Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449540
Status:
COMPLETED
Last Update Posted:
2011-08-15
First Post:
2007-03-18
Brief Title:
Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
Sponsor:
Neuralieve
Organization:
Neuralieve
Study Overview
Official Title:
Phase III Randomized Double-Blind Parallel Group Sham-Controlled Study Evaluating the Efficacy and Safety of Non-invasive Non-repetitive Transcranial Magnetic Stimulation TMS for the Acute Preemptive Treatment of the Aura Phase of Migraine Headache
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Assess safety and efficacy of Transcranial Magnetic Stimulation TMS for the treatment of migraine with aura
The hypothesis is that TMS treatments delivered to the occipital cortex of the brain can stop or interrupt the spreading cortical brain activity that causes or contributes to the migraine headache Two TMS treatments at an intensity of 1 Tesla for 500 microseconds approximately 30 seconds apart may stop the aura and prevent the subsequent headache
The hypothesis is that TMS treatments delivered to the occipital cortex of the brain can stop or interrupt the spreading cortical brain activity that causes or contributes to the migraine headache Two TMS treatments at an intensity of 1 Tesla for 500 microseconds approximately 30 seconds apart may stop the aura and prevent the subsequent headache
Detailed Description:
In the Lead-in Phase participants will use a Personal Digital Assistant PDA to keep an electronic diary of their migraine episodes During a migraine episode as well as the time in between headaches the PDA prompts the participant to answer questions Each evening the participant will place the PDA into an electronic telephone cradle and the information will be transmitted electronically from the PDA to the data management team to assess the frequency of migraine episodes and participant proficiency with the PDA During this one month period the participant must experience at least one migraine with aura episode to enter the Treatment Phase
After one month the participant will return to the clinic with their PDA and will enter the Treatment Phase to be randomized to either the TMS only group or the Sham stimulation only group Participant will enter information into the PDA for three migraine auras treated or three months which ever comes first
After one month the participant will return to the clinic with their PDA and will enter the Treatment Phase to be randomized to either the TMS only group or the Sham stimulation only group Participant will enter information into the PDA for three migraine auras treated or three months which ever comes first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None