Efficacy of rTMS in the Treatment of Patients With Migraine | NCT00316979

Studies
Efficacy of rTMS in the Treatment of Patients With Migraine

NCT00316979

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Unknown status

Last Update Posted

Jun 8, 2010Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Migraine

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Countries

Taiwan

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 20, 2006

First Submission Date that Met QC Criteria

Apr 20, 2006

First Posted Date

Apr 21, 2006Estimated

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

Jun 6, 2010

Last Update Posted Date

Jun 8, 2010Estimated

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Migraine is a condition thought to be related to cortical hyperexcitability. Repetitive transcranial magnetic stimulation (rTMS) can modulate the cortical excitability by means of long-term potentiation or long-term depression. This study will will test the safety and efficacy of rTMS in the treatment of patients with Migraine.

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

80Estimated

Name	Type	Description	Arm Group Labels	Other Names
Repetitive Transcranial Magnetic Stimulation (rTMS)	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in days of migraine attack per month

Secondary Outcomes

Measure	Description	Time Frame
The reduction in dosage of acute abortive medication
The reduction of headache index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of 18-65 years
Diagnosed as migraine (with or without aura)
More than 4 attacks per month for at least 3 months prior to study
No preventive medication used
Must be able to sign permit

Exclusion Criteria:

History of seizure or family history of seizures
Women in pregnancy or breast-feeding
Patient with medication overuse
Patient with other medical, psychologic, or surgical illness
Patient under preventive medications
Prior rTMS examination one month within

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shuu-Jiun Wang, MD	Contact	+886-2-28712121	2425	sjwang@vghtpe.gov.tw
Kuan-Lin Lai, MD	Contact	+886-2-28712121	3185	kllai@vghtpe.gov.tw

Overall Officials

Name	Affiliation	Role
Shuu-Jiun Wang, MD	Headache Center, Taipei Veterans General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Headache Center, Teipei Veterans General Hospital	Recruiting	Taipei		112	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15546593	Background	Brighina F, Piazza A, Vitello G, Aloisio A, Palermo A, Daniele O, Fierro B. rTMS of the prefrontal cortex in the treatment of chronic migraine: a pilot study. J Neurol Sci. 2004 Dec 15;227(1):67-71. doi: 10.1016/j.jns.2004.08.008.
12690048	Background	Lorenz J, Minoshima S, Casey KL. Keeping pain out of mind: the role of the dorsolateral prefrontal cortex in pain modulation. Brain. 2003 May;126(Pt 5):1079-91. doi: 10.1093/brain/awg102.

Type	Date	Date Unknown
Release	Jun 14, 2011
Reset	Jul 8, 2011
Release	Jul 12, 2011
Reset	Aug 4, 2011
Release	Apr 19, 2012
Reset	May 23, 2012

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 14, 2011			Jul 8, 2011
Jul 12, 2011

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics