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

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ClinicalTrials.gov Identifier: NCT00449540
Recruitment Status : Completed
First Posted : March 20, 2007
Results First Posted : August 10, 2011
Last Update Posted : August 15, 2011
Sponsor:
Information provided by:
Neuralieve

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
Enrollment 201
Recruitment Details  
Pre-assignment Details 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
Arm/Group Title 30 Day Lead in Phase Active TMS Sham TMS Device
Hide Arm/Group Description some particpants did not experience migrain in the 30 days allotted and therefore were not moved to the treatment phase Active Transcranial Magnetic Stimulation Device Device which does not deliver TMS pulse
Period Title: Pretreatment Phase
Started 267 0 0
Completed 201 0 0
Not Completed 66 0 0
Reason Not Completed
No migraine experienced             66             0             0
Period Title: Treatment Phase
Started 0 102 99
Completed 0 82 82
Not Completed 0 20 17
Reason Not Completed
did not experience or treat migraine             0             20             17
Arm/Group Title Active Transcranial Magnetic Stimulation (TMS) Device Sham TMS Device Total
Hide Arm/Group Description Active Transcranial Magnetic Stimulation Device Treatment Simulated Sham treatment without TMS Total of all reporting groups
Overall Number of Baseline Participants 102 99 201
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 99 participants 201 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
102
 100.0%
99
 100.0%
201
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 99 participants 201 participants
38.8  (11.2) 40.1  (10.83) 39.4  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 99 participants 201 participants
Female
80
  78.4%
78
  78.8%
158
  78.6%
Male
22
  21.6%
21
  21.2%
43
  21.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 102 participants 99 participants 201 participants
102 99 201
1.Primary Outcome
Title Percentage of Participants Experiencing no Pain at Two Hours Post-treatment
Hide Description Number of participants experiencing no pain at two hours post-treatment divided by total number of participants treated. For each treated aura episode during the migraine treatment phase, the subjects rated the pain intensity of their headache as none, mild, moderate or severe at baseline (before application of the study device) at 30 minutes, and at 1, 2, 24, and 48 hours posttreatement.
Time Frame Two hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full-analysis set: intention to treat population (201) adjusted for those participants who did not administer treatment during the study period
Arm/Group Title Active Transcranial Magnetic Stimulation (TMS) Device Sham TMS Device
Hide Arm/Group Description:
Active Transcranial Magnetic Stimulation Device Treatment
Simulated Sham treatment without TMS
Overall Number of Participants Analyzed 82 82
Measure Type: Number
Unit of Measure: percentage of participants
39 22
2.Secondary Outcome
Title Percentage of Participants Who Have Symptoms of Nausea
Hide Description Percentage of participants who have symptoms of nausea two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
Time Frame two hours post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Transcranial Magnetic Stimulation (TMS) Device Sham TMS Device
Hide Arm/Group Description:
Active Transcranial Magnetic Stimulation Device Treatment
Simulated Sham treatment without TMS
Overall Number of Participants Analyzed 82 82
Measure Type: Number
Unit of Measure: percentage of participants
38 40
3.Secondary Outcome
Title Percentage of Participants Who Have Symptoms Phonophobia
Hide Description Percentage of participants who have symptoms of phonophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
Time Frame 2 hours post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Transcranial Magnetic Stimulation (TMS) Device Sham TMS Device
Hide Arm/Group Description:
Active Transcranial Magnetic Stimulation Device Treatment
Simulated Sham treatment without TMS
Overall Number of Participants Analyzed 82 82
Measure Type: Number
Unit of Measure: Percentage of Participants
57 63
4.Secondary Outcome
Title Percentage of Participants Who Have Photophobia
