Acute MigraineNCT01358279
Transcranial Direct Current Stimulation for Migraine Attack
A study testing transcranial direct current stimulation in people with Acute Migraine, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is conducted to investigate the therapeutic efficacy and safety of transcranial direct current stimulation (tDCS) over the primary motor cortex of patients with acute migraine attack. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Acute Migraine
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Mar 2011
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 17-70 years
- Migraine
- With or without aura
- The first attack of migraine was earlier than 50 years of age
- One to 8 moderate to severe migraine attacks per month in the 2 months preceding the screening
- Willing and able to give written informed consent
- Able to read, comprehend and complete the diary form
Who cannot join
- Not able to distinguish between migraine and non-migraine headache
- Combined headache, including the tension type headache and medication overuse headache
- Pregnant, actively trying to become pregnant or breast-feeding women
- Uncontrolled and significant medical illness
- Vertebrobasilar or hemiplegic migraine according to the International Headache Society diagnostic criteria
- Having intracranial metal implants or a cardiac pacemaker
Show all 10Show fewer
- A history of epilepsy or other organic brain disorders
- A history of psychological diseases
- Having changed medications for migraine within 1 month before giving us informed consent
- Drug abuser or alcoholics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manho Kim, MD, PhD Professor, Neurology Seoul National University Hospital,
This study is conducted to investigate the therapeutic efficacy and safety of transcranial direct current stimulation (tDCS) over the primary motor cortex of patients with acute migraine attack.
- Conditions
- Acute Migraine
- Being tested
- transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationProcedure or surgery
A constant current of 2 mA intensity applied for 20 min over C3 or C4
| Study group | Role | What they receive |
|---|---|---|
| migraine | Experimental | Not described Receives: Procedure: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experienced pain relief of one level or more
Measured: at 2h post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MigraineStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manho Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358279
- Sponsor's protocol ID
- 2009-4615-A
- Status last verified
- Oct 2016
- First submitted
- 18 May 2011
- Last updated
- 25 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manho Kim, MD, PhD Professor, Neurology Seoul National University Hospital,
- ClinicalTrials.gov ID
- NCT01358279
- Acronym / sponsor ID
- 2009-4615-A
- Conditions
- Acute Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 May 2011 (estimated)
- 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.
This study is conducted to investigate the therapeutic efficacy and safety of transcranial direct current stimulation (tDCS) over the primary motor cortex of patients with acute migraine attack.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| migraine | Experimental | Procedure: transcranial direct current stimulation |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 17-70 years
- Migraine
- Willing and able to give written informed consent
- Able to read, comprehend and complete the diary form
Key exclusion criteria (10 listed)
- Not able to distinguish between migraine and non-migraine headache
- Combined headache, including the tension type headache and medication overuse headache
- Pregnant, actively trying to become pregnant or breast-feeding women
- Uncontrolled and significant medical illness
- Vertebrobasilar or hemiplegic migraine according to the International Headache Society diagnostic criteria
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 |
|---|---|---|
| transcranial direct current stimulationA constant current of 2 mA intensity applied for 20 min over C3 or C4 | Procedure or surgery | migraine |
Primary outcome
Number of participants who experienced pain relief of one level or more
Time frame: at 2h post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Acute Migraine, run by Seoul National University Hospital at 1 site in South Korea.
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 10 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: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants who experienced pain relief of one level or more (time frame: at 2h post-treatment). 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 25 Oct 2016; AzTrials last refreshed its copy on 28 Oct 2026.