Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura

This study has been completed.
Sponsor:
Information provided by:
Neuralieve
ClinicalTrials.gov Identifier:
NCT00449540
First received: March 18, 2007
Last updated: August 9, 2011
Last verified: July 2011
Results First Received: January 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Migraine With Aura
Interventions: Device: Active Transcranial Magnetic Stimulation (TMS) Device
Device: Sham TMS Device

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
267 participants enrolled in the 30 day Lead-In phase as described. 66 participants did not experience migraine in the 30 days allotted and therefore were not moved to the treatment phase. 201 participants were moved to the treatment phase

Reporting Groups
  Description
30 Day Lead in Phase some particpants did not experience migrain in the 30 days allotted and therefore were not moved to the treatment phase
Active TMS Active Transcranial Magnetic Stimulation Device
Sham TMS Device Device which does not deliver TMS pulse

Participant Flow for 2 periods

Period 1:   Pretreatment Phase
    30 Day Lead in Phase     Active TMS     Sham TMS Device  
STARTED     267     0     0  
COMPLETED     201     0     0  
NOT COMPLETED     66     0     0  
No migraine experienced                 66                 0                 0  

Period 2:   Treatment Phase
    30 Day Lead in Phase     Active TMS     Sham TMS Device  
STARTED     0     102     99  
COMPLETED     0     82     82  
NOT COMPLETED     0     20     17  
did not experience or treat migraine                 0                 20                 17  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active Transcranial Magnetic Stimulation (TMS) Device Active Transcranial Magnetic Stimulation Device Treatment
Sham TMS Device Simulated Sham treatment without TMS
Total Total of all reporting groups

Baseline Measures
    Active Transcranial Magnetic Stimulation (TMS) Device     Sham TMS Device     Total  
Number of Participants  
[units: participants]
  102     99     201  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     102     99     201  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.8  ± 11.2     40.1  ± 10.83     39.4  ± 11.0  
Gender  
[units: participants]
     
Female     80     78     158  
Male     22     21     43  
Region of Enrollment  
[units: participants]
     
United States     102     99     201  



  Outcome Measures
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1.  Primary:   Percentage of Participants Experiencing no Pain at Two Hours Post-treatment   [ Time Frame: Two hours ]

2.  Secondary:   Percentage of Participants Who Have Symptoms of Nausea   [ Time Frame: two hours post treatment ]

3.  Secondary:   Percentage of Participants Who Have Symptoms Phonophobia   [ Time Frame: 2 hours post treatment ]

4.  Secondary:   Percentage of Participants Who Have Photophobia   [ Time Frame: 2 hours post treatment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Cynthia Merrell
Organization: Neuralieve
phone: 408-245-6400
e-mail: cmerrell@neuralieve.com


No publications provided by Neuralieve

Publications automatically indexed to this study:

Responsible Party: Ting W. Lu / President and Chief Operating Officer, Neuralieve, Inc.
ClinicalTrials.gov Identifier: NCT00449540     History of Changes
Other Study ID Numbers: NL-2006-001
Study First Received: March 18, 2007
Results First Received: January 7, 2009
Last Updated: August 9, 2011
Health Authority: United States: Institutional Review Board