Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura - Full Text View

Sponsor:	Neuralieve
Information provided by:	Neuralieve
ClinicalTrials.gov Identifier:	NCT00449540

Purpose

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.

Condition	Intervention	Phase
Migraine With Aura	Device: Active Transcranial Magnetic Stimulation (TMS) Device Device: Sham TMS Device	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by Neuralieve:

Primary Outcome Measures:

Percentage of Participants Experiencing no Pain at Two Hours Post-treatment [ Time Frame: Two hours ] [ Designated as safety issue: No ]
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 [ Time Frame: two hours post treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: 2 hours post treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: 2 hours post treatment ] [ Designated as safety issue: No ]
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.

Enrollment:	201
Study Start Date:	August 2006
Study Completion Date:	March 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Active Transcranial Magnetic Stimulation (TMS) Device 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.	Device: Active Transcranial Magnetic Stimulation (TMS) Device Transcranial Magnetic Stimulation Device treatment
Sham Comparator: Sham TMS Device 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.	Device: Sham TMS Device Simulated Sham treatment without TMS delivery

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449540

Locations

United States, California
San Francisco Headache Clinic
San Francisco, California, United States, 94109
United States, Colorado
Mile High Research Center
Denver, Colorado, United States, 80218
United States, Illinois
Diamond Headache Clinic, LTD
Chicago, Illinois, United States, 60614
United States, Michigan
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
Westside Family Medical Center
Kalamazoo, Michigan, United States, 49009
United States, Missouri
Clinvest, Inc.
Springfield, Missouri, United States, 65807
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, Nebraska
Kirchner Headache Clinic
Omaha, Nebraska, United States, 68144
United States, New York
Montefiore Headache Center
Bronx, New York, United States, 10461
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Nashville Neuroscience Group
Nashville, Tennessee, United States, 37203
United States, Virginia
The Innovative Clinical Research Center
Alexandria, Virginia, United States, 22304
United States, Washington
Swedish Headache Center
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Neuralieve

Investigators

Principal Investigator:

Richard B Lipton, MD

Albert Einstein College of Medicine of Yeshiva University

More Information

No publications provided by Neuralieve

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

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. Epub 2010 Mar 4.

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

Keywords provided by Neuralieve:

Migraine with aura
aura
TMS

Additional relevant MeSH terms:

Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012