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

Primary Purpose

Migraine With Aura

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Active Transcranial Magnetic Stimulation (TMS) Device
Sham TMS Device
Sponsored by
Neuralieve
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine With Aura focused on measuring Migraine with aura, aura, TMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 - 65 years
  • Will comply with requirements of the protocol

  • Have a consistent history of migraine with visual aura of at least one year

    •>30% of episodes have a visual aura preceding headaches

  • Approximately 90% of the time have moderate or severe headaches following their aura
  • Fulfills the International Classification of Headache Disorders, 2nd Edition(ICHD-II) criteria(for migraine headache with aura after administration of a clinical interview by study personnel
  • Has a history of 1-8 migraine headache episodes with aura per month
  • Can differentiate a migraine headache from other types of headaches
  • Participant is post-menopausal, sterilized, not breastfeeding, her pregnancy test is negative

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Routinely experiences any other type of headache that would confound discrimination from migraine headache with aura
  • Have migraine with prolonged aura > 60 minutes
  • Have headaches due to other underlying pathology
  • Have headaches related to head or neck trauma
  • Overuse headache medications:
  • Has an intracranial metallic or Transcranial Magnetic Stimulation (TMS) implant or other metallic implants
  • Has cardiac pacemaker or any other implanted electronic device
  • Has any known history of alcohol abuse, drug dependency, or significant psychiatric illness in the previous 12 months
  • Having any medical condition, including but not limited to: clinically significant renal or hepatic disease; uncontrolled hypertension; clinically significant coronary vascular disease not stable for the past 6 months; personal or family history of seizures or taking medications for seizures or drugs that may lower seizure threshold, cerebral vascular ischemia; infarct; hemorrhage, or other central nervous system disease (e.g., multiple sclerosis, amyotrophic lateral sclerosis); unstable metabolic disease, hypoglycemia or diabetes; malignancy within the past 5 years excluding cutaneous basal cell carcinoma; tuberculosis
  • Has participated in any other investigational study within the previous 30 days.
  • Cannot place the device within 1 cm of the scalp.

Sites / Locations

  • San Francisco Headache Clinic
  • Mile High Research Center
  • Diamond Headache Clinic, LTD
  • Michigan Head Pain & Neurological Institute
  • Westside Family Medical Center
  • Clinvest, Inc.
  • Mercy Health Research
  • Kirchner Headache Clinic
  • Montefiore Headache Center
  • The Ohio State University
  • Jefferson Headache Center
  • Nashville Neuroscience Group
  • The Innovative Clinical Research Center
  • Swedish Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Transcranial Magnetic Stimulation (TMS) Device

Sham TMS Device

Arm Description

Both arms of participants receive identical looking devices and were instructed use the same treatment protocol. Participants in each group were instructed to treat with the device within one hour of onset of migraine aura.

Both arms of participants receive identical looking devices and were instructed use the same treatment protocol. Participants in each group were instructed to treat with the device within one hour of onset of migraine aura.

Outcomes

Primary Outcome Measures

Percentage of Participants Experiencing no Pain at Two Hours Post-treatment
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.

Secondary Outcome Measures

Percentage of Participants Who Have Symptoms of Nausea
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.
Percentage of Participants Who Have Symptoms Phonophobia
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.
Percentage of Participants Who Have Photophobia
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.

Full Information

First Posted
March 18, 2007
Last Updated
August 9, 2011
Sponsor
Neuralieve
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1. Study Identification

Unique Protocol Identification Number
NCT00449540
Brief Title
Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neuralieve

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura
Keywords
Migraine with aura, aura, TMS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Transcranial Magnetic Stimulation (TMS) Device
Arm Type
Active Comparator
Arm Description
Both arms of participants receive identical looking devices and were instructed use the same treatment protocol. Participants in each group were instructed to treat with the device within one hour of onset of migraine aura.
Arm Title
Sham TMS Device
Arm Type
Sham Comparator
Arm Description
Both arms of participants receive identical looking devices and were instructed use the same treatment protocol. Participants in each group were instructed to treat with the device within one hour of onset of migraine aura.
Intervention Type
Device
Intervention Name(s)
Active Transcranial Magnetic Stimulation (TMS) Device
Intervention Description
Transcranial Magnetic Stimulation Device treatment
Intervention Type
Device
Intervention Name(s)
Sham TMS Device
Intervention Description
Simulated Sham treatment without TMS delivery
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing no Pain at Two Hours Post-treatment
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
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Have Symptoms of Nausea
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
Title
Percentage of Participants Who Have Symptoms Phonophobia
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
Title
Percentage of Participants Who Have Photophobia
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

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: 18 - 65 years Will comply with requirements of the protocol Have a consistent history of migraine with visual aura of at least one year •>30% of episodes have a visual aura preceding headaches Approximately 90% of the time have moderate or severe headaches following their aura Fulfills the International Classification of Headache Disorders, 2nd Edition(ICHD-II) criteria(for migraine headache with aura after administration of a clinical interview by study personnel Has a history of 1-8 migraine headache episodes with aura per month Can differentiate a migraine headache from other types of headaches Participant is post-menopausal, sterilized, not breastfeeding, her pregnancy test is negative Exclusion Criteria: Women who are pregnant or breastfeeding Routinely experiences any other type of headache that would confound discrimination from migraine headache with aura Have migraine with prolonged aura > 60 minutes Have headaches due to other underlying pathology Have headaches related to head or neck trauma Overuse headache medications: Has an intracranial metallic or Transcranial Magnetic Stimulation (TMS) implant or other metallic implants Has cardiac pacemaker or any other implanted electronic device Has any known history of alcohol abuse, drug dependency, or significant psychiatric illness in the previous 12 months Having any medical condition, including but not limited to: clinically significant renal or hepatic disease; uncontrolled hypertension; clinically significant coronary vascular disease not stable for the past 6 months; personal or family history of seizures or taking medications for seizures or drugs that may lower seizure threshold, cerebral vascular ischemia; infarct; hemorrhage, or other central nervous system disease (e.g., multiple sclerosis, amyotrophic lateral sclerosis); unstable metabolic disease, hypoglycemia or diabetes; malignancy within the past 5 years excluding cutaneous basal cell carcinoma; tuberculosis Has participated in any other investigational study within the previous 30 days. Cannot place the device within 1 cm of the scalp.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Lipton, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Headache Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Diamond Headache Clinic, LTD
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Michigan Head Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Westside Family Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Clinvest, Inc.
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Mercy Health Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Kirchner Headache Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Montefiore Headache Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Jefferson Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Nashville Neuroscience Group
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Innovative Clinical Research Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Swedish Headache Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20206581
Citation
Lipton RB, Dodick DW, Silberstein SD, Saper JR, Aurora SK, Pearlman SH, Fischell RE, Ruppel PL, Goadsby PJ. Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial. Lancet Neurol. 2010 Apr;9(4):373-80. doi: 10.1016/S1474-4422(10)70054-5. Epub 2010 Mar 4.
Results Reference
derived

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

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