Hide Description Percentage of participants who have symptoms of photophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
Time Frame 2 hours post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Transcranial Magnetic Stimulation (TMS) Device Sham TMS Device
Hide Arm/Group Description:
Active Transcranial Magnetic Stimulation Device Treatment
Simulated Sham treatment without TMS
Overall Number of Participants Analyzed 82 82
Measure Type: Number
Unit of Measure: Percentage of participants
70 78
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active TMS Device - Treatment Related Sham TMS Device - Treatment Related Active TMS - Not Treatment Related Sham TMS Device - Not Treatment Related
Hide Arm/Group Description Active Transcranial Magnetic Stimulation Device Treatment - Treatment related Simulated Sham treatment without TMS Active Transcranial Magnetic Stimulation Device Treatment - Not treatment related Sham TMS Device - events that are not treatment related
All-Cause Mortality
Active TMS Device - Treatment Related Sham TMS Device - Treatment Related Active TMS - Not Treatment Related Sham TMS Device - Not Treatment Related
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active TMS Device - Treatment Related Sham TMS Device - Treatment Related Active TMS - Not Treatment Related Sham TMS Device - Not Treatment Related
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/102 (0.00%)      0/99 (0.00%)      1/102 (0.98%)      0/99 (0.00%)    
Eye disorders         
optic neuritis * [1]  0/102 (0.00%)  0 0/99 (0.00%)  0 1/102 (0.98%)  1 0/99 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
One serious adverse event,optic neuritis,was reported in one subject who was randomized to the TMS group. The optic neuritis for Subject was not considered by the investigator and medical monitor to be related to the study treatment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active TMS Device - Treatment Related Sham TMS Device - Treatment Related Active TMS - Not Treatment Related Sham TMS Device - Not Treatment Related
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/102 (6.86%)      2/99 (2.02%)      12/102 (11.76%)      8/99 (8.08%)    
General disorders         
Application site pain  1/102 (0.98%)  1 0/99 (0.00%)  0 0/102 (0.00%)  0 0/99 (0.00%)  0
Gastric ulcer  0/102 (0.00%)  0 0/99 (0.00%)  0 1/102 (0.98%)  1 0/99 (0.00%)  0
Nausea  1/102 (0.98%)  1 1/99 (1.01%)  1 0/102 (0.00%)  0 0/99 (0.00%)  0
Rash  0/102 (0.00%)  0 0/99 (0.00%)  0 1/102 (0.98%)  1 0/99 (0.00%)  0
Vomiting  1/102 (0.98%)  1 0/99 (0.00%)  0 0/102 (0.00%)  0 0/99 (0.00%)  0
Tempromandibular joint syndrome  0/102 (0.00%)  0 0/99 (0.00%)  0 1/102 (0.98%)  1 0/99 (0.00%)  0
Road traffic Accident  0/102 (0.00%)  0 0/99 (0.00%)  0 0/102 (0.00%)  0 1/99 (1.01%)  1
Sleep disorder  0/102 (0.00%)  0 0/99 (0.00%)  0 0/102 (0.00%)  0 1/99 (1.01%)  1
Infections and infestations         
Tooth infection  0/102 (0.00%)  0 0/99 (0.00%)  0 0/102 (0.00%)  0 1/99 (1.01%)  1
Nervous system disorders         
Headache  1/102 (0.98%)  1 0/99 (0.00%)  0 1/102 (0.98%)  1 1/99 (1.01%)  1
Migraine  1/102 (0.98%)  1 0/99 (0.00%)  0 1/102 (0.98%)  1 0/99 (0.00%)  0
aphasia  0/102 (0.00%)  0 0/99 (0.00%)  0 1/102 (0.98%)  1 0/99 (0.00%)  0
Dizzines  1/102 (0.98%)  1 0/99 (0.00%)  0 0/102 (0.00%)  0 0/99 (0.00%)  0
Optic neuritis  0/102 (0.00%)  0 0/99 (0.00%)  0 1/102 (0.98%)  1 0/99 (0.00%)  0
Palpitations  0/102 (0.00%)  0 0/99 (0.00%)  0 1/102 (0.98%)  1 0/99 (0.00%)  0
Vertigo  1/102 (0.98%)  1 0/99 (0.00%)  0 0/102 (0.00%)  0 0/99 (0.00%)  0
Concussion  0/102 (0.00%)  0 0/99 (0.00%)  0 0/102 (0.00%)  0 1/99 (1.01%)  1
Neck Pain  0/102 (0.00%)  0 0/99 (0.00%)  0 0/102 (0.00%)  0 1/99 (1.01%)  1
Paresthesia  0/102 (0.00%)  0 1/99 (1.01%)  1 0/102 (0.00%)  0 1/99 (1.01%)  1
Respiratory, thoracic and mediastinal disorders         
Sinusitis  0/102 (0.00%)  0 0/99 (0.00%)  0 2/102 (1.96%)  2 1/99 (1.01%)  1
Bronchitis  0/102 (0.00%)  0 0/99 (0.00%)  0 1/102 (0.98%)  1 0/99 (0.00%)  0
Influenza  0/102 (0.00%)  0 0/99 (0.00%)  0 1/102 (0.98%)  1 0/99 (0.00%)  0
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.
Results Point of Contact
Name/Title: Cynthia Merrell
Organization: Neuralieve
Phone: 408-245-6400
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