Efficacy of rTMS in the Treatment of Patients With Migraine
Primary Purpose
Migraine
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring migraine, transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, rTMS
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
Sites / Locations
- Headache Center, Teipei Veterans General HospitalRecruiting
Outcomes
Primary Outcome Measures
Reduction in days of migraine attack per month
Secondary Outcome Measures
The reduction in dosage of acute abortive medication
The reduction of headache index
Full Information
NCT ID
NCT00316979
First Posted
April 20, 2006
Last Updated
June 6, 2010
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00316979
Brief Title
Efficacy of rTMS in the Treatment of Patients With Migraine
Official Title
Therapeutic Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Migraine Using Somatosensory Evoked High-Frequency Oscillations as a Parameter: A 3-year Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, rTMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Primary Outcome Measure Information:
Title
Reduction in days of migraine attack per month
Secondary Outcome Measure Information:
Title
The reduction in dosage of acute abortive medication
Title
The reduction of headache index
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuu-Jiun Wang, MD
Phone
+886-2-28712121
Ext
2425
Email
sjwang@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Kuan-Lin Lai, MD
Phone
+886-2-28712121
Ext
3185
Email
kllai@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuu-Jiun Wang, MD
Organizational Affiliation
Headache Center, Taipei Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Headache Center, Teipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuu-Jiun Wang, MD
Phone
+886-2-28712121
Ext
2425
Email
sjwang@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Jong-Ling Fuh, MD
Phone
+886-2-28712121
Ext
3256
Email
jlfuh@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Shuu-Jiun Wang, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15546593
Citation
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.
Results Reference
background
PubMed Identifier
12690048
Citation
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.
Results Reference
background
Learn more about this trial
Efficacy of rTMS in the Treatment of Patients With Migraine
We'll reach out to this number within 24 hrs