Transcranial Direct Current Stimulation for Migraine Attack | NCT01358279

Studies
Transcranial Direct Current Stimulation for Migraine Attack

NCT01358279

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Oct 25, 2016Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Acute Migraine

Interventions

transcranial direct current stimulation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Oct 2009Actual

Completion Date

Mar 2011Actual

First Submitted Date

May 18, 2011

First Submission Date that Met QC Criteria

May 20, 2011

First Posted Date

May 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2016

Last Update Posted Date

Oct 25, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
migraine	Experimental		Procedure: transcranial direct current stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transcranial direct current stimulation	Procedure	A constant current of 2 mA intensity applied for 20 min over C3 or C4	migraine

Measure	Description	Time Frame
Number of participants who experienced pain relief of one level or more		at 2h post-treatment

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D065908	Transcranial Direct Current Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies

Browse Leaves

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Browse Branches

Not provided