- peripheral electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Migraine:
- Diagnosed as migraine by International Classification of Headache Disorder (ICHD-III) criteria
- onset before 50 years old
- 20-65 yrs.
- 4 or more migraine days per month in average
- Healthy control:
- devoid of any systemic or neurological diseases
Who cannot join
- history of major systemic illness, including uncontrolled hypertension, diabetes, chronic renal insufficiency, autoimmune diseases or malignancies
- history of neurological disorders which might affect sensation such as previous stroke or peripheral neuropathy
- pregnancy or lactation
- epilepsy
- moderate depressed (BDI>20)
- using prophylactics for migraine
Show all 9Show fewer
- other remote electrical stimulation contraindications, such as open wound, sensory impairment, metal implant
- other transcranial magnetic stimulation contraindications, such as, high intracranial pressure, cochlear implant, cranial metal implant
- other magnetic resonance imaging contraindications, such as, pacemaker, stent, metal implant, claustrophobia
About this study
Official title: To Investigate the Effects of Peripheral Electrical Stimulation on Cortical Imagining, Electrophysiology and Clinical Profile in Patients With Migraine
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
- Being tested
- peripheral electrical stimulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral electrical stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Not described Receives: Device: peripheral electrical stimulation |
| Sham stimulation | Sham comparator | Not described Receives: Device: peripheral electrical stimulation |
| healthy control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in migraine or headache days of a month in average
change in migraine or headache days of a month in average
Measured: 2 months
responder rate
responder rate (50% pain reduction from baseline)
Measured: 2 months
Secondary outcomes (10)
change in moderate to severe headache days of a month in average
Measured: 2 months
acute headache medication use
Measured: 2 months
Beck Depression Inventory
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
Sensory threshold change after treatment
Using quantitative sensory testing (QST) to evaluate the sensory threshold before and after treatment
Measured: 2 months
EEG change after treatment (1) Linear analysis of EEG before and after treatment
power spectal density change of EEG before and after treatment
Measured: 2 months
EEG change after treatment (2) Nonlinear analysis of EEG before and after treatment
functional connectivity change of EEG before and after treatment
Measured: 2 months
fMRI change after treatment
functional connectivity change of fMRI before and after treatment
Measured: 2 months
MRI change after treatment
VBM changes of MRI before and after treatment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Feb 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900611
- Sponsor's protocol ID
- 2019-01-001C
- Status last verified
- Jan 2021
- First submitted
- 2 Apr 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effects of Peripheral Electrical Stimulation on Cortical Imagining, Electrophysiology and Clinical Profile in Patients With Migraine
- ClinicalTrials.gov ID
- NCT03900611
- Acronym / sponsor ID
- 2019-01-001C
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: peripheral electrical stimulation |
| Sham stimulation | Sham comparator | Device: peripheral electrical stimulation |
| healthy control | No intervention | – |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Migraine:
- Healthy control:
Key exclusion criteria (9 listed)
- history of major systemic illness, including uncontrolled hypertension, diabetes, chronic renal insufficiency, autoimmune diseases or malignancies
- history of neurological disorders which might affect sensation such as previous stroke or peripheral neuropathy
- pregnancy or lactation
- epilepsy
- moderate depressed (BDI>20)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral electrical stimulationThe 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. | Device | Active stimulation, Sham stimulation |
Primary outcome
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
responder rate
Time frame: 2 months
responder rate (50% pain reduction from baseline)
10 secondary outcomes
change in moderate to severe headache days of a month in average
Time frame: 2 months
acute headache medication use
Time frame: 2 months
Beck Depression Inventory
Time frame: 2 months
modified Migraine Disability Scale
Time frame: 2 months
Patient/Clinical Global Impression of Change
Time frame: 2 months
Sensory threshold change after treatment
Time frame: 2 months
EEG change after treatment (1) Linear analysis of EEG before and after treatment
Time frame: 2 months
EEG change after treatment (2) Nonlinear analysis of EEG before and after treatment
Time frame: 2 months
fMRI change after treatment
Time frame: 2 months
MRI change after treatment
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral electrical stimulation in people with Migraine, run by Taipei Veterans General Hospital, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in migraine or headache days of a month in average (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021; AzTrials last refreshed its copy on 30 Oct 2026.