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Transcranial Direct Current Stimulation for Migraine Attack

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01358279
First received: May 18, 2011
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Acute Migraine
 Procedure: transcranial direct current stimulation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Migraine
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Number of participants who experienced pain relief of one level or more [ Time Frame: at 2h post-treatment ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2009
Study Completion Date: March 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: migraine Procedure: transcranial direct current stimulation
A constant current of 2 mA intensity applied for 20 min over C3 or C4

  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358279

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: MH Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01358279     History of Changes
Other Study ID Numbers: 2009-4615-A
Study First Received: May 18, 2011
Last Updated: June 15, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013