We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00449540
First Posted: March 20, 2007
Last Update Posted: August 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Neuralieve
Results First Submitted: January 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Migraine With Aura
Interventions: Device: Active Transcranial Magnetic Stimulation (TMS) Device
Device: Sham TMS Device

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Submitted: March 18, 2007
First Posted: March 20, 2007
Results First Submitted: January 7, 2009
Results First Posted: August 10, 2011
Last Update Posted: August 15, 2011



To Top