Transcranial Direct Current Stimulation for Migraine Attack

Acute Migraine Clinical Trial

Official title:

Manho Kim, MD, PhD Professor, Neurology Seoul National University Hospital,

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358279
• Other study ID #: 2009-4615-A
• Status: Completed
• Phase: N/A
• First received: May 18, 2011
• Last updated: October 23, 2016
• Start date: January 2009
• Est. completion date: March 2011

Study information

• Verified date: October 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Procedure:
• transcranial direct current stimulation
A constant current of 2 mA intensity applied for 20 min over C3 or C4

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who experienced pain relief of one level or more		at 2h post-treatment	No