NCT01358279

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

May 18, 2011

Last Update Submit

October 23, 2016

Conditions

Acute Migraine

Outcome Measures

Primary Outcomes (1)

  • Number of participants who experienced pain relief of one level or more

    at 2h post-treatment

Study Arms (1)

migraine

EXPERIMENTAL
Procedure: transcranial direct current stimulation

Interventions

transcranial direct current stimulationPROCEDURE

A constant current of 2 mA intensity applied for 20 min over C3 or C4

migraine

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manho Kim, MD, PhD Professor, Neurology Seoul National University Hospital

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 23, 2011

Study Start

January 1, 2009

Primary Completion

October 1, 2009

Study Completion

March 1, 2011

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

KR(1)